Patrice Wendling

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history and requires frequent dose adjustments. Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of VTE in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, showing noninferiority to warfarin for preventing recurrent or fatal VTE. After 6 months, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman reported at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and 1.9% of warfarin patients (HR 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was seen in no patients on dabigatran and three on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University, Hamilton, Ont., and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150-mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing, Dr. Schulman said the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Dr. Schulman suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin, such that 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

The trial results were published simultaneously in the New England Journal of Medicine (2009;361:2342–52 [doi:10.1056/NEJMoa0906598

My Take

Clinicians Eager to Replace Warfarin

A replacement for warfarin has been on just about every clinician's wish list for the last decade. The direct thrombin inhibitors currently hold the most promise.

Let's keep our fingers crossed that this class of drugs carries the same benefit as warfarin, with far fewer complications and far less monitoring.

Such a breakthrough would have instant impact. Early in my career I struggled with managing hyperlipidemia in my patients until statins appeared. Later, treating depression was a struggle until the SSRIs showed up.

This would be even bigger.

In his book “The Youngest Science,” Dr. Lewis Thomas wrote about promising opportunities in medicine that began developing more than 60 years ago. Those physicians now retired or long passed were astounded when antibiotics first became available and were put into practice.

Perhaps the next generation of practitioners will marvel that so many of us for so long anticoagulated our patients with “rat poison.”

Exciting times are still upon us.

ERIC G. TANGALOS, M.D., is a professor of medicine at the Mayo Clinic in Rochester, Minn. He reports no relevant conflicts of interest.

Dr. Tangalos

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history and requires frequent dose adjustments. Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of VTE in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, showing noninferiority to warfarin for preventing recurrent or fatal VTE. After 6 months, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman reported at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and 1.9% of warfarin patients (HR 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was seen in no patients on dabigatran and three on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University, Hamilton, Ont., and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150-mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing, Dr. Schulman said the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Dr. Schulman suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin, such that 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

The trial results were published simultaneously in the New England Journal of Medicine (2009;361:2342–52 [doi:10.1056/NEJMoa0906598

My Take

Clinicians Eager to Replace Warfarin

A replacement for warfarin has been on just about every clinician's wish list for the last decade. The direct thrombin inhibitors currently hold the most promise.

Let's keep our fingers crossed that this class of drugs carries the same benefit as warfarin, with far fewer complications and far less monitoring.

Such a breakthrough would have instant impact. Early in my career I struggled with managing hyperlipidemia in my patients until statins appeared. Later, treating depression was a struggle until the SSRIs showed up.

This would be even bigger.

In his book “The Youngest Science,” Dr. Lewis Thomas wrote about promising opportunities in medicine that began developing more than 60 years ago. Those physicians now retired or long passed were astounded when antibiotics first became available and were put into practice.

Perhaps the next generation of practitioners will marvel that so many of us for so long anticoagulated our patients with “rat poison.”

Exciting times are still upon us.

ERIC G. TANGALOS, M.D., is a professor of medicine at the Mayo Clinic in Rochester, Minn. He reports no relevant conflicts of interest.

Dr. Tangalos

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history and requires frequent dose adjustments. Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of VTE in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, showing noninferiority to warfarin for preventing recurrent or fatal VTE. After 6 months, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman reported at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and 1.9% of warfarin patients (HR 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was seen in no patients on dabigatran and three on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University, Hamilton, Ont., and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150-mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing, Dr. Schulman said the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Dr. Schulman suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin, such that 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

The trial results were published simultaneously in the New England Journal of Medicine (2009;361:2342–52 [doi:10.1056/NEJMoa0906598

My Take

Clinicians Eager to Replace Warfarin

A replacement for warfarin has been on just about every clinician's wish list for the last decade. The direct thrombin inhibitors currently hold the most promise.

Let's keep our fingers crossed that this class of drugs carries the same benefit as warfarin, with far fewer complications and far less monitoring.

Such a breakthrough would have instant impact. Early in my career I struggled with managing hyperlipidemia in my patients until statins appeared. Later, treating depression was a struggle until the SSRIs showed up.

This would be even bigger.

In his book “The Youngest Science,” Dr. Lewis Thomas wrote about promising opportunities in medicine that began developing more than 60 years ago. Those physicians now retired or long passed were astounded when antibiotics first became available and were put into practice.

Perhaps the next generation of practitioners will marvel that so many of us for so long anticoagulated our patients with “rat poison.”

Exciting times are still upon us.

ERIC G. TANGALOS, M.D., is a professor of medicine at the Mayo Clinic in Rochester, Minn. He reports no relevant conflicts of interest.

Dr. Tangalos

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12–20 years, revealed that lumbar spine abnormalities are most common in youth with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 97 patients (52%). Disc disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When BMI was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disc disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at the Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of U.S. children, aged 6–11 years, and 18% of U.S. adolescents, aged 12–19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor Dr. Michael Lipton said.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School, Boston, said the findings are worrisome and emphasize the need to stem the rising tide of pediatric obesity.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children. Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents with a BMI greater than the 85th percentile and two with a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain. A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults. The investigators disclosed no relevant conflicts of interest.

Disc disease was identified in 94% of overweight youth with abnormal MRIs.

Source Courtesy Radiological Society of North America

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12–20 years, revealed that lumbar spine abnormalities are most common in youth with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 97 patients (52%). Disc disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When BMI was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disc disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at the Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of U.S. children, aged 6–11 years, and 18% of U.S. adolescents, aged 12–19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor Dr. Michael Lipton said.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School, Boston, said the findings are worrisome and emphasize the need to stem the rising tide of pediatric obesity.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children. Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents with a BMI greater than the 85th percentile and two with a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain. A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults. The investigators disclosed no relevant conflicts of interest.

Disc disease was identified in 94% of overweight youth with abnormal MRIs.

Source Courtesy Radiological Society of North America

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12–20 years, revealed that lumbar spine abnormalities are most common in youth with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 97 patients (52%). Disc disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When BMI was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disc disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at the Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of U.S. children, aged 6–11 years, and 18% of U.S. adolescents, aged 12–19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor Dr. Michael Lipton said.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School, Boston, said the findings are worrisome and emphasize the need to stem the rising tide of pediatric obesity.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children. Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents with a BMI greater than the 85th percentile and two with a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain. A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults. The investigators disclosed no relevant conflicts of interest.

Disc disease was identified in 94% of overweight youth with abnormal MRIs.

Source Courtesy Radiological Society of North America

CHICAGO — The use of elastography, or the ability to measure the stiffness of lesions during ultrasound, may help distinguish benign from malignant breast lesions, suggest results of a study of 193 women.

Elastography correctly identified 98% of lesions that were shown on biopsy to be malignant. With biopsied benign lesions, elastography properly identified 78% of the lesions, Dr. Stamatia V. Destounis, a diagnostic radiologist at a breast imaging and diagnosis center in Rochester, N.Y., reported in a poster at the annual meeting of the Radiological Society of North America.

“The addition of elastography could potentially help decrease the need to perform a biopsy, or could reduce the need for additional imaging of benign lesions, thus reducing the associated patient anxiety,” she told reporters, noting that as many as 20% of young women have breast fibroadenomas.

Elastography software has been available for some time, but is having a resurgence in recent years, particularly in thyroid, prostate, and breast applications as the technology advances and the software is included on new imaging units. The technology can also be applied to a standard unit without an additional upgrade, with the images read side by side, she said at a press briefing during the meeting.

Overall, elasticity imaging increases the specificity of ultrasound by measuring the compressibility and mechanical properties of a lesion. Tumors are typically stiffer than surrounding tissue, whereas cysts have a “bull's eye” appearance on elastography, Dr. Destounis said. Cancerous lesions also tend to be larger than benign findings on elastography.

The study was conducted in 2007–2009 and included 193 patients (average age, 54 years) who underwent elastography at the time of standard breast ultrasound utilizing a Siemens Sonoline Antares or Siemens S2000 ultrasound unit.

A total of 58 lesions did not undergo biopsy and were predetermined to be benign. Biopsies were performed in 140 lesions, of which 59 were cancers, 69 were benign, 1 was an atypical papillary neoplasm, and 11 were cyst aspirations in which fluid was drained and the abnormality resolved.

Of the 140 biopsies, the elastogram image correlated with the standard B-mode ultrasound image in 58 of the 59 cancers (98%). One case was interpreted as benign by elastography, but was a cancer on needle biopsy, said Dr. Destounis, also of the department of imaging sciences at the University of Rochester.

