Breast Cancer

SAN ANTONIO – Diagnosis of diabetes within the prior 4 years was independently associated with breast cancer in a Swedish case-control study.

Dr. Håkan Olsson reported at the San Antonio Breast Cancer Symposium on all 2,724 women diagnosed with breast cancer in southern Sweden during 2005-2007 and 20,542 matched controls. He and his coworkers were interested in how the malignancy is related to diabetes, obesity, and serum lipid levels.

In a multivariate analysis adjusted for obesity, serum lipids, and other potential confounders, the breast cancer patients were 37% more likely than controls to have been diagnosed with diabetes during the previous 4 years. Yet diabetes diagnosed 4-10 years previously was not associated with a significant increase in breast cancer, said Dr. Olsson, professor of oncology and cancer epidemiology at Lund (Sweden) University.

The most likely explanation for the finding that only relatively recently diagnosed diabetes was linked to increased risk of breast cancer is that the diabetic hormonal milieu doesn’t initiate breast tumors, but rather it promotes the growth of tumors that are already established but dormant. This would be analogous to the relationship between hormone replacement therapy and breast cancer, where the Early Breast Cancer Trialists’ Collaborative Group has demonstrated that it’s only present use, not past use, that increases the risk of malignancy, he observed.

Dr. Olsson and coworkers also looked at the relationship between diabetes and all other types of cancer among patients in the comprehensive regional cancer registry. They found that three other types of cancer in addition to breast cancer were associated with a significantly increased likelihood of prior diagnosis of diabetes compared to controls: pancreatic cancer, with a 2.36-fold increased rate; liver cancer, with a 3.43-fold increased odds; and colon cancer, with a 1.49-fold increase.

Dr. Olsson and coworkers also looked at the relationship between the antidiabetic medications metformin and glargine and cancer risk among all patients in the cancer registry, not just those with breast cancer. Use of the long-acting insulin analog glargine, which is quite common among Swedish type 2 diabetic patients, was associated with a 2.88-fold increased overall cancer risk. In contrast, metformin use was associated with an 8% reduction in overall cancer risk, although this association didn’t achieve statistical significance, unlike the relationship between glargine and overall cancer.

An association between glargine and increased cancer risk has also been noted in several other studies, according to Dr. Olsson.

In the southern Swedish breast cancer cohort, obesity after age 60 was independently associated with a 55% increased likelihood of breast cancer after controlling for diabetes and other factors in a multivariate analysis. However, obesity in women under age 60 was associated with a nonsignificant 41% reduction in breast cancer.

To Dr. Olsson’s surprise, the investigators found that hypercholesterolemia was independently associated with a 27% reduction in the prevalence of breast cancer. In other words, significantly fewer breast cancer patients had a high cholesterol level compared with the general population. This is a novel finding that requires confirmation in other data sets, he added.

The relationship between metformin and breast cancer is under study in the large, prospective, phase III, double-blind, randomized MA 32 clinical trial led by the National Cancer Institute of Canada Clinical Trials Group. More than 1,000 nondiabetic patients with early-stage breast cancer have been randomized to metformin or placebo. Key end points in the MA 32 study include overall and disease-free survival. Results are about 5 years off.

Dr. Olsson’s study was funded by the Southern Sweden Health Care Region. He declared having no relevant financial relationships.

SAN ANTONIO – Diagnosis of diabetes within the prior 4 years was independently associated with breast cancer in a Swedish case-control study.

Dr. Håkan Olsson reported at the San Antonio Breast Cancer Symposium on all 2,724 women diagnosed with breast cancer in southern Sweden during 2005-2007 and 20,542 matched controls. He and his coworkers were interested in how the malignancy is related to diabetes, obesity, and serum lipid levels.

In a multivariate analysis adjusted for obesity, serum lipids, and other potential confounders, the breast cancer patients were 37% more likely than controls to have been diagnosed with diabetes during the previous 4 years. Yet diabetes diagnosed 4-10 years previously was not associated with a significant increase in breast cancer, said Dr. Olsson, professor of oncology and cancer epidemiology at Lund (Sweden) University.

