Heidi Splete

Major Finding: An 8-week yoga program significantly reduced symptoms in women with fibromyalgia.

Data Source: A randomized, controlled trial of 53 women with fibromyalgia.

Disclosures: None reported.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group.

More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study.

As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said.

On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also are planning to study important changes that the yoga program may produce in neurally based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

On average, patients spent 40 minutes practicing yoga at home, including about 13 minutes of seated meditation.

Source ©brandXpictures

Major Finding: An 8-week yoga program significantly reduced symptoms in women with fibromyalgia.

Data Source: A randomized, controlled trial of 53 women with fibromyalgia.

Disclosures: None reported.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group.

More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study.

As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said.

On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also are planning to study important changes that the yoga program may produce in neurally based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

On average, patients spent 40 minutes practicing yoga at home, including about 13 minutes of seated meditation.

Source ©brandXpictures

Major Finding: An 8-week yoga program significantly reduced symptoms in women with fibromyalgia.

Data Source: A randomized, controlled trial of 53 women with fibromyalgia.

Disclosures: None reported.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group.

More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study.

As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said.

On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also are planning to study important changes that the yoga program may produce in neurally based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

On average, patients spent 40 minutes practicing yoga at home, including about 13 minutes of seated meditation.

Source ©brandXpictures

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO – About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

The researchers did not identify specific side effects.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs, the researchers noted.

In addition, after controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were significantly less likely to be satisfied with the side effects compared with those who were taking one AED, the researchers reported.

The study was limited by the use of self-reports, but the results confirm that drug-related side effects remain a significant problem for epilepsy patients and highlight the need to develop more tolerable treatments, the researchers said, adding that “further research is needed to quantify the impact of AED treatment on other patient-reported outcomes, including health status.”

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO – About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

The researchers did not identify specific side effects.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs, the researchers noted.

In addition, after controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were significantly less likely to be satisfied with the side effects compared with those who were taking one AED, the researchers reported.

The study was limited by the use of self-reports, but the results confirm that drug-related side effects remain a significant problem for epilepsy patients and highlight the need to develop more tolerable treatments, the researchers said, adding that “further research is needed to quantify the impact of AED treatment on other patient-reported outcomes, including health status.”

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO – About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

The researchers did not identify specific side effects.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs, the researchers noted.

In addition, after controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were significantly less likely to be satisfied with the side effects compared with those who were taking one AED, the researchers reported.

The study was limited by the use of self-reports, but the results confirm that drug-related side effects remain a significant problem for epilepsy patients and highlight the need to develop more tolerable treatments, the researchers said, adding that “further research is needed to quantify the impact of AED treatment on other patient-reported outcomes, including health status.”

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.

“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” wrote Dr. Nisheet Waghray of MetroHealth Medical Center in Cleveland, and colleagues. They presented their findings in a poster Oct. 18 at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.

The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.

All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.

The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.

The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.

The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.

The researchers said that they had no financial conflicts to disclose.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck and AstraZeneca.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (RR, 2.35), stroke (RR, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said.

Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” Mr. Mottillo and his colleagues said.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck and AstraZeneca.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (RR, 2.35), stroke (RR, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said.

Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” Mr. Mottillo and his colleagues said.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck and AstraZeneca.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (RR, 2.35), stroke (RR, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said.

Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” Mr. Mottillo and his colleagues said.

One in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. The improvement stems from earlier disease detection and a multimodal approach to treatment at different stages, said Dr. Aman Buzdar, the study's lead author.

The study's goal was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients at the MD Anderson Cancer Center in Houston. The survival rates seen at MD Anderson are generalizable to the rates at smaller regional hospitals and community cancer centers, Dr. Buzdar said.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. If the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said at the press briefing.

Dr. Buzdar and colleagues reviewed the center's database of approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Dr. Buzdar said he had no conflicts.

One in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. The improvement stems from earlier disease detection and a multimodal approach to treatment at different stages, said Dr. Aman Buzdar, the study's lead author.

The study's goal was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients at the MD Anderson Cancer Center in Houston. The survival rates seen at MD Anderson are generalizable to the rates at smaller regional hospitals and community cancer centers, Dr. Buzdar said.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. If the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said at the press briefing.

Dr. Buzdar and colleagues reviewed the center's database of approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Dr. Buzdar said he had no conflicts.

One in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. The improvement stems from earlier disease detection and a multimodal approach to treatment at different stages, said Dr. Aman Buzdar, the study's lead author.

The study's goal was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients at the MD Anderson Cancer Center in Houston. The survival rates seen at MD Anderson are generalizable to the rates at smaller regional hospitals and community cancer centers, Dr. Buzdar said.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. If the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said at the press briefing.

Dr. Buzdar and colleagues reviewed the center's database of approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Dr. Buzdar said he had no conflicts.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some randomized trials,” Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues reported.

Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The death rate in the screened group of women aged 50-69 years was 18 per 100,000 person-years, vs. 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone. Part of the reductioniwas “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

However, “the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The Cancer Registry of Norway and the Research Council of Norway funded the study. Dr. Kalager and associates had no financial conflicts to disclose.

View on the News

The Impact of Screening Mammography has Declined

Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%–23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42).

Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.”

He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.

He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment.

Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality.

“Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.

Dr. Welch also raised the issue of the false alarm.

“Up to 1,000 women will have at least one 'false alarm,' about half of whom will undergo biopsy.”

He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.”

Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”

H. GILBERT WELCH, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some randomized trials,” Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues reported.

Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The death rate in the screened group of women aged 50-69 years was 18 per 100,000 person-years, vs. 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone. Part of the reductioniwas “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

However, “the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The Cancer Registry of Norway and the Research Council of Norway funded the study. Dr. Kalager and associates had no financial conflicts to disclose.

View on the News

The Impact of Screening Mammography has Declined

Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%–23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42).

Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.”

He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.

He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment.

Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality.

“Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.

Dr. Welch also raised the issue of the false alarm.

“Up to 1,000 women will have at least one 'false alarm,' about half of whom will undergo biopsy.”

He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.”

Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”

H. GILBERT WELCH, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some randomized trials,” Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues reported.

Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The death rate in the screened group of women aged 50-69 years was 18 per 100,000 person-years, vs. 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone. Part of the reductioniwas “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

However, “the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The Cancer Registry of Norway and the Research Council of Norway funded the study. Dr. Kalager and associates had no financial conflicts to disclose.

View on the News

The Impact of Screening Mammography has Declined

Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%–23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42).

Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.”

He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.

He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment.

Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality.

“Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.

Dr. Welch also raised the issue of the false alarm.

“Up to 1,000 women will have at least one 'false alarm,' about half of whom will undergo biopsy.”

He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.”

Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”

H. GILBERT WELCH, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women. The results were published online on Oct. 14 in the journal Pain.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator and lead study author James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also planning to study important changes that the yoga program may produce in neurally-based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

The researchers had no financial conflicts to disclose.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women. The results were published online on Oct. 14 in the journal Pain.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator and lead study author James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also planning to study important changes that the yoga program may produce in neurally-based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

The researchers had no financial conflicts to disclose.

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women. The results were published online on Oct. 14 in the journal Pain.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator and lead study author James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University in Portland said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530-9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

“We also planning to study important changes that the yoga program may produce in neurally-based abnormal pain processes that are key to the pathophysiology of fibromyalgia,” he said.

The researchers had no financial conflicts to disclose.

NATIONAL HARBOR, Md. – Anastrozole remained superior to tamoxifen as an adjuvant treatment for invasive breast cancer in postmenopausal women, based on 10-year follow-up data from the Arimidex, Tamoxifen Alone or in Combination trial known as ATAC.

After 10 years, the recurrence rate in hormone receptor–positive patients randomized to 5 years of adjuvant anastrozole (Arimidex) was 19.7%, compared with 24% in those who received tamoxifen for the same period. The hazard ratio was 0.79 (P = .0002).

Previous reports from 33, 68, and 100 months into the trial showed that the aromatase inhibitor was significantly more effective at reducing recurrence than tamoxifen, said Dr. Aman Buzdar, a professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston. This analysis assessed outcomes in an intent-to-treat population of 3,125 women who received anastrozole and 3,116 women who received tamoxifen after a median follow-up of 10 years.

The effectiveness of anastrozole, compared with tamoxifen increased over time, Dr. Buzdar noted. The difference in time to relapse between anastrozole and tamoxifen increased from 2.7% at 5 years to 4.3% at 10 years. Deaths following recurrence were lower in the anastrozole patients, although the difference was not statistically significant.

During years 5-9, the risk reduction due to the carryover effects of treatment was 50% in the anastrozole group, compared with 33% in the tamoxifen group (hazard ratio 0.81, P = .03).

The rate of distant recurrence favored anastrozole over tamoxifen at 5 years (7.9% vs. 9.2%, respectively) and 10 years (15.1% vs. 17.7%, respectively) with a P value of .02. Likewise, women treated with anastrazole were less likely to develop contralateral breast cancer; the rates were 1%, compared with 1.8% in the tamoxifen group at year 5, and 3.2% vs. 4.9% at year 10 (HR 0.62, P = .003).

During the treatment period, women taking anastrozole had significantly more fractures, compared with those taking tamoxifen (375 vs. 234, respectively), but no differences in fracture rates appeared between the two groups during the posttreatment period (175 vs. 188, respectively). No significant differences in side effects were observed between the two groups after treatment was completed.

The occurrences of heart attack and stroke were similar between the two groups both during and after treatment. Endometrial cancer was more common in the tamoxifen group, compared with the anastrozole group both on and off treatment. The death rate was 24% in both groups, suggesting no additional morbidity and mortality concerns, Dr. Buzdar said.

“At 10 years of median follow-up, anastrozole is significantly superior to tamoxifen in preventing breast cancer recurrence,” said Dr. Buzdar.

The average age of the women at the 10-year follow-up analysis was 72 years. The total follow-up equaled 48,473 women-years.

AstraZeneca, which manufactures both drugs, supported the study. Dr. Buzdar had no personal financial conflicts to disclose, but one or more of the study’s co-investigators disclosed consulting and funding relationships with AstraZeneca.

NATIONAL HARBOR, Md. – Anastrozole remained superior to tamoxifen as an adjuvant treatment for invasive breast cancer in postmenopausal women, based on 10-year follow-up data from the Arimidex, Tamoxifen Alone or in Combination trial known as ATAC.

After 10 years, the recurrence rate in hormone receptor–positive patients randomized to 5 years of adjuvant anastrozole (Arimidex) was 19.7%, compared with 24% in those who received tamoxifen for the same period. The hazard ratio was 0.79 (P = .0002).

Previous reports from 33, 68, and 100 months into the trial showed that the aromatase inhibitor was significantly more effective at reducing recurrence than tamoxifen, said Dr. Aman Buzdar, a professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston. This analysis assessed outcomes in an intent-to-treat population of 3,125 women who received anastrozole and 3,116 women who received tamoxifen after a median follow-up of 10 years.

The effectiveness of anastrozole, compared with tamoxifen increased over time, Dr. Buzdar noted. The difference in time to relapse between anastrozole and tamoxifen increased from 2.7% at 5 years to 4.3% at 10 years. Deaths following recurrence were lower in the anastrozole patients, although the difference was not statistically significant.

During years 5-9, the risk reduction due to the carryover effects of treatment was 50% in the anastrozole group, compared with 33% in the tamoxifen group (hazard ratio 0.81, P = .03).

The rate of distant recurrence favored anastrozole over tamoxifen at 5 years (7.9% vs. 9.2%, respectively) and 10 years (15.1% vs. 17.7%, respectively) with a P value of .02. Likewise, women treated with anastrazole were less likely to develop contralateral breast cancer; the rates were 1%, compared with 1.8% in the tamoxifen group at year 5, and 3.2% vs. 4.9% at year 10 (HR 0.62, P = .003).

During the treatment period, women taking anastrozole had significantly more fractures, compared with those taking tamoxifen (375 vs. 234, respectively), but no differences in fracture rates appeared between the two groups during the posttreatment period (175 vs. 188, respectively). No significant differences in side effects were observed between the two groups after treatment was completed.

The occurrences of heart attack and stroke were similar between the two groups both during and after treatment. Endometrial cancer was more common in the tamoxifen group, compared with the anastrozole group both on and off treatment. The death rate was 24% in both groups, suggesting no additional morbidity and mortality concerns, Dr. Buzdar said.

“At 10 years of median follow-up, anastrozole is significantly superior to tamoxifen in preventing breast cancer recurrence,” said Dr. Buzdar.

The average age of the women at the 10-year follow-up analysis was 72 years. The total follow-up equaled 48,473 women-years.

AstraZeneca, which manufactures both drugs, supported the study. Dr. Buzdar had no personal financial conflicts to disclose, but one or more of the study’s co-investigators disclosed consulting and funding relationships with AstraZeneca.

NATIONAL HARBOR, Md. – Anastrozole remained superior to tamoxifen as an adjuvant treatment for invasive breast cancer in postmenopausal women, based on 10-year follow-up data from the Arimidex, Tamoxifen Alone or in Combination trial known as ATAC.

After 10 years, the recurrence rate in hormone receptor–positive patients randomized to 5 years of adjuvant anastrozole (Arimidex) was 19.7%, compared with 24% in those who received tamoxifen for the same period. The hazard ratio was 0.79 (P = .0002).

Previous reports from 33, 68, and 100 months into the trial showed that the aromatase inhibitor was significantly more effective at reducing recurrence than tamoxifen, said Dr. Aman Buzdar, a professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston. This analysis assessed outcomes in an intent-to-treat population of 3,125 women who received anastrozole and 3,116 women who received tamoxifen after a median follow-up of 10 years.

The effectiveness of anastrozole, compared with tamoxifen increased over time, Dr. Buzdar noted. The difference in time to relapse between anastrozole and tamoxifen increased from 2.7% at 5 years to 4.3% at 10 years. Deaths following recurrence were lower in the anastrozole patients, although the difference was not statistically significant.

During years 5-9, the risk reduction due to the carryover effects of treatment was 50% in the anastrozole group, compared with 33% in the tamoxifen group (hazard ratio 0.81, P = .03).

The rate of distant recurrence favored anastrozole over tamoxifen at 5 years (7.9% vs. 9.2%, respectively) and 10 years (15.1% vs. 17.7%, respectively) with a P value of .02. Likewise, women treated with anastrazole were less likely to develop contralateral breast cancer; the rates were 1%, compared with 1.8% in the tamoxifen group at year 5, and 3.2% vs. 4.9% at year 10 (HR 0.62, P = .003).

During the treatment period, women taking anastrozole had significantly more fractures, compared with those taking tamoxifen (375 vs. 234, respectively), but no differences in fracture rates appeared between the two groups during the posttreatment period (175 vs. 188, respectively). No significant differences in side effects were observed between the two groups after treatment was completed.

The occurrences of heart attack and stroke were similar between the two groups both during and after treatment. Endometrial cancer was more common in the tamoxifen group, compared with the anastrozole group both on and off treatment. The death rate was 24% in both groups, suggesting no additional morbidity and mortality concerns, Dr. Buzdar said.

“At 10 years of median follow-up, anastrozole is significantly superior to tamoxifen in preventing breast cancer recurrence,” said Dr. Buzdar.

The average age of the women at the 10-year follow-up analysis was 72 years. The total follow-up equaled 48,473 women-years.

AstraZeneca, which manufactures both drugs, supported the study. Dr. Buzdar had no personal financial conflicts to disclose, but one or more of the study’s co-investigators disclosed consulting and funding relationships with AstraZeneca.

NATIONAL HARBOR, Md. – Breast irradiation with 3-D conformal external beam therapy produced no significant toxicity in early results from more than 1,000 breast cancer patients with 3 years’ follow-up in a phase III trial.

Recent small studies have shown significant short-term toxicity related to the use of 3-D conformal external beam therapy (CEBT), with a 10%-20% incidence of unacceptable fibrosis or poor cosmesis, said Dr. Thomas Julian of the West Penn Allegheny Cancer Institute based in Pittsburgh.

The primary objective of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39/Radiation Therapy Oncology Group (RTOG) 0413 study is to compare partial-breast irradiation vs. whole-breast irradiation for local tumor control after lumpectomy in patients with early-stage breast cancer. The study includes 3-D CEBT.

In light of the toxicity findings from other studies, Dr. Julian and colleagues reviewed toxicity data from 1,339 women in the NSABP B-39/RTOG 0413 study who were randomized to 3-D CEBT for partial-breast irradiation and who had been followed for an average of 37 months, including 1,004 women with at least 36 months of follow-up. Approximately two-thirds of the women were postmenopausal. A total of 68% had noninvasive breast cancer, 24% had ductal carcinoma in situ, and 8% had invasive stage I breast cancer.

No grade 4 or 5 toxicities were reported, and grade 3 side effects were rare in results presented at the Breast Cancer Symposium, which was sponsored by the American Society of Clinical Oncology.

Virtually all patients (97%) were free of chemoradiation dermatitis. Just 2% had grade 1 of this toxicity, 1% had grade 2, and fewer than 1% had grade 3.

The highest toxicity rates were related to radiation dermatitis. In all, 36% of patients had no toxicity, 52% had grade 1 toxicity, 11% had grade 2, and 1% had grade 3.

No hyperpigmentation occurred in 52% of patients; 42% had grade 1 toxicity, and 6% had grade 2. Induration also was uncommon, with 67% of patients having none, whereas 25% had grade 1, 7% had grade 2, and 1% had grade 3. And telangiectasia was rare, with 89% having none, 9% having grade 1, 2% having grade 2, and fewer than 1% having grade 3.

Similarly, 71% of the patients had no fibrosis-cosmesis toxicity; 16% had grade 1, 10% had grade 2, and 3% grade 3. Deep connective tissue fibrosis was not a problem for 72% of the patients; another 16% had grade 1, 11% grade 2, and 1% had grade 3.

“Contrary to findings in recent published reports, the 3-D conformal APBI [accelerated partial breast irradiation] toxicity rates in our trial are acceptably low,” said Dr. Julian.

“Our trial surpasses others reported in patient number and length of follow-up, emphasizing the important of large, phase III, randomized trials with vigorous quality assurance to determine treatment outcomes and avoid the bias that can arise from small, single-institution series,” he said.

The whole-breast irradiation group protocol was 50 Gy (2.0 Gy per fraction) or 50.4 Gy (1.8 Gy per fraction) to the whole breast, followed by an optional boost to 60.0 -66.6 Gy. The partial-breast irradiation protocol involved one of three options: 34 Gy in 3.4-Gy fractions using multicatheter brachytherapy, 34 Gy in 3.4-Gy fractions using a MammoSite balloon catheter, or 38.5 Gy in 3.85-Gy fractions using 3-D conformal external beam radiation.

The study was supported in part by Nucletron.

NATIONAL HARBOR, Md. – Breast irradiation with 3-D conformal external beam therapy produced no significant toxicity in early results from more than 1,000 breast cancer patients with 3 years’ follow-up in a phase III trial.

Recent small studies have shown significant short-term toxicity related to the use of 3-D conformal external beam therapy (CEBT), with a 10%-20% incidence of unacceptable fibrosis or poor cosmesis, said Dr. Thomas Julian of the West Penn Allegheny Cancer Institute based in Pittsburgh.

The primary objective of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39/Radiation Therapy Oncology Group (RTOG) 0413 study is to compare partial-breast irradiation vs. whole-breast irradiation for local tumor control after lumpectomy in patients with early-stage breast cancer. The study includes 3-D CEBT.

In light of the toxicity findings from other studies, Dr. Julian and colleagues reviewed toxicity data from 1,339 women in the NSABP B-39/RTOG 0413 study who were randomized to 3-D CEBT for partial-breast irradiation and who had been followed for an average of 37 months, including 1,004 women with at least 36 months of follow-up. Approximately two-thirds of the women were postmenopausal. A total of 68% had noninvasive breast cancer, 24% had ductal carcinoma in situ, and 8% had invasive stage I breast cancer.

No grade 4 or 5 toxicities were reported, and grade 3 side effects were rare in results presented at the Breast Cancer Symposium, which was sponsored by the American Society of Clinical Oncology.

Virtually all patients (97%) were free of chemoradiation dermatitis. Just 2% had grade 1 of this toxicity, 1% had grade 2, and fewer than 1% had grade 3.

The highest toxicity rates were related to radiation dermatitis. In all, 36% of patients had no toxicity, 52% had grade 1 toxicity, 11% had grade 2, and 1% had grade 3.

No hyperpigmentation occurred in 52% of patients; 42% had grade 1 toxicity, and 6% had grade 2. Induration also was uncommon, with 67% of patients having none, whereas 25% had grade 1, 7% had grade 2, and 1% had grade 3. And telangiectasia was rare, with 89% having none, 9% having grade 1, 2% having grade 2, and fewer than 1% having grade 3.

Similarly, 71% of the patients had no fibrosis-cosmesis toxicity; 16% had grade 1, 10% had grade 2, and 3% grade 3. Deep connective tissue fibrosis was not a problem for 72% of the patients; another 16% had grade 1, 11% grade 2, and 1% had grade 3.

“Contrary to findings in recent published reports, the 3-D conformal APBI [accelerated partial breast irradiation] toxicity rates in our trial are acceptably low,” said Dr. Julian.

“Our trial surpasses others reported in patient number and length of follow-up, emphasizing the important of large, phase III, randomized trials with vigorous quality assurance to determine treatment outcomes and avoid the bias that can arise from small, single-institution series,” he said.

The whole-breast irradiation group protocol was 50 Gy (2.0 Gy per fraction) or 50.4 Gy (1.8 Gy per fraction) to the whole breast, followed by an optional boost to 60.0 -66.6 Gy. The partial-breast irradiation protocol involved one of three options: 34 Gy in 3.4-Gy fractions using multicatheter brachytherapy, 34 Gy in 3.4-Gy fractions using a MammoSite balloon catheter, or 38.5 Gy in 3.85-Gy fractions using 3-D conformal external beam radiation.

The study was supported in part by Nucletron.

NATIONAL HARBOR, Md. – Breast irradiation with 3-D conformal external beam therapy produced no significant toxicity in early results from more than 1,000 breast cancer patients with 3 years’ follow-up in a phase III trial.

Recent small studies have shown significant short-term toxicity related to the use of 3-D conformal external beam therapy (CEBT), with a 10%-20% incidence of unacceptable fibrosis or poor cosmesis, said Dr. Thomas Julian of the West Penn Allegheny Cancer Institute based in Pittsburgh.

The primary objective of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39/Radiation Therapy Oncology Group (RTOG) 0413 study is to compare partial-breast irradiation vs. whole-breast irradiation for local tumor control after lumpectomy in patients with early-stage breast cancer. The study includes 3-D CEBT.

In light of the toxicity findings from other studies, Dr. Julian and colleagues reviewed toxicity data from 1,339 women in the NSABP B-39/RTOG 0413 study who were randomized to 3-D CEBT for partial-breast irradiation and who had been followed for an average of 37 months, including 1,004 women with at least 36 months of follow-up. Approximately two-thirds of the women were postmenopausal. A total of 68% had noninvasive breast cancer, 24% had ductal carcinoma in situ, and 8% had invasive stage I breast cancer.

No grade 4 or 5 toxicities were reported, and grade 3 side effects were rare in results presented at the Breast Cancer Symposium, which was sponsored by the American Society of Clinical Oncology.

Virtually all patients (97%) were free of chemoradiation dermatitis. Just 2% had grade 1 of this toxicity, 1% had grade 2, and fewer than 1% had grade 3.

The highest toxicity rates were related to radiation dermatitis. In all, 36% of patients had no toxicity, 52% had grade 1 toxicity, 11% had grade 2, and 1% had grade 3.

No hyperpigmentation occurred in 52% of patients; 42% had grade 1 toxicity, and 6% had grade 2. Induration also was uncommon, with 67% of patients having none, whereas 25% had grade 1, 7% had grade 2, and 1% had grade 3. And telangiectasia was rare, with 89% having none, 9% having grade 1, 2% having grade 2, and fewer than 1% having grade 3.

Similarly, 71% of the patients had no fibrosis-cosmesis toxicity; 16% had grade 1, 10% had grade 2, and 3% grade 3. Deep connective tissue fibrosis was not a problem for 72% of the patients; another 16% had grade 1, 11% grade 2, and 1% had grade 3.

“Contrary to findings in recent published reports, the 3-D conformal APBI [accelerated partial breast irradiation] toxicity rates in our trial are acceptably low,” said Dr. Julian.

“Our trial surpasses others reported in patient number and length of follow-up, emphasizing the important of large, phase III, randomized trials with vigorous quality assurance to determine treatment outcomes and avoid the bias that can arise from small, single-institution series,” he said.

The whole-breast irradiation group protocol was 50 Gy (2.0 Gy per fraction) or 50.4 Gy (1.8 Gy per fraction) to the whole breast, followed by an optional boost to 60.0 -66.6 Gy. The partial-breast irradiation protocol involved one of three options: 34 Gy in 3.4-Gy fractions using multicatheter brachytherapy, 34 Gy in 3.4-Gy fractions using a MammoSite balloon catheter, or 38.5 Gy in 3.85-Gy fractions using 3-D conformal external beam radiation.

The study was supported in part by Nucletron.