Patrice Wendling

DETROIT - Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 surgeons over the next 20 years.

"We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bidding wars," Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

"In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today."

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical specialties: obstetrics and gynecology, orthopedic surgery, general surgery, otolaryngology, urology, neurosurgery, and thoracic surgery (Ann. Surg. 2009;250:590-7)

The current analysis went one step further, focusing on the average recruitment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population receiving care at urban and rural hospitals will remain constant, Dr. Williams explained.

Currently, the American Hospital Association estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hospitals serving 18% or 56 million Americans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and retain 4,175 surgeons per year or 27.7 surgeons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dramatic loss of general surgeons.

"In rural hospitals, general surgery is essential," he said. "[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their administrators of retiring or leaving in 2 years. Thirty-three percent of rural hospitals are recruiting now."

Factors that might make rural recruitment more difficult include professional and social isolation, cross coverage, insufficient training for the variety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, independence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon toward a rural hospital is doing a residency in a rural training program. The researchers estimate that half of general surgery residents who rotate through such a program will go on to practice in rural towns.

"It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals," Dr. Williams said.

Consideration of the needs of the surgeon’s family is another factor. Typically, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician couple. Thus, educational loan repayment could be a potential "trump card" for rural hospitals in the future, he said.

Rural hospitals are already throwing out the welcome mat. Most offer hiring incentives such as a relocation allowance; signing bonus; health, disability, and life insurance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hospitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

"In many general surgery programs in the United States, senior residents are receiving as many as 50 offers for employment today," he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an orthopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full benefits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Soper, chair of the department of surgery at Northwestern University in Chicago, said, "It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done."

Dr. Sober suggested that the basic problem is not so much the division between rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhagwan Satiani replied that the analysis included a simplified version of the federal model used to calculate supply and demand, but added that every projection in the last 50-75 years has been wrong. "You have to look at this model and say, ‘This is the best we can do right now," he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive medical school rural program (MSRP). "If you took 10 medical students out of the class and put them into the MSRP program, you could double the number of rural surgeons. That’s how important that is," said Dr. Satiani, medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia provides a similar calculation for rural physicians and reports that 79%-87% of graduates from the two MSRPs with long-range rural outcomes – the PSAP and University of Minnesota at Duluth – remained in rural practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Affordable Care Act authorized a new Rural Physician Training Grants program to provide grants to medical schools to develop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be considered programs that attract rural surgeons, according to Dr. Satiani. "I think American surgery is going to have to give this a separate tract within residency programs."

Audience member Dr. Mark Malangoni, associate executive director of the American Board of Surgery in Philadelphia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Washington state. He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural areas.

Finally, several audience members suggested that efforts need to be made to eliminate the perception among residents that surgical specialists are somehow better than general surgeons.

"It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists," Dr. Satiani said. "I think it has to come from the programs and the leadership; defining general surgery better, even going as far as changing the name, if that becomes an important issue."

When asked in an interview what that new name might be, Dr. Satiani said the terms "master surgeon" and "omni surgeon" have been floated, with master surgeon more likely to resonate with the general public.

The authors reported no conflicts of interest.

DETROIT - Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 surgeons over the next 20 years.

"We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bidding wars," Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

"In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today."

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical specialties: obstetrics and gynecology, orthopedic surgery, general surgery, otolaryngology, urology, neurosurgery, and thoracic surgery (Ann. Surg. 2009;250:590-7)

The current analysis went one step further, focusing on the average recruitment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population receiving care at urban and rural hospitals will remain constant, Dr. Williams explained.

Currently, the American Hospital Association estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hospitals serving 18% or 56 million Americans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and retain 4,175 surgeons per year or 27.7 surgeons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dramatic loss of general surgeons.

"In rural hospitals, general surgery is essential," he said. "[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their administrators of retiring or leaving in 2 years. Thirty-three percent of rural hospitals are recruiting now."