The most likely explanation for the finding that only relatively recently diagnosed diabetes was linked to increased risk of breast cancer is that the diabetic hormonal milieu doesn’t initiate breast tumors, but rather it promotes the growth of tumors that are already established but dormant. This would be analogous to the relationship between hormone replacement therapy and breast cancer, where the Early Breast Cancer Trialists’ Collaborative Group has demonstrated that it’s only present use, not past use, that increases the risk of malignancy, he observed.

Dr. Olsson and coworkers also looked at the relationship between diabetes and all other types of cancer among patients in the comprehensive regional cancer registry. They found that three other types of cancer in addition to breast cancer were associated with a significantly increased likelihood of prior diagnosis of diabetes compared to controls: pancreatic cancer, with a 2.36-fold increased rate; liver cancer, with a 3.43-fold increased odds; and colon cancer, with a 1.49-fold increase.

Dr. Olsson and coworkers also looked at the relationship between the antidiabetic medications metformin and glargine and cancer risk among all patients in the cancer registry, not just those with breast cancer. Use of the long-acting insulin analog glargine, which is quite common among Swedish type 2 diabetic patients, was associated with a 2.88-fold increased overall cancer risk. In contrast, metformin use was associated with an 8% reduction in overall cancer risk, although this association didn’t achieve statistical significance, unlike the relationship between glargine and overall cancer.

An association between glargine and increased cancer risk has also been noted in several other studies, according to Dr. Olsson.

In the southern Swedish breast cancer cohort, obesity after age 60 was independently associated with a 55% increased likelihood of breast cancer after controlling for diabetes and other factors in a multivariate analysis. However, obesity in women under age 60 was associated with a nonsignificant 41% reduction in breast cancer.

To Dr. Olsson’s surprise, the investigators found that hypercholesterolemia was independently associated with a 27% reduction in the prevalence of breast cancer. In other words, significantly fewer breast cancer patients had a high cholesterol level compared with the general population. This is a novel finding that requires confirmation in other data sets, he added.

The relationship between metformin and breast cancer is under study in the large, prospective, phase III, double-blind, randomized MA 32 clinical trial led by the National Cancer Institute of Canada Clinical Trials Group. More than 1,000 nondiabetic patients with early-stage breast cancer have been randomized to metformin or placebo. Key end points in the MA 32 study include overall and disease-free survival. Results are about 5 years off.

Dr. Olsson’s study was funded by the Southern Sweden Health Care Region. He declared having no relevant financial relationships.

SAN ANTONIO – Diagnosis of diabetes within the prior 4 years was independently associated with breast cancer in a Swedish case-control study.

Dr. Håkan Olsson reported at the San Antonio Breast Cancer Symposium on all 2,724 women diagnosed with breast cancer in southern Sweden during 2005-2007 and 20,542 matched controls. He and his coworkers were interested in how the malignancy is related to diabetes, obesity, and serum lipid levels.

In a multivariate analysis adjusted for obesity, serum lipids, and other potential confounders, the breast cancer patients were 37% more likely than controls to have been diagnosed with diabetes during the previous 4 years. Yet diabetes diagnosed 4-10 years previously was not associated with a significant increase in breast cancer, said Dr. Olsson, professor of oncology and cancer epidemiology at Lund (Sweden) University.

The most likely explanation for the finding that only relatively recently diagnosed diabetes was linked to increased risk of breast cancer is that the diabetic hormonal milieu doesn’t initiate breast tumors, but rather it promotes the growth of tumors that are already established but dormant. This would be analogous to the relationship between hormone replacement therapy and breast cancer, where the Early Breast Cancer Trialists’ Collaborative Group has demonstrated that it’s only present use, not past use, that increases the risk of malignancy, he observed.

Dr. Olsson and coworkers also looked at the relationship between diabetes and all other types of cancer among patients in the comprehensive regional cancer registry. They found that three other types of cancer in addition to breast cancer were associated with a significantly increased likelihood of prior diagnosis of diabetes compared to controls: pancreatic cancer, with a 2.36-fold increased rate; liver cancer, with a 3.43-fold increased odds; and colon cancer, with a 1.49-fold increase.