Of the 69 benign findings observed, the elastogram and B-mode ultrasound images correlated in 54 (78%) of cases. Four did not correlate and measured larger on elastography, and 11 cases were unclear, she said.

“Women are becoming more and more concerned about unnecessary procedures and unnecessary needle biopsies and the anxiety that creates,” Dr. Destounis said.

“I think this may be an additional tool, specifically for some of the benign findings like the fibroadenomas in young women or some of the cystic structures that you can really identify with elastography. You have to use your clinical judgment. I'm not using elastography in a vacuum. I'm using it in correlation with everything else.”

Disclosures: Dr. Destounis is a consultant for Carestream Health, an advisory board member for Siemens, and an investigator for Siemens, Fujifilm Holdings, Hologic, and U-Systems.

'The addition of elastography could potentially help decrease the need to perform a biopsy.'

Source DR. DESTOUNIS

Ultrasound reveals the presence of a solid mass in a patient's breast.

A mass that's cancerous appears larger on elastography than on ultrasound.

Ultrasound shows a nodule consistent with this patient's fibroadenoma.

Benign lesions appear smaller on elastography than on ultrasound.

Source Images courtesy Radiological Society of North America

CHICAGO — The use of elastography, or the ability to measure the stiffness of lesions during ultrasound, may help distinguish benign from malignant breast lesions, suggest results of a study of 193 women.

Elastography correctly identified 98% of lesions that were shown on biopsy to be malignant. With biopsied benign lesions, elastography properly identified 78% of the lesions, Dr. Stamatia V. Destounis, a diagnostic radiologist at a breast imaging and diagnosis center in Rochester, N.Y., reported in a poster at the annual meeting of the Radiological Society of North America.

“The addition of elastography could potentially help decrease the need to perform a biopsy, or could reduce the need for additional imaging of benign lesions, thus reducing the associated patient anxiety,” she told reporters, noting that as many as 20% of young women have breast fibroadenomas.

Elastography software has been available for some time, but is having a resurgence in recent years, particularly in thyroid, prostate, and breast applications as the technology advances and the software is included on new imaging units. The technology can also be applied to a standard unit without an additional upgrade, with the images read side by side, she said at a press briefing during the meeting.

Overall, elasticity imaging increases the specificity of ultrasound by measuring the compressibility and mechanical properties of a lesion. Tumors are typically stiffer than surrounding tissue, whereas cysts have a “bull's eye” appearance on elastography, Dr. Destounis said. Cancerous lesions also tend to be larger than benign findings on elastography.

The study was conducted in 2007–2009 and included 193 patients (average age, 54 years) who underwent elastography at the time of standard breast ultrasound utilizing a Siemens Sonoline Antares or Siemens S2000 ultrasound unit.

A total of 58 lesions did not undergo biopsy and were predetermined to be benign. Biopsies were performed in 140 lesions, of which 59 were cancers, 69 were benign, 1 was an atypical papillary neoplasm, and 11 were cyst aspirations in which fluid was drained and the abnormality resolved.

Of the 140 biopsies, the elastogram image correlated with the standard B-mode ultrasound image in 58 of the 59 cancers (98%). One case was interpreted as benign by elastography, but was a cancer on needle biopsy, said Dr. Destounis, also of the department of imaging sciences at the University of Rochester.

Of the 69 benign findings observed, the elastogram and B-mode ultrasound images correlated in 54 (78%) of cases. Four did not correlate and measured larger on elastography, and 11 cases were unclear, she said.

“Women are becoming more and more concerned about unnecessary procedures and unnecessary needle biopsies and the anxiety that creates,” Dr. Destounis said.

“I think this may be an additional tool, specifically for some of the benign findings like the fibroadenomas in young women or some of the cystic structures that you can really identify with elastography. You have to use your clinical judgment. I'm not using elastography in a vacuum. I'm using it in correlation with everything else.”

Disclosures: Dr. Destounis is a consultant for Carestream Health, an advisory board member for Siemens, and an investigator for Siemens, Fujifilm Holdings, Hologic, and U-Systems.

'The addition of elastography could potentially help decrease the need to perform a biopsy.'

Source DR. DESTOUNIS

Ultrasound reveals the presence of a solid mass in a patient's breast.

A mass that's cancerous appears larger on elastography than on ultrasound.

Ultrasound shows a nodule consistent with this patient's fibroadenoma.

Benign lesions appear smaller on elastography than on ultrasound.

Source Images courtesy Radiological Society of North America

CHICAGO — The use of elastography, or the ability to measure the stiffness of lesions during ultrasound, may help distinguish benign from malignant breast lesions, suggest results of a study of 193 women.

Elastography correctly identified 98% of lesions that were shown on biopsy to be malignant. With biopsied benign lesions, elastography properly identified 78% of the lesions, Dr. Stamatia V. Destounis, a diagnostic radiologist at a breast imaging and diagnosis center in Rochester, N.Y., reported in a poster at the annual meeting of the Radiological Society of North America.

“The addition of elastography could potentially help decrease the need to perform a biopsy, or could reduce the need for additional imaging of benign lesions, thus reducing the associated patient anxiety,” she told reporters, noting that as many as 20% of young women have breast fibroadenomas.

Elastography software has been available for some time, but is having a resurgence in recent years, particularly in thyroid, prostate, and breast applications as the technology advances and the software is included on new imaging units. The technology can also be applied to a standard unit without an additional upgrade, with the images read side by side, she said at a press briefing during the meeting.

Overall, elasticity imaging increases the specificity of ultrasound by measuring the compressibility and mechanical properties of a lesion. Tumors are typically stiffer than surrounding tissue, whereas cysts have a “bull's eye” appearance on elastography, Dr. Destounis said. Cancerous lesions also tend to be larger than benign findings on elastography.

The study was conducted in 2007–2009 and included 193 patients (average age, 54 years) who underwent elastography at the time of standard breast ultrasound utilizing a Siemens Sonoline Antares or Siemens S2000 ultrasound unit.

A total of 58 lesions did not undergo biopsy and were predetermined to be benign. Biopsies were performed in 140 lesions, of which 59 were cancers, 69 were benign, 1 was an atypical papillary neoplasm, and 11 were cyst aspirations in which fluid was drained and the abnormality resolved.

Of the 140 biopsies, the elastogram image correlated with the standard B-mode ultrasound image in 58 of the 59 cancers (98%). One case was interpreted as benign by elastography, but was a cancer on needle biopsy, said Dr. Destounis, also of the department of imaging sciences at the University of Rochester.

Of the 69 benign findings observed, the elastogram and B-mode ultrasound images correlated in 54 (78%) of cases. Four did not correlate and measured larger on elastography, and 11 cases were unclear, she said.

“Women are becoming more and more concerned about unnecessary procedures and unnecessary needle biopsies and the anxiety that creates,” Dr. Destounis said.

“I think this may be an additional tool, specifically for some of the benign findings like the fibroadenomas in young women or some of the cystic structures that you can really identify with elastography. You have to use your clinical judgment. I'm not using elastography in a vacuum. I'm using it in correlation with everything else.”

Disclosures: Dr. Destounis is a consultant for Carestream Health, an advisory board member for Siemens, and an investigator for Siemens, Fujifilm Holdings, Hologic, and U-Systems.

'The addition of elastography could potentially help decrease the need to perform a biopsy.'

Source DR. DESTOUNIS

Ultrasound reveals the presence of a solid mass in a patient's breast.

A mass that's cancerous appears larger on elastography than on ultrasound.

Ultrasound shows a nodule consistent with this patient's fibroadenoma.

Benign lesions appear smaller on elastography than on ultrasound.

Source Images courtesy Radiological Society of North America

CHICAGO — Radiation therapy significantly reduced the risk of recurrence in melanoma patients at high risk of relapse after lymphadenectomy, according to a phase III intergroup trial.

Among 217 fully evaluable patients, 68% of patients treated with external beam radiation after surgery had lymph node field recurrence at 2 years, compared with 80% of those observed after surgery. In an intent-to-treat analysis in 248 patients, recurrence rates were 65% vs. 82%, respectively. Median follow-up was 39 months.

Early radiotherapy toxicity appears minimal, Dr. Bryan Burmeister reported on behalf of the Trans Tasman Radiation Oncology Group 02.01/Australia and New Zealand Melanoma Trial Group 01.02 at the annual meeting of the American Society for Radiation Oncology (ASTRO).

“I believe this is the only real advance in the management of melanoma to happen in the last 15 years, since the interferon data came out,” Dr. Burmeister said in a press briefing. He urged physicians to discuss radiation therapy as an option with their melanoma patients.

Dr. Matthew Ballo, who was invited to discuss the results during the plenary presentation, said that the value of adjuvant radiotherapy in melanoma has been debated for years, and that as recently as 2004 it was viewed as a management approach of undetermined potential that should not be considered in routine practice.

“We now have high-level evidence supporting radiation therapy in selected patients with lymph node disease from malignant melanoma,” he said.

He cautioned that the lack of overall survival benefit observed in the trial may impede rapid acceptance of the data. Median survival times were 31 months with radiotherapy and 34 months with observation (P= .14). There were 120 deaths, 2 of which were not melanoma related.

Dr. Ballo suggested that radiologists in the clinical arena stress the importance of regional control, and remind colleagues in the academic arena that improvements in outcome occur in small steps. Relapse rates in patients with high-risk features, such as those in the study, are 30%–50%, he noted.

Patients were eligible if they had involvement of at least one parotid, at least two cervical or axillary, or at least three groin nodes; or extranodal spread; or a minimum metastatic node diameter of 3 cm in the neck or axilla or 4 cm in the groin. Patients randomized to radiation received 48 Gy in 20 fractions. Radiotherapy compliance was 79%.

Grade 3 toxicities 2 weeks post radiation included 18 cases of dermatitis and 2 of pain. At 6 weeks, there were five cases of dermatitis, two of pain, and one of fatigue, said Dr. Burmeister, director of radiation oncology at Princess Alexandra Hospital in Brisbane, Australia. No grade 4 early toxicities were reported.

Longer-term results are needed to assess fibrosis, lymphedema, and brachial plexopathy, as well as recurrence-related morbidity in the control arm, said Dr. Ballo, head of radiation oncology at the M.D. Anderson Clinical Care Center in Nassau Bay, Tex.

'I believe this is the only real advance in the management of melanoma to happen in the last 15 years.'

Source DR. BURMEISTER

Vitals

Major Finding: Radiation therapy after lymphadenectomy reduces melanoma recurrence in patients at high risk.

Source of Data: Phase III intergroup trial of 217 fully evaluable patients.

Disclosures: The study was supported by the Australia and New Zealand Melanoma Trial Group, National Health and Medical Research Council of Australia, and Cancer Council Victoria. Dr. Burmeister and Dr. Ballo reported no conflicts of interest.

CHICAGO — Radiation therapy significantly reduced the risk of recurrence in melanoma patients at high risk of relapse after lymphadenectomy, according to a phase III intergroup trial.

Among 217 fully evaluable patients, 68% of patients treated with external beam radiation after surgery had lymph node field recurrence at 2 years, compared with 80% of those observed after surgery. In an intent-to-treat analysis in 248 patients, recurrence rates were 65% vs. 82%, respectively. Median follow-up was 39 months.

Early radiotherapy toxicity appears minimal, Dr. Bryan Burmeister reported on behalf of the Trans Tasman Radiation Oncology Group 02.01/Australia and New Zealand Melanoma Trial Group 01.02 at the annual meeting of the American Society for Radiation Oncology (ASTRO).

“I believe this is the only real advance in the management of melanoma to happen in the last 15 years, since the interferon data came out,” Dr. Burmeister said in a press briefing. He urged physicians to discuss radiation therapy as an option with their melanoma patients.

Dr. Matthew Ballo, who was invited to discuss the results during the plenary presentation, said that the value of adjuvant radiotherapy in melanoma has been debated for years, and that as recently as 2004 it was viewed as a management approach of undetermined potential that should not be considered in routine practice.

“We now have high-level evidence supporting radiation therapy in selected patients with lymph node disease from malignant melanoma,” he said.

He cautioned that the lack of overall survival benefit observed in the trial may impede rapid acceptance of the data. Median survival times were 31 months with radiotherapy and 34 months with observation (P= .14). There were 120 deaths, 2 of which were not melanoma related.

Dr. Ballo suggested that radiologists in the clinical arena stress the importance of regional control, and remind colleagues in the academic arena that improvements in outcome occur in small steps. Relapse rates in patients with high-risk features, such as those in the study, are 30%–50%, he noted.

Patients were eligible if they had involvement of at least one parotid, at least two cervical or axillary, or at least three groin nodes; or extranodal spread; or a minimum metastatic node diameter of 3 cm in the neck or axilla or 4 cm in the groin. Patients randomized to radiation received 48 Gy in 20 fractions. Radiotherapy compliance was 79%.

Grade 3 toxicities 2 weeks post radiation included 18 cases of dermatitis and 2 of pain. At 6 weeks, there were five cases of dermatitis, two of pain, and one of fatigue, said Dr. Burmeister, director of radiation oncology at Princess Alexandra Hospital in Brisbane, Australia. No grade 4 early toxicities were reported.

Longer-term results are needed to assess fibrosis, lymphedema, and brachial plexopathy, as well as recurrence-related morbidity in the control arm, said Dr. Ballo, head of radiation oncology at the M.D. Anderson Clinical Care Center in Nassau Bay, Tex.

'I believe this is the only real advance in the management of melanoma to happen in the last 15 years.'

Source DR. BURMEISTER

Vitals

Major Finding: Radiation therapy after lymphadenectomy reduces melanoma recurrence in patients at high risk.

Source of Data: Phase III intergroup trial of 217 fully evaluable patients.

Disclosures: The study was supported by the Australia and New Zealand Melanoma Trial Group, National Health and Medical Research Council of Australia, and Cancer Council Victoria. Dr. Burmeister and Dr. Ballo reported no conflicts of interest.

CHICAGO — Radiation therapy significantly reduced the risk of recurrence in melanoma patients at high risk of relapse after lymphadenectomy, according to a phase III intergroup trial.

Among 217 fully evaluable patients, 68% of patients treated with external beam radiation after surgery had lymph node field recurrence at 2 years, compared with 80% of those observed after surgery. In an intent-to-treat analysis in 248 patients, recurrence rates were 65% vs. 82%, respectively. Median follow-up was 39 months.

Early radiotherapy toxicity appears minimal, Dr. Bryan Burmeister reported on behalf of the Trans Tasman Radiation Oncology Group 02.01/Australia and New Zealand Melanoma Trial Group 01.02 at the annual meeting of the American Society for Radiation Oncology (ASTRO).

“I believe this is the only real advance in the management of melanoma to happen in the last 15 years, since the interferon data came out,” Dr. Burmeister said in a press briefing. He urged physicians to discuss radiation therapy as an option with their melanoma patients.

Dr. Matthew Ballo, who was invited to discuss the results during the plenary presentation, said that the value of adjuvant radiotherapy in melanoma has been debated for years, and that as recently as 2004 it was viewed as a management approach of undetermined potential that should not be considered in routine practice.

“We now have high-level evidence supporting radiation therapy in selected patients with lymph node disease from malignant melanoma,” he said.

He cautioned that the lack of overall survival benefit observed in the trial may impede rapid acceptance of the data. Median survival times were 31 months with radiotherapy and 34 months with observation (P= .14). There were 120 deaths, 2 of which were not melanoma related.

Dr. Ballo suggested that radiologists in the clinical arena stress the importance of regional control, and remind colleagues in the academic arena that improvements in outcome occur in small steps. Relapse rates in patients with high-risk features, such as those in the study, are 30%–50%, he noted.

Patients were eligible if they had involvement of at least one parotid, at least two cervical or axillary, or at least three groin nodes; or extranodal spread; or a minimum metastatic node diameter of 3 cm in the neck or axilla or 4 cm in the groin. Patients randomized to radiation received 48 Gy in 20 fractions. Radiotherapy compliance was 79%.

Grade 3 toxicities 2 weeks post radiation included 18 cases of dermatitis and 2 of pain. At 6 weeks, there were five cases of dermatitis, two of pain, and one of fatigue, said Dr. Burmeister, director of radiation oncology at Princess Alexandra Hospital in Brisbane, Australia. No grade 4 early toxicities were reported.

Longer-term results are needed to assess fibrosis, lymphedema, and brachial plexopathy, as well as recurrence-related morbidity in the control arm, said Dr. Ballo, head of radiation oncology at the M.D. Anderson Clinical Care Center in Nassau Bay, Tex.

'I believe this is the only real advance in the management of melanoma to happen in the last 15 years.'

Source DR. BURMEISTER

Vitals

Major Finding: Radiation therapy after lymphadenectomy reduces melanoma recurrence in patients at high risk.

Source of Data: Phase III intergroup trial of 217 fully evaluable patients.

Disclosures: The study was supported by the Australia and New Zealand Melanoma Trial Group, National Health and Medical Research Council of Australia, and Cancer Council Victoria. Dr. Burmeister and Dr. Ballo reported no conflicts of interest.

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases (P value equal .0007), Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said.

“We believe it has tremendous promise to reduce unnecessary biopsies,” he added.

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared with benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said. “That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society meeting in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'there is no other way.'”

She suggested transitioning this technology from radiology to clinical dermatology would not be difficult nor take long because of need and the rising incidence and economic impact of skin cancer. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

An elastogram (left) and ultrasound (right) show squamous cell carcinoma of the skin. The technique could eliminate unnecessary biopsies of benign skin lesions.

Source Courtesy Radiological Society of North America

The information gleaned could rival 'information that a pathologist would see after the lesion was excised.'

Source DR. SIEGEL

'A couple of clinical dermatologists said, “there is no other way.”'

Source DR. DASGEB

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases (P value equal .0007), Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said.

“We believe it has tremendous promise to reduce unnecessary biopsies,” he added.

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared with benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said. “That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society meeting in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'there is no other way.'”

She suggested transitioning this technology from radiology to clinical dermatology would not be difficult nor take long because of need and the rising incidence and economic impact of skin cancer. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

An elastogram (left) and ultrasound (right) show squamous cell carcinoma of the skin. The technique could eliminate unnecessary biopsies of benign skin lesions.

Source Courtesy Radiological Society of North America

The information gleaned could rival 'information that a pathologist would see after the lesion was excised.'

Source DR. SIEGEL

'A couple of clinical dermatologists said, “there is no other way.”'

Source DR. DASGEB

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases (P value equal .0007), Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said.

“We believe it has tremendous promise to reduce unnecessary biopsies,” he added.

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared with benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said. “That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society meeting in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'there is no other way.'”

She suggested transitioning this technology from radiology to clinical dermatology would not be difficult nor take long because of need and the rising incidence and economic impact of skin cancer. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

An elastogram (left) and ultrasound (right) show squamous cell carcinoma of the skin. The technique could eliminate unnecessary biopsies of benign skin lesions.

Source Courtesy Radiological Society of North America

The information gleaned could rival 'information that a pathologist would see after the lesion was excised.'

Source DR. SIEGEL

'A couple of clinical dermatologists said, “there is no other way.”'

Source DR. DASGEB

BERLIN — Denosumab was superior to zoledronic acid in the treatment of bone metastases in advanced breast cancer, but not so in the treatment of multiple myeloma or select solid tumors, according to data from two phase III trials.

The trials—Denosumab 136 and Denosumab 244—were presented at the joint congress of the European Cancer Organization and the European Society for Medical Oncology.

Dr. Alison Stopeck, who led the Denosumab 136 study in breast cancer, told reporters at an Amgen-sponsored press briefing that denosumab is clearly a first-line therapy.

In the Denosumab 136 trial, denosumab was superior to zoledronic acid in delaying the time to a first on-study skeletal-related event (SRE), defined as fracture, spinal cord compression, or radiation or surgery to bone. In all, 2,046 advanced breast cancer patients with bone metastases were studied. The median time to first SRE was not reached for denosumab, and was 26.5 months for zoledronic acid, said Dr. Stopeck, director of the clinical breast cancer program at the University of Arizona, Tucson.

Denosumab also significantly delayed the time to first and subsequent SREs, with 474 events reported in the denosumab arm and 608 in the zoledronic acid arm.

Renal failure occurred significantly more often in patients treated with zoledronic acid than denosumab (25 vs. 2 patients), as did acute renal failure (7 vs. 1 patient).

In the Denosumab 244 trial, the median time to first on-study SRE was 20.6 months for denosumab and 16.3 months for zoledronic acid among 1,776 advanced cancer patients with multiple myeloma or solid tumors, excluding breast and prostate cancer, a nonsignificant difference, reported lead author Dr. David Henry.

There were 392 first and subsequent SREs with denosumab vs. 436 such events with zoledronic acid, but again the difference was not significant, said Dr. Henry, a hematologist/oncologist at the Pennsylvania Hospital in Philadelphia.

Renal failure occurred in 25 of the 878 patients in the zoledronic acid group and in 20 of the 878 patients in the denosumab group. Acute renal failure was seen in 16 vs. 11 patients, respectively.

The Food and Drug Administration is expected to announce an approval decision on denosumab for the treatment of osteoporosis soon.

Both trials were supported by Amgen. Dr. Stopeck disclosed financial relationships with Novartis and Amgen. Dr. Henry disclosed relationships with Amgen, Ortho-Biotech Products LP, and Watson Pharmaceuticals Inc.

Compared with zoledronic acid, denosumab delayed time to first on-study SRE, but not significantly.

Source DR. HENRY

BERLIN — Denosumab was superior to zoledronic acid in the treatment of bone metastases in advanced breast cancer, but not so in the treatment of multiple myeloma or select solid tumors, according to data from two phase III trials.

The trials—Denosumab 136 and Denosumab 244—were presented at the joint congress of the European Cancer Organization and the European Society for Medical Oncology.

Dr. Alison Stopeck, who led the Denosumab 136 study in breast cancer, told reporters at an Amgen-sponsored press briefing that denosumab is clearly a first-line therapy.

In the Denosumab 136 trial, denosumab was superior to zoledronic acid in delaying the time to a first on-study skeletal-related event (SRE), defined as fracture, spinal cord compression, or radiation or surgery to bone. In all, 2,046 advanced breast cancer patients with bone metastases were studied. The median time to first SRE was not reached for denosumab, and was 26.5 months for zoledronic acid, said Dr. Stopeck, director of the clinical breast cancer program at the University of Arizona, Tucson.

Denosumab also significantly delayed the time to first and subsequent SREs, with 474 events reported in the denosumab arm and 608 in the zoledronic acid arm.

Renal failure occurred significantly more often in patients treated with zoledronic acid than denosumab (25 vs. 2 patients), as did acute renal failure (7 vs. 1 patient).

In the Denosumab 244 trial, the median time to first on-study SRE was 20.6 months for denosumab and 16.3 months for zoledronic acid among 1,776 advanced cancer patients with multiple myeloma or solid tumors, excluding breast and prostate cancer, a nonsignificant difference, reported lead author Dr. David Henry.

There were 392 first and subsequent SREs with denosumab vs. 436 such events with zoledronic acid, but again the difference was not significant, said Dr. Henry, a hematologist/oncologist at the Pennsylvania Hospital in Philadelphia.

Renal failure occurred in 25 of the 878 patients in the zoledronic acid group and in 20 of the 878 patients in the denosumab group. Acute renal failure was seen in 16 vs. 11 patients, respectively.

The Food and Drug Administration is expected to announce an approval decision on denosumab for the treatment of osteoporosis soon.

Both trials were supported by Amgen. Dr. Stopeck disclosed financial relationships with Novartis and Amgen. Dr. Henry disclosed relationships with Amgen, Ortho-Biotech Products LP, and Watson Pharmaceuticals Inc.

Compared with zoledronic acid, denosumab delayed time to first on-study SRE, but not significantly.

Source DR. HENRY

BERLIN — Denosumab was superior to zoledronic acid in the treatment of bone metastases in advanced breast cancer, but not so in the treatment of multiple myeloma or select solid tumors, according to data from two phase III trials.

The trials—Denosumab 136 and Denosumab 244—were presented at the joint congress of the European Cancer Organization and the European Society for Medical Oncology.

Dr. Alison Stopeck, who led the Denosumab 136 study in breast cancer, told reporters at an Amgen-sponsored press briefing that denosumab is clearly a first-line therapy.

In the Denosumab 136 trial, denosumab was superior to zoledronic acid in delaying the time to a first on-study skeletal-related event (SRE), defined as fracture, spinal cord compression, or radiation or surgery to bone. In all, 2,046 advanced breast cancer patients with bone metastases were studied. The median time to first SRE was not reached for denosumab, and was 26.5 months for zoledronic acid, said Dr. Stopeck, director of the clinical breast cancer program at the University of Arizona, Tucson.

Denosumab also significantly delayed the time to first and subsequent SREs, with 474 events reported in the denosumab arm and 608 in the zoledronic acid arm.