Factors that might make rural recruitment more difficult include professional and social isolation, cross coverage, insufficient training for the variety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, independence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon toward a rural hospital is doing a residency in a rural training program. The researchers estimate that half of general surgery residents who rotate through such a program will go on to practice in rural towns.

"It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals," Dr. Williams said.

Consideration of the needs of the surgeon’s family is another factor. Typically, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician couple. Thus, educational loan repayment could be a potential "trump card" for rural hospitals in the future, he said.

Rural hospitals are already throwing out the welcome mat. Most offer hiring incentives such as a relocation allowance; signing bonus; health, disability, and life insurance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hospitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

"In many general surgery programs in the United States, senior residents are receiving as many as 50 offers for employment today," he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an orthopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full benefits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Soper, chair of the department of surgery at Northwestern University in Chicago, said, "It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done."

Dr. Sober suggested that the basic problem is not so much the division between rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhagwan Satiani replied that the analysis included a simplified version of the federal model used to calculate supply and demand, but added that every projection in the last 50-75 years has been wrong. "You have to look at this model and say, ‘This is the best we can do right now," he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive medical school rural program (MSRP). "If you took 10 medical students out of the class and put them into the MSRP program, you could double the number of rural surgeons. That’s how important that is," said Dr. Satiani, medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia provides a similar calculation for rural physicians and reports that 79%-87% of graduates from the two MSRPs with long-range rural outcomes – the PSAP and University of Minnesota at Duluth – remained in rural practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Affordable Care Act authorized a new Rural Physician Training Grants program to provide grants to medical schools to develop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be considered programs that attract rural surgeons, according to Dr. Satiani. "I think American surgery is going to have to give this a separate tract within residency programs."

Audience member Dr. Mark Malangoni, associate executive director of the American Board of Surgery in Philadelphia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Washington state. He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural areas.

Finally, several audience members suggested that efforts need to be made to eliminate the perception among residents that surgical specialists are somehow better than general surgeons.

"It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists," Dr. Satiani said. "I think it has to come from the programs and the leadership; defining general surgery better, even going as far as changing the name, if that becomes an important issue."

When asked in an interview what that new name might be, Dr. Satiani said the terms "master surgeon" and "omni surgeon" have been floated, with master surgeon more likely to resonate with the general public.

The authors reported no conflicts of interest.

DETROIT - Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 surgeons over the next 20 years.

"We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bidding wars," Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

"In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today."

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical specialties: obstetrics and gynecology, orthopedic surgery, general surgery, otolaryngology, urology, neurosurgery, and thoracic surgery (Ann. Surg. 2009;250:590-7)

The current analysis went one step further, focusing on the average recruitment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population receiving care at urban and rural hospitals will remain constant, Dr. Williams explained.

Currently, the American Hospital Association estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hospitals serving 18% or 56 million Americans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and retain 4,175 surgeons per year or 27.7 surgeons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dramatic loss of general surgeons.

"In rural hospitals, general surgery is essential," he said. "[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their administrators of retiring or leaving in 2 years. Thirty-three percent of rural hospitals are recruiting now."

Factors that might make rural recruitment more difficult include professional and social isolation, cross coverage, insufficient training for the variety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, independence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon toward a rural hospital is doing a residency in a rural training program. The researchers estimate that half of general surgery residents who rotate through such a program will go on to practice in rural towns.

"It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals," Dr. Williams said.

Consideration of the needs of the surgeon’s family is another factor. Typically, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician couple. Thus, educational loan repayment could be a potential "trump card" for rural hospitals in the future, he said.

Rural hospitals are already throwing out the welcome mat. Most offer hiring incentives such as a relocation allowance; signing bonus; health, disability, and life insurance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hospitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

"In many general surgery programs in the United States, senior residents are receiving as many as 50 offers for employment today," he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an orthopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full benefits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Soper, chair of the department of surgery at Northwestern University in Chicago, said, "It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done."

Dr. Sober suggested that the basic problem is not so much the division between rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhagwan Satiani replied that the analysis included a simplified version of the federal model used to calculate supply and demand, but added that every projection in the last 50-75 years has been wrong. "You have to look at this model and say, ‘This is the best we can do right now," he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive medical school rural program (MSRP). "If you took 10 medical students out of the class and put them into the MSRP program, you could double the number of rural surgeons. That’s how important that is," said Dr. Satiani, medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia provides a similar calculation for rural physicians and reports that 79%-87% of graduates from the two MSRPs with long-range rural outcomes – the PSAP and University of Minnesota at Duluth – remained in rural practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Affordable Care Act authorized a new Rural Physician Training Grants program to provide grants to medical schools to develop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be considered programs that attract rural surgeons, according to Dr. Satiani. "I think American surgery is going to have to give this a separate tract within residency programs."

Audience member Dr. Mark Malangoni, associate executive director of the American Board of Surgery in Philadelphia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Washington state. He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural areas.

Finally, several audience members suggested that efforts need to be made to eliminate the perception among residents that surgical specialists are somehow better than general surgeons.

"It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists," Dr. Satiani said. "I think it has to come from the programs and the leadership; defining general surgery better, even going as far as changing the name, if that becomes an important issue."

When asked in an interview what that new name might be, Dr. Satiani said the terms "master surgeon" and "omni surgeon" have been floated, with master surgeon more likely to resonate with the general public.

The authors reported no conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

DETROIT – Benchmarking trauma center performance using traditional measures fails to adequately reflect the aging face of trauma deaths today, a new study suggests.

Increased public awareness of advance directives and an aging population has shifted the demographics of trauma mortality, Dr. Glen A. Franklin said at the annual meeting of the Central Surgical Association.

"Traditional measures of trauma center quality based on injury severity or comorbidity indexing may not capture all the issues associated with mortality," he said.

Dr. Franklin and his colleagues at the University of Louisville in Kentucky studied the effects of advance directives and futile care on trauma center mortality by examining all trauma deaths in 2008-2009 to determine the proportion of patients whose outcome could have been changed by medical care.

Of the 5,433 patients treated, 347 died, resulting in a crude mortality of 6.4%. Advance directives were in place in 18% of patients at the time of admission, said Dr. Franklin, director of the university’s critical care/trauma fellowship program.

Care was withdrawn in 147 deaths (42%) at a median of 1.5 days. The median injury severity score was 25 for all patients who died (both those who did and those who did not have care withdrawn). Most deaths (66%) occurred early in the hospital course, within 48 hours or less, and the decision for withdrawal of care was made within that time frame in 24% of cases.

On univariate analysis, only age (69.5 years vs. 48 years) and the presence of an advance directive (69% vs. 31%) were significantly different between patients in whom care was or was not withdrawn. Injury severity score did not correlate with withdrawal of care (odds ratio 1.014), he said.

Patients with advance directives were significantly older than those without advance directives (72 years vs. 53 years) and were three times as likely to have care withdrawn (OR 3.11). The decision to withdraw care was made by family members in 140 cases (95%), by the patient in 6, and by power of attorney in 1.

Of the patients who died, 69 patients (20%) arrived at the trauma center in or rapidly progressed to cardiac arrest, and were placed in the futile-care category. A vigorous quality improvement review process indicated that medical care could not have been reasonably expected to impact survival in 62% (215 deaths), Dr. Franklin said. Only 12 deaths were considered potentially preventable.

When these factors are taken into account, the hospital’s overall crude death rate of 6.4% fell to 3.7% when adjusted for the 147 patients with care withdrawn (200 deaths remaining/5,433 cases) and further to 2.4% when adjusted for the 69 futile care patients (131 deaths remaining/5,433 cases).

According to information from the National Trauma Data Bank, trauma patient volume and injury severity are high at the University of Louisville, but so is the center’s mortality.