Dr. Olsson and coworkers also looked at the relationship between the antidiabetic medications metformin and glargine and cancer risk among all patients in the cancer registry, not just those with breast cancer. Use of the long-acting insulin analog glargine, which is quite common among Swedish type 2 diabetic patients, was associated with a 2.88-fold increased overall cancer risk. In contrast, metformin use was associated with an 8% reduction in overall cancer risk, although this association didn’t achieve statistical significance, unlike the relationship between glargine and overall cancer.

An association between glargine and increased cancer risk has also been noted in several other studies, according to Dr. Olsson.

In the southern Swedish breast cancer cohort, obesity after age 60 was independently associated with a 55% increased likelihood of breast cancer after controlling for diabetes and other factors in a multivariate analysis. However, obesity in women under age 60 was associated with a nonsignificant 41% reduction in breast cancer.

To Dr. Olsson’s surprise, the investigators found that hypercholesterolemia was independently associated with a 27% reduction in the prevalence of breast cancer. In other words, significantly fewer breast cancer patients had a high cholesterol level compared with the general population. This is a novel finding that requires confirmation in other data sets, he added.

The relationship between metformin and breast cancer is under study in the large, prospective, phase III, double-blind, randomized MA 32 clinical trial led by the National Cancer Institute of Canada Clinical Trials Group. More than 1,000 nondiabetic patients with early-stage breast cancer have been randomized to metformin or placebo. Key end points in the MA 32 study include overall and disease-free survival. Results are about 5 years off.

Dr. Olsson’s study was funded by the Southern Sweden Health Care Region. He declared having no relevant financial relationships.

SAN ANTONIO – Pregnancy-associated breast cancer carries a relatively poor prognosis regardless of whether the malignancy is diagnosed during pregnancy or post partum, a meta-analysis has shown.

The meta-analysis included 29 matched case-control studies totaling 3,529 women with pregnancy-associated breast cancer – defined as breast cancer diagnosed during pregnancy or within 1 year afterward – and 36,914 controls whose breast cancer was unrelated to pregnancy.

This is believed to be the largest-ever meta-analysis addressing the prognosis of pregnancy-associated breast cancer, a relatively rare disease, Dr. Hatem A. Azim Jr. reported at the annual San Antonio Breast Cancer Symposium. In addition to the published reports, Dr. Azim and coauthors contacted the various study investigators to obtain unpublished data.

Women with pregnancy-associated breast cancer had a significantly greater risk of death than did controls, Dr. Azim and colleagues found: In a multivariate analysis, pregnancy increased the overall mortality rate by 46%. This held true even after adjustment for differences in tumor size, nodal status, and systemic therapy, according to Dr. Azim of the Jules Bordet Institute at the Free University of Brussels.

The secondary outcome measure in the meta-analysis was disease-free survival. Patients with pregnancy-associated breast cancer had a 59% increased risk of relapse compared with women with nonpregnancy-related breast cancer.

Roughly 6% of breast cancers are diagnosed in women before the age of 40, and of those only about 10% are diagnosed during pregnancy or within a year after. The relative rarity of this condition precludes conducting definitive large prospective clinical trials addressing patient prognosis.

Despite the rarity of pregnancy-associated breast cancer, however, it’s an important condition for a couple of reasons: The incidence of pregnancy-associated breast cancer is increasing because of the popular trend for delay of childbirth until later in life, and the condition poses a thorny therapeutic challenge because of the poor prognosis.

Dr. Azim reported no relevant financial disclosures.

SAN ANTONIO – Pregnancy-associated breast cancer carries a relatively poor prognosis regardless of whether the malignancy is diagnosed during pregnancy or post partum, a meta-analysis has shown.

The meta-analysis included 29 matched case-control studies totaling 3,529 women with pregnancy-associated breast cancer – defined as breast cancer diagnosed during pregnancy or within 1 year afterward – and 36,914 controls whose breast cancer was unrelated to pregnancy.

This is believed to be the largest-ever meta-analysis addressing the prognosis of pregnancy-associated breast cancer, a relatively rare disease, Dr. Hatem A. Azim Jr. reported at the annual San Antonio Breast Cancer Symposium. In addition to the published reports, Dr. Azim and coauthors contacted the various study investigators to obtain unpublished data.

Women with pregnancy-associated breast cancer had a significantly greater risk of death than did controls, Dr. Azim and colleagues found: In a multivariate analysis, pregnancy increased the overall mortality rate by 46%. This held true even after adjustment for differences in tumor size, nodal status, and systemic therapy, according to Dr. Azim of the Jules Bordet Institute at the Free University of Brussels.

The secondary outcome measure in the meta-analysis was disease-free survival. Patients with pregnancy-associated breast cancer had a 59% increased risk of relapse compared with women with nonpregnancy-related breast cancer.

Roughly 6% of breast cancers are diagnosed in women before the age of 40, and of those only about 10% are diagnosed during pregnancy or within a year after. The relative rarity of this condition precludes conducting definitive large prospective clinical trials addressing patient prognosis.

Despite the rarity of pregnancy-associated breast cancer, however, it’s an important condition for a couple of reasons: The incidence of pregnancy-associated breast cancer is increasing because of the popular trend for delay of childbirth until later in life, and the condition poses a thorny therapeutic challenge because of the poor prognosis.

Dr. Azim reported no relevant financial disclosures.

SAN ANTONIO – Pregnancy-associated breast cancer carries a relatively poor prognosis regardless of whether the malignancy is diagnosed during pregnancy or post partum, a meta-analysis has shown.

The meta-analysis included 29 matched case-control studies totaling 3,529 women with pregnancy-associated breast cancer – defined as breast cancer diagnosed during pregnancy or within 1 year afterward – and 36,914 controls whose breast cancer was unrelated to pregnancy.

This is believed to be the largest-ever meta-analysis addressing the prognosis of pregnancy-associated breast cancer, a relatively rare disease, Dr. Hatem A. Azim Jr. reported at the annual San Antonio Breast Cancer Symposium. In addition to the published reports, Dr. Azim and coauthors contacted the various study investigators to obtain unpublished data.

Women with pregnancy-associated breast cancer had a significantly greater risk of death than did controls, Dr. Azim and colleagues found: In a multivariate analysis, pregnancy increased the overall mortality rate by 46%. This held true even after adjustment for differences in tumor size, nodal status, and systemic therapy, according to Dr. Azim of the Jules Bordet Institute at the Free University of Brussels.

The secondary outcome measure in the meta-analysis was disease-free survival. Patients with pregnancy-associated breast cancer had a 59% increased risk of relapse compared with women with nonpregnancy-related breast cancer.

Roughly 6% of breast cancers are diagnosed in women before the age of 40, and of those only about 10% are diagnosed during pregnancy or within a year after. The relative rarity of this condition precludes conducting definitive large prospective clinical trials addressing patient prognosis.

Despite the rarity of pregnancy-associated breast cancer, however, it’s an important condition for a couple of reasons: The incidence of pregnancy-associated breast cancer is increasing because of the popular trend for delay of childbirth until later in life, and the condition poses a thorny therapeutic challenge because of the poor prognosis.

Dr. Azim reported no relevant financial disclosures.

SAN ANTONIO – Breast cancer patients have an increased prevalence of autoimmune thyroid disease, according to a comprehensive meta-analysis incorporating 26 published studies.

That being said, the cause of this strong association remains to be determined by future longitudinal studies. In the interim, the take-home message from this meta-analysis is that it’s useful to screen women with breast cancer for autoimmune thyroid disease, Dr. Prue Hardefeldt observed at the San Antonio Breast Cancer Symposium.

The pooled analysis demonstrated that breast cancer patients were 2.92-fold more likely to have autoimmune thyroiditis than controls without breast disease. In addition, they were 2.02-fold more likely to be positive for antithyroid antibodies, and they had a 2.26-fold greater prevalence of goiter, according to Dr. Hardefeldt of the Whitely-Martin Research Center at the University of Sydney.

Breast cancer patients were also 50%-80% more likely than other women to be either hyper- or hypothyroid; however, these trends didn’t achieve statistical significance.

She declared having no financial conflicts.

SAN ANTONIO – Breast cancer patients have an increased prevalence of autoimmune thyroid disease, according to a comprehensive meta-analysis incorporating 26 published studies.

That being said, the cause of this strong association remains to be determined by future longitudinal studies. In the interim, the take-home message from this meta-analysis is that it’s useful to screen women with breast cancer for autoimmune thyroid disease, Dr. Prue Hardefeldt observed at the San Antonio Breast Cancer Symposium.

The pooled analysis demonstrated that breast cancer patients were 2.92-fold more likely to have autoimmune thyroiditis than controls without breast disease. In addition, they were 2.02-fold more likely to be positive for antithyroid antibodies, and they had a 2.26-fold greater prevalence of goiter, according to Dr. Hardefeldt of the Whitely-Martin Research Center at the University of Sydney.

Breast cancer patients were also 50%-80% more likely than other women to be either hyper- or hypothyroid; however, these trends didn’t achieve statistical significance.

She declared having no financial conflicts.

SAN ANTONIO – Breast cancer patients have an increased prevalence of autoimmune thyroid disease, according to a comprehensive meta-analysis incorporating 26 published studies.

That being said, the cause of this strong association remains to be determined by future longitudinal studies. In the interim, the take-home message from this meta-analysis is that it’s useful to screen women with breast cancer for autoimmune thyroid disease, Dr. Prue Hardefeldt observed at the San Antonio Breast Cancer Symposium.

The pooled analysis demonstrated that breast cancer patients were 2.92-fold more likely to have autoimmune thyroiditis than controls without breast disease. In addition, they were 2.02-fold more likely to be positive for antithyroid antibodies, and they had a 2.26-fold greater prevalence of goiter, according to Dr. Hardefeldt of the Whitely-Martin Research Center at the University of Sydney.

Breast cancer patients were also 50%-80% more likely than other women to be either hyper- or hypothyroid; however, these trends didn’t achieve statistical significance.

She declared having no financial conflicts.

SAN ANTONIO – BRCA mutation carriers can be separated into subgroups at low and sharply increased risks of developing contralateral breast cancer following a first breast cancer, a Dutch study suggests.

The key predictive variables identified in the BOSOM (Breast Cancer Outcome Study of Mutation) carriers were the patient’s age at diagnosis of the first breast cancer and whether or not the tumor was triple negative – that is, estrogen receptor–, progesterone receptor– and HER2 receptor–negative, Alexandra J. van den Broek reported at the annual meeting.

The BOSOM study analysis included 5,065 consecutive women diagnosed with breast cancer before age 50 at 10 Dutch hospitals during 1970-2003, all of whom were tested for BRCA mutations. The prevalence of BRCA1 mutations was 3%, while another 1% had a BRCA2 mutation.

The cumulative 10-year risk of developing contralateral breast cancer (CBC) was 6% in women with no BRCA mutations, 11% with a BRCA2 mutation, and 20% in those with a BRCA1 mutation.

The subgroup of BRCA mutation carriers at greatest risk for CBC consisted of those whose first breast cancer was diagnosed before age 41. They had a 26% rate of CBC during the next 10 years. That was nearly eightfold greater than the nearly 4% figure in the low-risk subgroup, which comprised BRCA mutation carriers with a non–triple-negative cancer diagnosed at age 41-50 years, said Ms. van den Broek, a doctoral candidate in epidemiology at the Netherlands Cancer Institute, Amsterdam.

The other high-risk subgroup of BRCA mutation carriers consisted of women with a triple-negative first breast cancer diagnosed at age 41-50 years, she added. Their 10-year cumulative risk was 15%.

The number of BRCA mutation carriers in this consecutive series of breast cancer patients was fairly small, so the BOSOM results require confirmation in other data sets. If that’s forthcoming, a change in practice guidelines for prophylaxis and screening in following breast cancer patients with a BRCA mutation will be warranted, Ms. van den Broek asserted.

The study was sponsored by the Dutch Cancer Society. Ms. van den Broek declared having no financial conflicts.

SAN ANTONIO – BRCA mutation carriers can be separated into subgroups at low and sharply increased risks of developing contralateral breast cancer following a first breast cancer, a Dutch study suggests.

The key predictive variables identified in the BOSOM (Breast Cancer Outcome Study of Mutation) carriers were the patient’s age at diagnosis of the first breast cancer and whether or not the tumor was triple negative – that is, estrogen receptor–, progesterone receptor– and HER2 receptor–negative, Alexandra J. van den Broek reported at the annual meeting.

The BOSOM study analysis included 5,065 consecutive women diagnosed with breast cancer before age 50 at 10 Dutch hospitals during 1970-2003, all of whom were tested for BRCA mutations. The prevalence of BRCA1 mutations was 3%, while another 1% had a BRCA2 mutation.

The cumulative 10-year risk of developing contralateral breast cancer (CBC) was 6% in women with no BRCA mutations, 11% with a BRCA2 mutation, and 20% in those with a BRCA1 mutation.

The subgroup of BRCA mutation carriers at greatest risk for CBC consisted of those whose first breast cancer was diagnosed before age 41. They had a 26% rate of CBC during the next 10 years. That was nearly eightfold greater than the nearly 4% figure in the low-risk subgroup, which comprised BRCA mutation carriers with a non–triple-negative cancer diagnosed at age 41-50 years, said Ms. van den Broek, a doctoral candidate in epidemiology at the Netherlands Cancer Institute, Amsterdam.

The other high-risk subgroup of BRCA mutation carriers consisted of women with a triple-negative first breast cancer diagnosed at age 41-50 years, she added. Their 10-year cumulative risk was 15%.

The number of BRCA mutation carriers in this consecutive series of breast cancer patients was fairly small, so the BOSOM results require confirmation in other data sets. If that’s forthcoming, a change in practice guidelines for prophylaxis and screening in following breast cancer patients with a BRCA mutation will be warranted, Ms. van den Broek asserted.

The study was sponsored by the Dutch Cancer Society. Ms. van den Broek declared having no financial conflicts.

SAN ANTONIO – BRCA mutation carriers can be separated into subgroups at low and sharply increased risks of developing contralateral breast cancer following a first breast cancer, a Dutch study suggests.

The key predictive variables identified in the BOSOM (Breast Cancer Outcome Study of Mutation) carriers were the patient’s age at diagnosis of the first breast cancer and whether or not the tumor was triple negative – that is, estrogen receptor–, progesterone receptor– and HER2 receptor–negative, Alexandra J. van den Broek reported at the annual meeting.

The BOSOM study analysis included 5,065 consecutive women diagnosed with breast cancer before age 50 at 10 Dutch hospitals during 1970-2003, all of whom were tested for BRCA mutations. The prevalence of BRCA1 mutations was 3%, while another 1% had a BRCA2 mutation.

The cumulative 10-year risk of developing contralateral breast cancer (CBC) was 6% in women with no BRCA mutations, 11% with a BRCA2 mutation, and 20% in those with a BRCA1 mutation.

The subgroup of BRCA mutation carriers at greatest risk for CBC consisted of those whose first breast cancer was diagnosed before age 41. They had a 26% rate of CBC during the next 10 years. That was nearly eightfold greater than the nearly 4% figure in the low-risk subgroup, which comprised BRCA mutation carriers with a non–triple-negative cancer diagnosed at age 41-50 years, said Ms. van den Broek, a doctoral candidate in epidemiology at the Netherlands Cancer Institute, Amsterdam.

The other high-risk subgroup of BRCA mutation carriers consisted of women with a triple-negative first breast cancer diagnosed at age 41-50 years, she added. Their 10-year cumulative risk was 15%.

The number of BRCA mutation carriers in this consecutive series of breast cancer patients was fairly small, so the BOSOM results require confirmation in other data sets. If that’s forthcoming, a change in practice guidelines for prophylaxis and screening in following breast cancer patients with a BRCA mutation will be warranted, Ms. van den Broek asserted.

The study was sponsored by the Dutch Cancer Society. Ms. van den Broek declared having no financial conflicts.

Most Americans aged 75 years and older continue to undergo routine screening for breast, cervical, colorectal, or prostate cancer even though recommendations advise against it, according to a report in the Dec. 12/26 issue of Archives of Internal Medicine.

Approximately half of these older adults report that their physicians recommended the cancer screening.

"These persistently elevated rates of screening raise the question of whether the decision to be screened is being made without fully knowing or discussing the risks and benefits," said Keith M. Bellizzi, Ph.D., of the department of human development and family studies, University of Connecticut, Storrs, and his associates.

According to current U.S. