Patrice Wendling

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.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What’s driving the improved outcomes isn’t entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline–compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don’t get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It’s not the initiation that counts. It’s whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.

Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – Positive margin and reoperation rates were similar for radio-guided seed localization and wire-guided localization of nonpalpable breast tumors in a prospective multicenter trial – in contrast to results from previous studies.

In an intent-to-treat analysis of 305 women with confirmed invasive or ductal carcinoma in situ who were undergoing localization and breast-conserving surgery, positive margin rates were 10.5% for radio-guided seed localization (RSL) and 11.9% for wire-guided localization (P = .990).

Rates of positive plus close margins (defined as disease within less than 1 mm) were 19% for the seed group and 22% for the wire group (P = .609), Dr. Peter Lovrics reported at a symposium sponsored by the Society of Surgical Oncology.

Rates of reoperation – either re-excision of margins or mastectomy – were also similar (19% and 15%, respectively) in the wire and seed groups, said Dr. Lovrics of the department of surgery at McMaster University in Hamilton, Ont.

The feasibility of RSL for identifying occult breast tumors was first reported a little more than a decade ago, and RSL has been rapidly adopted in many European countries. The procedure involves intratumoral injection of a radiotracer to identify the primary tumor and sentinel lymph nodes for intraoperative gamma probe–guided dissection.

In a recent literature review of 12 studies, Dr. Lovrics and his associates found that RSL yields lower positive margins (odds ratio, 0.367) and fewer reoperations (OR, 0.347) than does wire-guided localization, and three of those studies also suggested improved cosmesis (Eur. J. Surg. Oncol. 2011 Feb. 16 [E-pub ahead of print]).

When asked why RSL failed to produce significantly better outcomes, Dr. Lovrics said it may be that with a larger sample size, RSL would be potentially better, yielding results similar to those of other studies. Notably, overall positive margin rates were low for both groups and were much higher for wire-guided localization in most other studies.

"This may be partially attributed to the fact that all patients had a preoperative core biopsy and a confirmed diagnosis of cancer, so all of the procedures were definitive operations," he said in an interview. "In some other studies, not all patients had confirmed cancer and some operations were diagnostic in intent. Otherwise, the study population was typical – similar to other studies in tumor characteristics."

In the current study, there were 152 patients in the seed group and 153 in the wire group, with 6 patients crossing over to the wire group because the seed did not arrive at the hospital on the day of surgery. Mammogram findings included a mass in 47% of the wire group and in 50% of the seed group, and microcalcifications in 11% and 14%, respectively. Three-fourths of patients had a mass present on ultrasonography. Their average age was 60 years.

Secondary outcomes between groups were very similar, except for a significantly shorter operative time of 19 minutes with seed localization vs. 22 minutes in the wire group (P less than .001), Dr. Lovrics said. Excision difficulty was also ranked significantly easier for surgeons with seed localization (P = .008).

Factors such as skin removal and whether the dissection was taken to the chest wall were similar, as were the number of additional cavity margins excised and postoperative complications at 1 month, he said during a breast-focused plenary session.

Pain-reported anxiety during localization was similar in both groups, although patients in the seed group reported significantly less pain during the localization procedure than did those in the wire group (P = 0.38). An analysis of cosmetic results is ongoing.

Dr. Lovrics said that RSL allows exquisite and precise localization of the tumor, and that radiation exposure to patients and health care workers is negligible.

"For the surgeon, it provides very real-time, enhanced guidance for localization and is preferred by surgeons," he concluded. "Radio-seed localization is an acceptable alternative to wire-guided localization."

During a discussion of the study, audience members asked whether a cost analysis had been performed and whether the seeds were placed on the day of the surgery. Dr. Lovrics said the seeds and the wire both cost about $50, and that they currently place the seed on the day of surgery, but they hope to insert it earlier to further reduce OR time.

When asked whether a radiograph is still needed after seed localization, Dr. Lovrics said that a postoperative radiograph is still essential because of the risk of seed migration. Seeds were misplaced in four cases, one seed migrated, one wire migrated, and one wire fell out.

The Canadian Breast Cancer Foundation funded the study. Dr. Lovrics and his coauthors reported no conflicts of interest.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

SAN ANTONIO – The development of a serum glycoprotein microarray has led to the discovery of four proteins for which antibodies significantly predict nodal metastases in patients with melanoma.

If validated, the data could form the basis of a blood test to select patients for sentinel lymph node biopsy, Dr. Michael Sabel said during a symposium sponsored by the Society of Surgical Oncology.

In an internal validation cohort of 79 patients with newly diagnosed melanoma, 22 patients (28%) had serum antibodies to acid ceramidase (ASAH1), cathepsin D (CTSD), or lactate dehydrogenase B (LDHB) that were significantly associated with being node negative (P value less than .0001; hazard ratio, 0.173).

"This isn't a small percentage of patients, so if validated, this test could significantly reduce the number of patients to whom we offer sentinel node biopsy," he said in an interview.

Antibodies to a fourth protein, GRP94 (also known as heat shock protein 90), were detected in nine patients (11%), and were significantly associated with being node positive (P less than .0001; HR, 3.04).

"Theoretically, this could be used in patients who are on the borderline for the procedure, where the presence of antibodies to GRP94 could prompt you to use sentinel node biopsy," Dr. Sabel said.

Surprisingly, the presence of antibodies to GRP94 did not correlate with the volume of disease burden within the sentinel node. The antibodies were equally present in patients who had microscopic disease and in those with more significant tumor burden within their sentinel node.

The bigger picture, however, is the potential for glycoprotein microarray analysis to identify predictive and prognostic biomarkers in melanoma, suggested Dr. Sabel, a surgical oncologist with the University of Michigan Health Systems in Ann Arbor.

Studies are ongoing to find other antibodies and their relevant glycoproteins that may differentiate benign from malignant skin lesions, identify patients at high risk of distant metastases, and signal response to adjuvant therapies.

"Glycoproteins have apparently important roles in melanoma progression, and also may serve as targets for therapy," he said.

The use of serum autoantibody profiling would be particularly attractive in clinical practice because it does not require primary tumor tissue. Unlike most other solid tumors, roughly 90% of a primary melanoma tumor is removed during the initial biopsy, leaving little tissue for subsequent testing once the diagnosis has been made, Dr. Sabel said.

Sentinel node biopsy with selective lymph node dissection was endorsed in the latest American Joint Commission on Cancer staging guidelines for melanoma, but it is positive in only 20% of patients with melanoma, he observed.

The researchers studied glycoproteins rather than a broad array of proteins because glycoproteins have a strong interaction with the immune system. This is particularly advantageous in melanoma because the interaction between the immune system and melanoma is well documented. In addition, glycoproteins undergo distinct changes during cancer progression, including precancerous states and posttranslational modifications that are associated with disease progression, Dr. Sabel explained.

In order to perform serum autoantibody profiling, the researchers used dual-lectin affinity and reverse-phase chromatography to separate out glycoproteins from a whole cell lysate created from a metastatic melanoma cell line. The glycoproteins were spotted on a microarray and tested using serum from 43 melanoma patients, with anti–human IgG used to detect response, Dr. Sabel said.

Wilcoxon rank-sum testing and outlier analysis identified nine fractions that significantly separated 27 node-negative patients from 16 node-positive patients. Mass spectrometry was then used to identify the relevant proteins of interest. Prevalidation testing with recombinant proteins boiled down the nine fractions to the four proteins used in the validation set of 79 patients.

Interestingly, although LDHB, CTSD, and GRP94 have strong associations with melanoma, the ASAH1 protein has been associated with breast, thyroid, and prostate cancers, but not melanoma, Dr. Sabel said.

In multivariate analysis of the validation cohort, there was no significant correlation among the four proteins or between the proteins and known melanoma prognostic factors. Only a mild, negative correlation was observed between ASAHI and increasing age, he said.

All four antibodies remained significant after adjustment for age, sex, Breslow thickness, ulceration, and mitotic rate, with a receiver operating characteristic area under the curve of 0.8690.

Dr. Sabel disclosed research funding from Merck Oncology. His coauthors report no conflicts.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.