"It is this type of [nonadjusted] data that is making it out into the public sector, with really no ability for the layperson to interpret its meaning," Dr. Franklin said.

Risk-adjusted data will soon be available via the American College of Surgeons’ recently launched Trauma Quality Improvement Program (TQIP), he observed. The program mimics the National Surgical Quality Improvement Program (NSQIP) and looks at observed-to-expected mortality ratio in a risk-adjusted fashion. In a recent study using this approach, only 9 of 132 centers in the United States were identified as being above-average performers with regard to elderly trauma after adjustment for case mix (Ann. Surg. 2011;253:144-50), he added.

Dr. Franklin observed that societal, cultural, regional, religious, and racial factors can affect family perceptions of appropriate escalation of care and thus mortality outcomes. For example, emergency medical technicians in Kentucky cannot declare trauma patients dead, and paramedics can do so only under extreme circumstances such as decapitation or rigor mortis. As a result, deceased patients who arrive in the trauma center may be subjected to inappropriate resuscitation attempts, and ultimately figure in the trauma center’s mortality profile, he said. For another example, the decision to withdraw care may be made more conservatively when caring for patients in the Bible Belt, where religious beliefs are more likely to play a role in attitudes toward the end of life.

"We believe all of these factors need to be placed into the data set in some manner to affect trauma center performance, particularly as transparency becomes a key in the quality movement," he concluded.

Invited discussant Dr. Mark Hemmila of the University of Michigan, Ann Arbor, asked whether do-not-resuscitate (DNR) status prior to injury or surgery, data that are collected by both NSQIP and TQIP, might be a reasonable compromise for use as a covariate in risk adjustment of mortality data. He went on to ask whether trauma centers would collect this data accurately or whether there was potential to rig the system.

Dr. Franklin said that inclusion of DNR status or withdrawal of care in a data model could be problematic unless the terms are clearly defined beforehand. He noted, for example, that a DNR order may not be written in the chart for some patients, but that it is clear physicians are writing for comfort care measures when they extubate a patient, increase their pain medications, and move them out of a monitored setting. Although the potential exists to game the system and data entry needs to be reinforced, the data system itself is okay, according to Dr. Franklin.

Finally, it was noted by members of the audience that the medical community has not done a good job of educating the public on such issues as withdrawal of care, DNR orders, and palliative care, and that these issues will become more pressing as the population ages. When asked whether the researchers looked at race, Dr. Franklin said they did not, but that anecdotally, minorities were less likely to withdraw care.

Dr. Franklin and his coauthors disclosed no relevant conflicts of interest.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Survival is nearly identical in early-stage breast cancer regardless of whether or not bone marrow micrometastases are present, according to the prospective Swiss Multicenter Study Group trial.

Among 410 women with T1 and T2 disease and no palpable axillary lymph nodes, the 5-year overall survival was 92.5% with bone marrow micrometastases (BMM) and 92.7% without (P = .85).

Dr. Igor Langer

The 5-year disease-free survival reached 92.2% in patients with BMM and 93.6% in those without (P = .50), Dr. Igor Langer said during a plenary session at a symposium sponsored by the Society of Surgical Oncology. Micrometastases were detected in 118 patients (29%).

Audience members asked Dr. Langer to explain his findings in light of those from the ACOSOG (American College of Surgeons Oncology Group) Z0010 trial, which also involved T1 and T2 disease. In that trial, BMMs were detected by immunohistochemistry in just 3% of women, and were associated with a significantly lower 5-year survival rate of 90% vs. 95% in patients without BMMs, according to data presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Dr. Langer of the department of surgery at the Lindenhofspital in Bern, Switzerland, replied that most studies looking for BMM can identify them in 15%-40% of patients. "So I don’t know if it is a methodological difference, in terms of preparation of the bone marrow and identification of these cells," he said. "The difference in prognosis is multifactorial."

He pointed out that there is no standardized method to detect BMMs, that different methods were used to identify sentinel lymph nodes (SLNs), that patients received different adjuvant regimens, and that the number of cases who developed BMMs was so low, it could easily change outcomes.

Another attendee asked whether there is a particular cutoff for BMMs, noting that in many cancers the presence of micrometastases has no impact on survival, and that they are prognostic in melanoma only when they are at least 0.2 mm in the lymph nodes. Dr. Langer said that the median number of tumor cells in the analysis was two, but he balked at the possibility of using BMM testing in early breast cancer.

"You shouldn’t do the bone marrow aspiration," he said in an interview. "It might have prognostic impact, but if it doesn’t drive your therapy – if it doesn’t influence what you are doing – you have findings and you don’t know what to do with them. It’s too immature. We first have to standardize the testing."

Dr. Langer reported on 659 women from 13 Swiss centers who underwent intraoperative SLN examination by frozen section and paraffin serial sectioning at a cutting interval of 250 mcm with H&E (hematoxylin and eosin) staining and immunohistochemistry.

As previously reported, SLNs were identified in 98% of patients, including 71% with T1 disease and 29% with T2 disease (Breast Cancer Res. Treat. 2009;113:129-36). Their median age was 59 years, and 80% were postmenopausal. The median tumor size was 17 mm.

Of the 659 patients, 410 also underwent bone marrow aspiration from both iliac crests; these formed the basis of the current analysis. The mononuclear cells of the bone marrow aspirates were isolated by density gradient centrifugation through Ficoll. In all, 2 million bone marrow cells were evaluated, and the presence of one or more tumor cells was regarded as BMM positive, Dr. Langer said.

Cancer cells were stained with monoclonal antibodies A45-B/B3 against cytokeratin 8, 18, and 19 and were counted by an automated, computerized digital microscope. All results were reviewed by one pathologist.

Bone marrow micrometastases were detected in 118 (28.8%) of the 410 women. About 210 women were SLN negative and BMM negative, although considerable discordance was observed, Dr. Langer said. In all, 67 women (16.4%) were BMM positive and SLN negative, whereas 82 women (20%) were BMM negative and SLN positive.

In multivariate logistic regression analysis that included tumor size, tumor grade, tumor receptor status, and menopausal status, the presence of positive SLNs was the only significant independent predictor for the presence of BMM (P = .007; odds ratio, 1.860). T stage was not significant; only N stage was, he said.

In the earlier published analysis, the Swiss researchers identified SLN micrometastases or isolated tumor cells in 47 patients who underwent delayed ALND (axillary lymph node dissection). In 96% of these patients, the second operation was not beneficial because the ALND specimens were free of macrometastases. This finding – coupled with an overall accuracy of frozen section of 90% in the detection of SLN macrometastases – led the group to strongly recommend the routine use of SLN frozen section in early-stage breast cancer.

The recently published ACOSOG Z0011 trial concluded that ALND offers no survival advantage over SLN dissection alone in women with T1-T2 invasive breast cancer with no palpable adenopathy and one or two lymph nodes that contain metastases identified by frozen section, touch preparation, or H&E staining.

Sentinel node micrometastases (defined as H&E tumor deposits no greater than 2 mm in size) were identified in 37.5% of patients in the ALND group vs. 45% of those in the SLND group (JAMA 2011;305:569-75).

The Swiss Group for Clinical Cancer Research and the Cancer League of Basel-Stadt and Basel-Land funded the study. Dr. Langer and his coauthors disclosed no conflicts.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR-positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR-positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR-positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Overall patterns of recurrence are similar regardless of whether patients achieve a pathologic complete response after neoadjuvant therapy for gastric and gastroesophageal junction cancer, results of a retrospective study indicate.

Pathologic complete response (pCR) following preoperative therapy is associated with improved survival in several other solid tumors, including breast, esophageal, lung, and rectal cancer. However, recurrence and survival in patients with gastric or gastroesophageal junction (GEJ) cancer achieving a pCR after preoperative treatment are not well characterized.