Renal failure occurred significantly more often in patients treated with zoledronic acid than denosumab (25 vs. 2 patients), as did acute renal failure (7 vs. 1 patient).

In the Denosumab 244 trial, the median time to first on-study SRE was 20.6 months for denosumab and 16.3 months for zoledronic acid among 1,776 advanced cancer patients with multiple myeloma or solid tumors, excluding breast and prostate cancer, a nonsignificant difference, reported lead author Dr. David Henry.

There were 392 first and subsequent SREs with denosumab vs. 436 such events with zoledronic acid, but again the difference was not significant, said Dr. Henry, a hematologist/oncologist at the Pennsylvania Hospital in Philadelphia.

Renal failure occurred in 25 of the 878 patients in the zoledronic acid group and in 20 of the 878 patients in the denosumab group. Acute renal failure was seen in 16 vs. 11 patients, respectively.

The Food and Drug Administration is expected to announce an approval decision on denosumab for the treatment of osteoporosis soon.

Both trials were supported by Amgen. Dr. Stopeck disclosed financial relationships with Novartis and Amgen. Dr. Henry disclosed relationships with Amgen, Ortho-Biotech Products LP, and Watson Pharmaceuticals Inc.

Compared with zoledronic acid, denosumab delayed time to first on-study SRE, but not significantly.

Source DR. HENRY

CHICAGO — Electrically stimulating the swallowing apparatus at the back of the throat improves swallow function and speeds the recovery of normal feeding in patients with dysphagia following stroke, according to a small, randomized trial.

Dysphagia is common after stroke and is a risk factor for disruption of normal eating patterns, need for artificial feeding, and aspiration pneumonia. Patients with dysphagia can require frequent hospitalizations for pneumonia, prolonged hospital stays, and increased need for institutionalized care.

The management of dysphagia has thus far failed to provide reliable, effective rehabilitation for these patients, according to Dr. Vanoo Jayasekeran, a clinical research fellow and GI specialist at the School of Translational Medicine, University of Manchester, United Kingdom. However, pharyngeal electrical stimulation (PES) has been shown in stroke patients to enhance cortical excitability of swallowing pathways (Gastroenterology 1998;115:1104-12) and to induce changes in the motor cortex that mimic natural recovery of dysphagia (Neuron 2002;34:831-40).

Dr. Jayasekeran and his colleagues randomly allocated 26 dysphagic stroke patients, mean age 75 years, to PES delivered via a custom-made intraluminal indwelling pharyngeal catheter or sham stimulation via an in situ catheter with no current. The PES group received the treatment for 10 minutes at 5 Hz for 3 consecutive days. At baseline, patients had a mean score on the National Institutes of Health Stroke Survey of 10 and a Penetration-Aspiration Scale (PA) score of 3 or more on an 8-point scale.

PES was associated with a significant reduction in mean cumulative PA scores 2 weeks post-treatment, with a 16% improvement in cumulative PA scores from baseline in the PES group and an 11% deterioration in the sham group, the authors reported in a poster at a meeting on neurogastroenterology and motility.

The PES group also had a significant reduction of abnormal swallows, as indicated by fewer PA scores greater than 3. The University of Manchester provided support for the current study. The investigators reported no conflicts of interest.

Electrical stimulation is provided with an indwelling pharyngeal catheter.

Source Courtesy Dr. Vanoo Jayasekeran

CHICAGO — Electrically stimulating the swallowing apparatus at the back of the throat improves swallow function and speeds the recovery of normal feeding in patients with dysphagia following stroke, according to a small, randomized trial.

Dysphagia is common after stroke and is a risk factor for disruption of normal eating patterns, need for artificial feeding, and aspiration pneumonia. Patients with dysphagia can require frequent hospitalizations for pneumonia, prolonged hospital stays, and increased need for institutionalized care.

The management of dysphagia has thus far failed to provide reliable, effective rehabilitation for these patients, according to Dr. Vanoo Jayasekeran, a clinical research fellow and GI specialist at the School of Translational Medicine, University of Manchester, United Kingdom. However, pharyngeal electrical stimulation (PES) has been shown in stroke patients to enhance cortical excitability of swallowing pathways (Gastroenterology 1998;115:1104-12) and to induce changes in the motor cortex that mimic natural recovery of dysphagia (Neuron 2002;34:831-40).

Dr. Jayasekeran and his colleagues randomly allocated 26 dysphagic stroke patients, mean age 75 years, to PES delivered via a custom-made intraluminal indwelling pharyngeal catheter or sham stimulation via an in situ catheter with no current. The PES group received the treatment for 10 minutes at 5 Hz for 3 consecutive days. At baseline, patients had a mean score on the National Institutes of Health Stroke Survey of 10 and a Penetration-Aspiration Scale (PA) score of 3 or more on an 8-point scale.

PES was associated with a significant reduction in mean cumulative PA scores 2 weeks post-treatment, with a 16% improvement in cumulative PA scores from baseline in the PES group and an 11% deterioration in the sham group, the authors reported in a poster at a meeting on neurogastroenterology and motility.

The PES group also had a significant reduction of abnormal swallows, as indicated by fewer PA scores greater than 3. The University of Manchester provided support for the current study. The investigators reported no conflicts of interest.

Electrical stimulation is provided with an indwelling pharyngeal catheter.

Source Courtesy Dr. Vanoo Jayasekeran

CHICAGO — Electrically stimulating the swallowing apparatus at the back of the throat improves swallow function and speeds the recovery of normal feeding in patients with dysphagia following stroke, according to a small, randomized trial.

Dysphagia is common after stroke and is a risk factor for disruption of normal eating patterns, need for artificial feeding, and aspiration pneumonia. Patients with dysphagia can require frequent hospitalizations for pneumonia, prolonged hospital stays, and increased need for institutionalized care.

The management of dysphagia has thus far failed to provide reliable, effective rehabilitation for these patients, according to Dr. Vanoo Jayasekeran, a clinical research fellow and GI specialist at the School of Translational Medicine, University of Manchester, United Kingdom. However, pharyngeal electrical stimulation (PES) has been shown in stroke patients to enhance cortical excitability of swallowing pathways (Gastroenterology 1998;115:1104-12) and to induce changes in the motor cortex that mimic natural recovery of dysphagia (Neuron 2002;34:831-40).

Dr. Jayasekeran and his colleagues randomly allocated 26 dysphagic stroke patients, mean age 75 years, to PES delivered via a custom-made intraluminal indwelling pharyngeal catheter or sham stimulation via an in situ catheter with no current. The PES group received the treatment for 10 minutes at 5 Hz for 3 consecutive days. At baseline, patients had a mean score on the National Institutes of Health Stroke Survey of 10 and a Penetration-Aspiration Scale (PA) score of 3 or more on an 8-point scale.

PES was associated with a significant reduction in mean cumulative PA scores 2 weeks post-treatment, with a 16% improvement in cumulative PA scores from baseline in the PES group and an 11% deterioration in the sham group, the authors reported in a poster at a meeting on neurogastroenterology and motility.

The PES group also had a significant reduction of abnormal swallows, as indicated by fewer PA scores greater than 3. The University of Manchester provided support for the current study. The investigators reported no conflicts of interest.

Electrical stimulation is provided with an indwelling pharyngeal catheter.

Source Courtesy Dr. Vanoo Jayasekeran

CHICAGO — Combined treatment with hormone therapy and radiation significantly improved several survival end points for men with high-risk prostate cancer in a phase III trial.

Among the adults who received androgen deprivation therapy and radiation, 75% were alive at 5 years, compared with 59% of the patients who received androgen deprivation therapy alone (P = .03).

The actuarial 5-year cause-specific survival was 83% versus 70% (P = .01), respectively, Dr. Piotr Milecki and his associates reported at the annual meeting of the American Society for Radiation Oncology.

Actuarial 5-year biochemical progression-free survival was more than double at 50% with combination therapy vs. 22% with hormone therapy alone (P = .001), whereas distant metastases–free survival was also significantly improved, at 79% vs. 54% (P = .007).

The data are highly relevant because the use of hormone therapy, while still low, is increasing, said Dr. Milecki, who is head of the department of radiotherapy at the Greater Poland Cancer Centre in Poznan.

A prospective population-based study involving older American men found that widespread detection and aggressive treatment for prostate cancer in the United States has led to more androgen deprivation therapy (BJU Int. 2006;98:973-8)

In addition, many urologists do not believe that the addition of radiotherapy will change outcomes in men who are at high risk.

According to a published report, just 30% of the delegates of the European Association of Urology agreed with the EAU's recommendation to use radiotherapy in combination with adjuvant hormone therapy for men with T3-T4 prostate cancer, whereas 48% said that they would prescribe LHRH agonist monotherapy (Eur. Urol. Suppl. 2006;5:S359-96)

The current study enrolled men (aged 51-76 years) with at least one of the following high-risk factors: prostate-specific antigen levels greater than 20 ng/mL, a Gleason score greater than 7, and T3 disease.

Hormone therapy consisted of the LHRH agonist goserelin acetate (Zoladex) as a 1-month, 3.6-mg depot formulation and then a 3-month, 11.8-mg depot plus a leuprolide acetate (Lupron) depot of 7.5 mg per vial for 1 month and of 22.5 mg per vial every 3 months, Dr. Milecki said.

When combined with three-dimensional conformal radiotherapy, the same hormone regimen was started at least 2 months before radiation and then administered in an adjuvant fashion for a minimum of 24 months. The total radiation dose was 46 Gy to the whole pelvis or 70-74 Gy to the prostate and seminal vesicles.

Late toxicity from radiotherapy was moderate, with grade 3 toxicity reported in only four patients, Dr. Milecki said at the meeting.

Gastrointestinal toxicity was 45% with grade 1, 24% with grade 2, and 1% with grade 3, whereas genitourinary toxicity was 43%, 21%, and 1%, respectively. Overall quality of life was not significantly different between the two groups, although diarrhea and fatigue were more pronounced after 4 years in the combined-therapy group, he said.

Dr. Milecki reported that he had no conflicts of interest or outside study sponsorship.

CHICAGO — Combined treatment with hormone therapy and radiation significantly improved several survival end points for men with high-risk prostate cancer in a phase III trial.

Among the adults who received androgen deprivation therapy and radiation, 75% were alive at 5 years, compared with 59% of the patients who received androgen deprivation therapy alone (P = .03).

The actuarial 5-year cause-specific survival was 83% versus 70% (P = .01), respectively, Dr. Piotr Milecki and his associates reported at the annual meeting of the American Society for Radiation Oncology.

Actuarial 5-year biochemical progression-free survival was more than double at 50% with combination therapy vs. 22% with hormone therapy alone (P = .001), whereas distant metastases–free survival was also significantly improved, at 79% vs. 54% (P = .007).

The data are highly relevant because the use of hormone therapy, while still low, is increasing, said Dr. Milecki, who is head of the department of radiotherapy at the Greater Poland Cancer Centre in Poznan.

A prospective population-based study involving older American men found that widespread detection and aggressive treatment for prostate cancer in the United States has led to more androgen deprivation therapy (BJU Int. 2006;98:973-8)

In addition, many urologists do not believe that the addition of radiotherapy will change outcomes in men who are at high risk.

According to a published report, just 30% of the delegates of the European Association of Urology agreed with the EAU's recommendation to use radiotherapy in combination with adjuvant hormone therapy for men with T3-T4 prostate cancer, whereas 48% said that they would prescribe LHRH agonist monotherapy (Eur. Urol. Suppl. 2006;5:S359-96)

The current study enrolled men (aged 51-76 years) with at least one of the following high-risk factors: prostate-specific antigen levels greater than 20 ng/mL, a Gleason score greater than 7, and T3 disease.

Hormone therapy consisted of the LHRH agonist goserelin acetate (Zoladex) as a 1-month, 3.6-mg depot formulation and then a 3-month, 11.8-mg depot plus a leuprolide acetate (Lupron) depot of 7.5 mg per vial for 1 month and of 22.5 mg per vial every 3 months, Dr. Milecki said.

When combined with three-dimensional conformal radiotherapy, the same hormone regimen was started at least 2 months before radiation and then administered in an adjuvant fashion for a minimum of 24 months. The total radiation dose was 46 Gy to the whole pelvis or 70-74 Gy to the prostate and seminal vesicles.

Late toxicity from radiotherapy was moderate, with grade 3 toxicity reported in only four patients, Dr. Milecki said at the meeting.

Gastrointestinal toxicity was 45% with grade 1, 24% with grade 2, and 1% with grade 3, whereas genitourinary toxicity was 43%, 21%, and 1%, respectively. Overall quality of life was not significantly different between the two groups, although diarrhea and fatigue were more pronounced after 4 years in the combined-therapy group, he said.

Dr. Milecki reported that he had no conflicts of interest or outside study sponsorship.

CHICAGO — Combined treatment with hormone therapy and radiation significantly improved several survival end points for men with high-risk prostate cancer in a phase III trial.

Among the adults who received androgen deprivation therapy and radiation, 75% were alive at 5 years, compared with 59% of the patients who received androgen deprivation therapy alone (P = .03).

The actuarial 5-year cause-specific survival was 83% versus 70% (P = .01), respectively, Dr. Piotr Milecki and his associates reported at the annual meeting of the American Society for Radiation Oncology.

Actuarial 5-year biochemical progression-free survival was more than double at 50% with combination therapy vs. 22% with hormone therapy alone (P = .001), whereas distant metastases–free survival was also significantly improved, at 79% vs. 54% (P = .007).

The data are highly relevant because the use of hormone therapy, while still low, is increasing, said Dr. Milecki, who is head of the department of radiotherapy at the Greater Poland Cancer Centre in Poznan.

A prospective population-based study involving older American men found that widespread detection and aggressive treatment for prostate cancer in the United States has led to more androgen deprivation therapy (BJU Int. 2006;98:973-8)

In addition, many urologists do not believe that the addition of radiotherapy will change outcomes in men who are at high risk.

According to a published report, just 30% of the delegates of the European Association of Urology agreed with the EAU's recommendation to use radiotherapy in combination with adjuvant hormone therapy for men with T3-T4 prostate cancer, whereas 48% said that they would prescribe LHRH agonist monotherapy (Eur. Urol. Suppl. 2006;5:S359-96)

The current study enrolled men (aged 51-76 years) with at least one of the following high-risk factors: prostate-specific antigen levels greater than 20 ng/mL, a Gleason score greater than 7, and T3 disease.

Hormone therapy consisted of the LHRH agonist goserelin acetate (Zoladex) as a 1-month, 3.6-mg depot formulation and then a 3-month, 11.8-mg depot plus a leuprolide acetate (Lupron) depot of 7.5 mg per vial for 1 month and of 22.5 mg per vial every 3 months, Dr. Milecki said.

When combined with three-dimensional conformal radiotherapy, the same hormone regimen was started at least 2 months before radiation and then administered in an adjuvant fashion for a minimum of 24 months. The total radiation dose was 46 Gy to the whole pelvis or 70-74 Gy to the prostate and seminal vesicles.

Late toxicity from radiotherapy was moderate, with grade 3 toxicity reported in only four patients, Dr. Milecki said at the meeting.

Gastrointestinal toxicity was 45% with grade 1, 24% with grade 2, and 1% with grade 3, whereas genitourinary toxicity was 43%, 21%, and 1%, respectively. Overall quality of life was not significantly different between the two groups, although diarrhea and fatigue were more pronounced after 4 years in the combined-therapy group, he said.

Dr. Milecki reported that he had no conflicts of interest or outside study sponsorship.

CHICAGO — Patients undergoing abdominal/pelvic computed tomography frequently receive unindicated additional scans, resulting in excess radiation exposure, a review of 978 CT scans suggests.

The review, which included exams done in 500 patients, revealed that 263 exams (52.6% of the total) were not indicated based on American College of Radiology Appropriateness Criteria. The exams, performed at institutions in Illinois, Michigan, Minnesota, and Wisconsin, involved patients aged 9 months to 91 years.

One in five patients received at least 50 millisieverts (mSv) of radiation in a single examination. Seven (1.4%) of the 500 patients received greater than 100 mSv—a dose that is associated with an increased cancer risk. The mean radiation dose per patient was 32.9 mSv, which is equivalent to the dose from about 1,000 chest X-rays. The 308 exams that consisted of multiple phases exposed patients to a mean dose of 43 mSv, Dr. Kristie Guite reported at the annual meeting of the Radiological Society of North America.

Radiologists are encouraged to follow the standard of “As Low as Reasonably Achievable” or ALARA, noted Dr. Guite, a resident at the University of Wisconsin, Madison. “The most important finding in this study is that adherence to ALARA is not widespread at this time,” she said at a press briefing during the meeting.

“At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer,” she said. If the data are extrapolated to all CT scans of the abdomen/pelvis performed in the United States, “this would lead to 23,000 radiation-induced cancer cases per year.”

As for why radiologists may order extra scans, coauthor Dr. J. Louis Hinshaw, also with the UW-Madison, said it may be that radiologists simply have the ability and tools available to perform the tests. Also, protocols are set up on CT scanners beforehand and are often designed to answer “what if” scenarios, in which additional views may be needed. “There is some risk-aversion that comes into play,” he said at the briefing.

Of the 500 patients, 7% had findings that would not have been identified without the extra scans, but most of these were not clinically relevant, Dr. Hinshaw said.

The Radiological Society of North America has partnered with the American College of Radiology to create a task force on adult radiation protection to increase awareness of cumulative dose and radiation risks.

Both researchers stressed that CT is a valuable diagnostic tool and that the study findings should not impede use of the technology.

Press briefing moderator Dr. Robert Zimmerman, professor of radiology at Weill Cornell Medical College in New York, concurred. He suggested that patients investigate the radiation protocol at their institution and ask their physicians what steps are being taken to minimize radiation dose.

“We don't want to damage patients, but we know we have the technology that is very useful in saving people's lives,” Dr. Zimmerman said. “We are trying to balance the two.”

In the current study, patients with a malignancy were 22% more likely to receive excess radiation, Dr. Guite said.

Delayed-phase imaging, performed after a contrast agent has accumulated in the kidneys/bladder, accounted for 77% of the unnecessary scans.

There was no study sponsorship, but one coauthor disclosed being a stock holder with NeuWave Medical Inc. and a patent holder with Covidien AG.

'At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer.'

Source DR. GUITE

CHICAGO — Patients undergoing abdominal/pelvic computed tomography frequently receive unindicated additional scans, resulting in excess radiation exposure, a review of 978 CT scans suggests.

The review, which included exams done in 500 patients, revealed that 263 exams (52.6% of the total) were not indicated based on American College of Radiology Appropriateness Criteria. The exams, performed at institutions in Illinois, Michigan, Minnesota, and Wisconsin, involved patients aged 9 months to 91 years.

One in five patients received at least 50 millisieverts (mSv) of radiation in a single examination. Seven (1.4%) of the 500 patients received greater than 100 mSv—a dose that is associated with an increased cancer risk. The mean radiation dose per patient was 32.9 mSv, which is equivalent to the dose from about 1,000 chest X-rays. The 308 exams that consisted of multiple phases exposed patients to a mean dose of 43 mSv, Dr. Kristie Guite reported at the annual meeting of the Radiological Society of North America.

Radiologists are encouraged to follow the standard of “As Low as Reasonably Achievable” or ALARA, noted Dr. Guite, a resident at the University of Wisconsin, Madison. “The most important finding in this study is that adherence to ALARA is not widespread at this time,” she said at a press briefing during the meeting.

“At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer,” she said. If the data are extrapolated to all CT scans of the abdomen/pelvis performed in the United States, “this would lead to 23,000 radiation-induced cancer cases per year.”

As for why radiologists may order extra scans, coauthor Dr. J. Louis Hinshaw, also with the UW-Madison, said it may be that radiologists simply have the ability and tools available to perform the tests. Also, protocols are set up on CT scanners beforehand and are often designed to answer “what if” scenarios, in which additional views may be needed. “There is some risk-aversion that comes into play,” he said at the briefing.

Of the 500 patients, 7% had findings that would not have been identified without the extra scans, but most of these were not clinically relevant, Dr. Hinshaw said.

The Radiological Society of North America has partnered with the American College of Radiology to create a task force on adult radiation protection to increase awareness of cumulative dose and radiation risks.

Both researchers stressed that CT is a valuable diagnostic tool and that the study findings should not impede use of the technology.

Press briefing moderator Dr. Robert Zimmerman, professor of radiology at Weill Cornell Medical College in New York, concurred. He suggested that patients investigate the radiation protocol at their institution and ask their physicians what steps are being taken to minimize radiation dose.

“We don't want to damage patients, but we know we have the technology that is very useful in saving people's lives,” Dr. Zimmerman said. “We are trying to balance the two.”

In the current study, patients with a malignancy were 22% more likely to receive excess radiation, Dr. Guite said.

Delayed-phase imaging, performed after a contrast agent has accumulated in the kidneys/bladder, accounted for 77% of the unnecessary scans.

There was no study sponsorship, but one coauthor disclosed being a stock holder with NeuWave Medical Inc. and a patent holder with Covidien AG.

'At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer.'

Source DR. GUITE

CHICAGO — Patients undergoing abdominal/pelvic computed tomography frequently receive unindicated additional scans, resulting in excess radiation exposure, a review of 978 CT scans suggests.

The review, which included exams done in 500 patients, revealed that 263 exams (52.6% of the total) were not indicated based on American College of Radiology Appropriateness Criteria. The exams, performed at institutions in Illinois, Michigan, Minnesota, and Wisconsin, involved patients aged 9 months to 91 years.

One in five patients received at least 50 millisieverts (mSv) of radiation in a single examination. Seven (1.4%) of the 500 patients received greater than 100 mSv—a dose that is associated with an increased cancer risk. The mean radiation dose per patient was 32.9 mSv, which is equivalent to the dose from about 1,000 chest X-rays. The 308 exams that consisted of multiple phases exposed patients to a mean dose of 43 mSv, Dr. Kristie Guite reported at the annual meeting of the Radiological Society of North America.

Radiologists are encouraged to follow the standard of “As Low as Reasonably Achievable” or ALARA, noted Dr. Guite, a resident at the University of Wisconsin, Madison. “The most important finding in this study is that adherence to ALARA is not widespread at this time,” she said at a press briefing during the meeting.

“At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer,” she said. If the data are extrapolated to all CT scans of the abdomen/pelvis performed in the United States, “this would lead to 23,000 radiation-induced cancer cases per year.”

As for why radiologists may order extra scans, coauthor Dr. J. Louis Hinshaw, also with the UW-Madison, said it may be that radiologists simply have the ability and tools available to perform the tests. Also, protocols are set up on CT scanners beforehand and are often designed to answer “what if” scenarios, in which additional views may be needed. “There is some risk-aversion that comes into play,” he said at the briefing.

Of the 500 patients, 7% had findings that would not have been identified without the extra scans, but most of these were not clinically relevant, Dr. Hinshaw said.

The Radiological Society of North America has partnered with the American College of Radiology to create a task force on adult radiation protection to increase awareness of cumulative dose and radiation risks.

Both researchers stressed that CT is a valuable diagnostic tool and that the study findings should not impede use of the technology.

Press briefing moderator Dr. Robert Zimmerman, professor of radiology at Weill Cornell Medical College in New York, concurred. He suggested that patients investigate the radiation protocol at their institution and ask their physicians what steps are being taken to minimize radiation dose.

“We don't want to damage patients, but we know we have the technology that is very useful in saving people's lives,” Dr. Zimmerman said. “We are trying to balance the two.”

In the current study, patients with a malignancy were 22% more likely to receive excess radiation, Dr. Guite said.

Delayed-phase imaging, performed after a contrast agent has accumulated in the kidneys/bladder, accounted for 77% of the unnecessary scans.

There was no study sponsorship, but one coauthor disclosed being a stock holder with NeuWave Medical Inc. and a patent holder with Covidien AG.

'At the doses seen in our study, 1 in 1,000 patients could get a radiation-induced cancer.'

Source DR. GUITE

CHICAGO — The addition of hormone therapy to radiation improves overall survival in men with locally confined prostate cancer, but the benefit appears to be concentrated in intermediate-risk patients, according to initial results from the largest prostate cancer treatment trial to date.

The overall survival rate among the 1,979 men in the Radiation Therapy Oncology Group (RTOG) 9408 trial was 62% with combined therapy and 57% with radiotherapy alone at 8 years, Dr. Christopher U. Jones reported in a late-breaking abstract at the annual meeting of the American Society for Therapeutic Radiology and Oncology.

Intermediate-risk men who received 4 months of androgen suppression plus radiotherapy had the most pronounced benefit, with an overall survival rate of 72% vs. 66% for their radiation-only controls. The overall survival rate was 66% and 58%, respectively, in high-risk men and 76% compared with 73% in low-risk men.

RTOG 9408 is “a landmark, practice-changing study,.” said Dr. Matthew R. Smith, of the department of hematology/oncology, Massachusetts General Hospital, Boston. It provides “the first compelling evidence of a survival benefit for short-term androgen deprivation therapy in this intermediate-risk subgroup” treated with conventional radiation, he said. The number needed to treat was 17.

The results of RTOG 9408 had been eagerly anticipated because androgen-deprivation therapy has been widely adopted in men with localized disease, including those at low risk, despite the lack of a compelling survival benefit and emerging evidence of treatment-related morbidity including decreased bone mineral density, greater risk for clinical fractures, and increased triglycerides and insulin sensitivity, Dr. Smith said.

“RTOG 9408 definitively establishes that there is no benefit for androgen deprivation therapy in patients with low-risk disease,” he said. “Cancer control rates are outstanding with both conventional and high-dose radiation therapy in this low-risk group. Unquestionably this is a setting where less is more.”

The trial does not answer whether androgen deprivation is necessary in patients with intermediate-risk disease treated with more modern high-dose radiation techniques, he added. This question will be addressed in other trials, including the recently opened RTOG 0815 trial.

Patients in the current trial were enrolled from October 1994 to April 2001, and randomized to hormones plus radiotherapy (987 patients) or radiotherapy alone (992). All received 66.6 Gy of radiation, a dose slightly lower than that currently used with newer techniques such as intensity-modulated radiation therapy. Androgen deprivation therapy was administered for 2 months before and 2 months during radiation.

At baseline, patients had T1b-T2b adenocarcinoma of the prostate and a prostate-specific antigen (PSA) level of 20 or less. Median age was 71 years.

The low-risk group included 685 patients with a Gleason score of 6 or less, a PSA of 10 or less and no T2b disease. The 1,068 intermediate-risk patients had a Gleason score of 7 or a Gleason of 6 or less and either a PSA of 10-20 or T2b disease. The 226 high-risk patients had a Gleason score of 8-10.

The addition of short-course hormones to radiation did not increase the risk of death from intercurrent disease, said Dr. Jones, a radiation oncologist in Sacramento, Calif.

The actuarial 10-year death rate from intercurrent disease, excluding deaths from prostate cancer, was 35% in the combination arm and 37% in the radiation-only arm.

Dr. Jones reported no conflicts of interest.

The study was supported by grants from the National Cancer Institute in Bethesda, Md.

CHICAGO — The addition of hormone therapy to radiation improves overall survival in men with locally confined prostate cancer, but the benefit appears to be concentrated in intermediate-risk patients, according to initial results from the largest prostate cancer treatment trial to date.

The overall survival rate among the 1,979 men in the Radiation Therapy Oncology Group (RTOG) 9408 trial was 62% with combined therapy and 57% with radiotherapy alone at 8 years, Dr. Christopher U. Jones reported in a late-breaking abstract at the annual meeting of the American Society for Therapeutic Radiology and Oncology.

Intermediate-risk men who received 4 months of androgen suppression plus radiotherapy had the most pronounced benefit, with an overall survival rate of 72% vs. 66% for their radiation-only controls. The overall survival rate was 66% and 58%, respectively, in high-risk men and 76% compared with 73% in low-risk men.

RTOG 9408 is “a landmark, practice-changing study,.” said Dr. Matthew R. Smith, of the department of hematology/oncology, Massachusetts General Hospital, Boston. It provides “the first compelling evidence of a survival benefit for short-term androgen deprivation therapy in this intermediate-risk subgroup” treated with conventional radiation, he said. The number needed to treat was 17.

The results of RTOG 9408 had been eagerly anticipated because androgen-deprivation therapy has been widely adopted in men with localized disease, including those at low risk, despite the lack of a compelling survival benefit and emerging evidence of treatment-related morbidity including decreased bone mineral density, greater risk for clinical fractures, and increased triglycerides and insulin sensitivity, Dr. Smith said.

“RTOG 9408 definitively establishes that there is no benefit for androgen deprivation therapy in patients with low-risk disease,” he said. “Cancer control rates are outstanding with both conventional and high-dose radiation therapy in this low-risk group. Unquestionably this is a setting where less is more.”

The trial does not answer whether androgen deprivation is necessary in patients with intermediate-risk disease treated with more modern high-dose radiation techniques, he added. This question will be addressed in other trials, including the recently opened RTOG 0815 trial.

Patients in the current trial were enrolled from October 1994 to April 2001, and randomized to hormones plus radiotherapy (987 patients) or radiotherapy alone (992). All received 66.6 Gy of radiation, a dose slightly lower than that currently used with newer techniques such as intensity-modulated radiation therapy. Androgen deprivation therapy was administered for 2 months before and 2 months during radiation.

At baseline, patients had T1b-T2b adenocarcinoma of the prostate and a prostate-specific antigen (PSA) level of 20 or less. Median age was 71 years.

The low-risk group included 685 patients with a Gleason score of 6 or less, a PSA of 10 or less and no T2b disease. The 1,068 intermediate-risk patients had a Gleason score of 7 or a Gleason of 6 or less and either a PSA of 10-20 or T2b disease. The 226 high-risk patients had a Gleason score of 8-10.

The addition of short-course hormones to radiation did not increase the risk of death from intercurrent disease, said Dr. Jones, a radiation oncologist in Sacramento, Calif.

The actuarial 10-year death rate from intercurrent disease, excluding deaths from prostate cancer, was 35% in the combination arm and 37% in the radiation-only arm.

Dr. Jones reported no conflicts of interest.

The study was supported by grants from the National Cancer Institute in Bethesda, Md.

CHICAGO — The addition of hormone therapy to radiation improves overall survival in men with locally confined prostate cancer, but the benefit appears to be concentrated in intermediate-risk patients, according to initial results from the largest prostate cancer treatment trial to date.

The overall survival rate among the 1,979 men in the Radiation Therapy Oncology Group (RTOG) 9408 trial was 62% with combined therapy and 57% with radiotherapy alone at 8 years, Dr. Christopher U. Jones reported in a late-breaking abstract at the annual meeting of the American Society for Therapeutic Radiology and Oncology.

Intermediate-risk men who received 4 months of androgen suppression plus radiotherapy had the most pronounced benefit, with an overall survival rate of 72% vs. 66% for their radiation-only controls. The overall survival rate was 66% and 58%, respectively, in high-risk men and 76% compared with 73% in low-risk men.

RTOG 9408 is “a landmark, practice-changing study,.” said Dr. Matthew R. Smith, of the department of hematology/oncology, Massachusetts General Hospital, Boston. It provides “the first compelling evidence of a survival benefit for short-term androgen deprivation therapy in this intermediate-risk subgroup” treated with conventional radiation, he said. The number needed to treat was 17.

The results of RTOG 9408 had been eagerly anticipated because androgen-deprivation therapy has been widely adopted in men with localized disease, including those at low risk, despite the lack of a compelling survival benefit and emerging evidence of treatment-related morbidity including decreased bone mineral density, greater risk for clinical fractures, and increased triglycerides and insulin sensitivity, Dr. Smith said.

“RTOG 9408 definitively establishes that there is no benefit for androgen deprivation therapy in patients with low-risk disease,” he said. “Cancer control rates are outstanding with both conventional and high-dose radiation therapy in this low-risk group. Unquestionably this is a setting where less is more.”

The trial does not answer whether androgen deprivation is necessary in patients with intermediate-risk disease treated with more modern high-dose radiation techniques, he added. This question will be addressed in other trials, including the recently opened RTOG 0815 trial.

Patients in the current trial were enrolled from October 1994 to April 2001, and randomized to hormones plus radiotherapy (987 patients) or radiotherapy alone (992). All received 66.6 Gy of radiation, a dose slightly lower than that currently used with newer techniques such as intensity-modulated radiation therapy. Androgen deprivation therapy was administered for 2 months before and 2 months during radiation.

At baseline, patients had T1b-T2b adenocarcinoma of the prostate and a prostate-specific antigen (PSA) level of 20 or less. Median age was 71 years.

The low-risk group included 685 patients with a Gleason score of 6 or less, a PSA of 10 or less and no T2b disease. The 1,068 intermediate-risk patients had a Gleason score of 7 or a Gleason of 6 or less and either a PSA of 10-20 or T2b disease. The 226 high-risk patients had a Gleason score of 8-10.

The addition of short-course hormones to radiation did not increase the risk of death from intercurrent disease, said Dr. Jones, a radiation oncologist in Sacramento, Calif.

The actuarial 10-year death rate from intercurrent disease, excluding deaths from prostate cancer, was 35% in the combination arm and 37% in the radiation-only arm.

Dr. Jones reported no conflicts of interest.

The study was supported by grants from the National Cancer Institute in Bethesda, Md.