To elucidate the pattern and timing of these outcomes, Dr. Ryan Fields and his associates reviewed 2,676 patients in a prospective database who underwent curative resection for gastric/GEJ cancer from 1985 to 2009 at Memorial Sloan-Kettering Cancer Center in New York. Of these, 714 received preoperative chemotherapy with or without radiation, and 105 patients were excluded from analysis for metastatic disease or positive surgical margin. Among the 609 remaining patients, 60 (10%) achieved a pCR and 549 did not.

Achieving a pCR was heavily dependent on tumor location and/or use of preoperative chemoradiation therapy, Dr. Fields said at a symposium sponsored by the Society of Surgical Oncology. A pCR occurred in 17% of patients treated with chemoradiation therapy vs. only 4% undergoing chemotherapy alone. Among the 60 pCR patients, 78% had GEJ and 22% had gastric tumors.

After 46 months of follow-up, 14 of the pCR patients developed a recurrence, with all but 1 occurring within 2 years of surgery. A total of 233 (42%) non-pCR patients had a recurrence.

"In patients that achieve a pCR, there remains a significant rate of recurrence – 27% at 5 years," said Dr. Fields, a surgeon with the center’s gastric and mixed tumor service.

By comparison, the 5-year incidence of recurrence for non-pCR stage I and II patients was 25% and 39% (P = .49 and P = .36, respectively), and reached a full 74% for non-pCR stage III patients (P less than .001).

"The incidence of recurrence between pCR and non-pCR stage I and II patients is really equivalent," said Dr. Fields. "It’s only significantly worse for non-pCR patients who are stage III with involved lymph nodes after preoperative treatment."

The site of first recurrence was local/regional in 43% of both pCR and non-pCR patients (P = 1.0). "I think this speaks to the fact that we still need to consider local/regional surveillance in this patient population, despite the fact that they achieved a complete response," he said.

Five pCR patients and 10 non-pCR patients experienced brain metastases as the site of first recurrence. This represents 36% of all pCR recurrences, compared with 4% of all non-pCR recurrences, a significant difference (P = .01).

Importantly, all of these patients presented symptomatically, with either seizures or focal neurologic deficits, Dr. Fields said. The average time to central nervous system recurrence was 12 months (range 5-24 months), and the average time from recurrence to death after CNS recurrence was 10 months (range 2-26 months).

"These numbers are small – 5 out of 60 patients – but it puts forth the consideration of brain imaging in these patients to try to identify CNS recurrences before the onset of symptoms in this select cohort," he said.

Finally, compared with non-pCR patients, pCR patients experienced significant improvements in disease-specific survival (27% vs. 51%, P = .006) and in recurrence-free survival (73% vs. 51%, P = .01). While survival outcomes as a whole were improved in the pCR patients, all of this can be attributed to the contribution of the non-pCR stage III patients, Dr. Fields noted.

When asked during a discussion of the study what is so special about chemoradiation vs. chemotherapy alone, Dr. Fields replied that the chemotherapy regimens, given alone or with radiation, comprise different drugs and thus would be expected to have different efficacies. In addition, because all the tumors that received radiation were GEJ tumors, it is unclear whether the difference in pCR rate was caused by radiation, tumor location/biology, or both.

"We are certainly finding out that there are significant molecular differences between GEJ and gastric body tumors," he said in an interview. "For example, HER2 expression is quite different between tumors in these locations. Similarly, these tumors may respond very differently to chemotherapy and radiation and give different pCR rates to these treatments."

Dr. Fields and his coauthors disclosed no conflicts of interest.

SAN ANTONIO – Overall patterns of recurrence are similar regardless of whether patients achieve a pathologic complete response after neoadjuvant therapy for gastric and gastroesophageal junction cancer, results of a retrospective study indicate.

Pathologic complete response (pCR) following preoperative therapy is associated with improved survival in several other solid tumors, including breast, esophageal, lung, and rectal cancer. However, recurrence and survival in patients with gastric or gastroesophageal junction (GEJ) cancer achieving a pCR after preoperative treatment are not well characterized.

To elucidate the pattern and timing of these outcomes, Dr. Ryan Fields and his associates reviewed 2,676 patients in a prospective database who underwent curative resection for gastric/GEJ cancer from 1985 to 2009 at Memorial Sloan-Kettering Cancer Center in New York. Of these, 714 received preoperative chemotherapy with or without radiation, and 105 patients were excluded from analysis for metastatic disease or positive surgical margin. Among the 609 remaining patients, 60 (10%) achieved a pCR and 549 did not.

Achieving a pCR was heavily dependent on tumor location and/or use of preoperative chemoradiation therapy, Dr. Fields said at a symposium sponsored by the Society of Surgical Oncology. A pCR occurred in 17% of patients treated with chemoradiation therapy vs. only 4% undergoing chemotherapy alone. Among the 60 pCR patients, 78% had GEJ and 22% had gastric tumors.

After 46 months of follow-up, 14 of the pCR patients developed a recurrence, with all but 1 occurring within 2 years of surgery. A total of 233 (42%) non-pCR patients had a recurrence.

"In patients that achieve a pCR, there remains a significant rate of recurrence – 27% at 5 years," said Dr. Fields, a surgeon with the center’s gastric and mixed tumor service.

By comparison, the 5-year incidence of recurrence for non-pCR stage I and II patients was 25% and 39% (P = .49 and P = .36, respectively), and reached a full 74% for non-pCR stage III patients (P less than .001).

"The incidence of recurrence between pCR and non-pCR stage I and II patients is really equivalent," said Dr. Fields. "It’s only significantly worse for non-pCR patients who are stage III with involved lymph nodes after preoperative treatment."

The site of first recurrence was local/regional in 43% of both pCR and non-pCR patients (P = 1.0). "I think this speaks to the fact that we still need to consider local/regional surveillance in this patient population, despite the fact that they achieved a complete response," he said.

Five pCR patients and 10 non-pCR patients experienced brain metastases as the site of first recurrence. This represents 36% of all pCR recurrences, compared with 4% of all non-pCR recurrences, a significant difference (P = .01).

Importantly, all of these patients presented symptomatically, with either seizures or focal neurologic deficits, Dr. Fields said. The average time to central nervous system recurrence was 12 months (range 5-24 months), and the average time from recurrence to death after CNS recurrence was 10 months (range 2-26 months).

"These numbers are small – 5 out of 60 patients – but it puts forth the consideration of brain imaging in these patients to try to identify CNS recurrences before the onset of symptoms in this select cohort," he said.

Finally, compared with non-pCR patients, pCR patients experienced significant improvements in disease-specific survival (27% vs. 51%, P = .006) and in recurrence-free survival (73% vs. 51%, P = .01). While survival outcomes as a whole were improved in the pCR patients, all of this can be attributed to the contribution of the non-pCR stage III patients, Dr. Fields noted.

When asked during a discussion of the study what is so special about chemoradiation vs. chemotherapy alone, Dr. Fields replied that the chemotherapy regimens, given alone or with radiation, comprise different drugs and thus would be expected to have different efficacies. In addition, because all the tumors that received radiation were GEJ tumors, it is unclear whether the difference in pCR rate was caused by radiation, tumor location/biology, or both.

"We are certainly finding out that there are significant molecular differences between GEJ and gastric body tumors," he said in an interview. "For example, HER2 expression is quite different between tumors in these locations. Similarly, these tumors may respond very differently to chemotherapy and radiation and give different pCR rates to these treatments."

Dr. Fields and his coauthors disclosed no conflicts of interest.

SAN ANTONIO – Overall patterns of recurrence are similar regardless of whether patients achieve a pathologic complete response after neoadjuvant therapy for gastric and gastroesophageal junction cancer, results of a retrospective study indicate.

Pathologic complete response (pCR) following preoperative therapy is associated with improved survival in several other solid tumors, including breast, esophageal, lung, and rectal cancer. However, recurrence and survival in patients with gastric or gastroesophageal junction (GEJ) cancer achieving a pCR after preoperative treatment are not well characterized.

To elucidate the pattern and timing of these outcomes, Dr. Ryan Fields and his associates reviewed 2,676 patients in a prospective database who underwent curative resection for gastric/GEJ cancer from 1985 to 2009 at Memorial Sloan-Kettering Cancer Center in New York. Of these, 714 received preoperative chemotherapy with or without radiation, and 105 patients were excluded from analysis for metastatic disease or positive surgical margin. Among the 609 remaining patients, 60 (10%) achieved a pCR and 549 did not.

Achieving a pCR was heavily dependent on tumor location and/or use of preoperative chemoradiation therapy, Dr. Fields said at a symposium sponsored by the Society of Surgical Oncology. A pCR occurred in 17% of patients treated with chemoradiation therapy vs. only 4% undergoing chemotherapy alone. Among the 60 pCR patients, 78% had GEJ and 22% had gastric tumors.

After 46 months of follow-up, 14 of the pCR patients developed a recurrence, with all but 1 occurring within 2 years of surgery. A total of 233 (42%) non-pCR patients had a recurrence.

"In patients that achieve a pCR, there remains a significant rate of recurrence – 27% at 5 years," said Dr. Fields, a surgeon with the center’s gastric and mixed tumor service.

By comparison, the 5-year incidence of recurrence for non-pCR stage I and II patients was 25% and 39% (P = .49 and P = .36, respectively), and reached a full 74% for non-pCR stage III patients (P less than .001).

"The incidence of recurrence between pCR and non-pCR stage I and II patients is really equivalent," said Dr. Fields. "It’s only significantly worse for non-pCR patients who are stage III with involved lymph nodes after preoperative treatment."

The site of first recurrence was local/regional in 43% of both pCR and non-pCR patients (P = 1.0). "I think this speaks to the fact that we still need to consider local/regional surveillance in this patient population, despite the fact that they achieved a complete response," he said.

Five pCR patients and 10 non-pCR patients experienced brain metastases as the site of first recurrence. This represents 36% of all pCR recurrences, compared with 4% of all non-pCR recurrences, a significant difference (P = .01).

Importantly, all of these patients presented symptomatically, with either seizures or focal neurologic deficits, Dr. Fields said. The average time to central nervous system recurrence was 12 months (range 5-24 months), and the average time from recurrence to death after CNS recurrence was 10 months (range 2-26 months).

"These numbers are small – 5 out of 60 patients – but it puts forth the consideration of brain imaging in these patients to try to identify CNS recurrences before the onset of symptoms in this select cohort," he said.

Finally, compared with non-pCR patients, pCR patients experienced significant improvements in disease-specific survival (27% vs. 51%, P = .006) and in recurrence-free survival (73% vs. 51%, P = .01). While survival outcomes as a whole were improved in the pCR patients, all of this can be attributed to the contribution of the non-pCR stage III patients, Dr. Fields noted.

When asked during a discussion of the study what is so special about chemoradiation vs. chemotherapy alone, Dr. Fields replied that the chemotherapy regimens, given alone or with radiation, comprise different drugs and thus would be expected to have different efficacies. In addition, because all the tumors that received radiation were GEJ tumors, it is unclear whether the difference in pCR rate was caused by radiation, tumor location/biology, or both.

"We are certainly finding out that there are significant molecular differences between GEJ and gastric body tumors," he said in an interview. "For example, HER2 expression is quite different between tumors in these locations. Similarly, these tumors may respond very differently to chemotherapy and radiation and give different pCR rates to these treatments."

Dr. Fields and his coauthors disclosed no conflicts of interest.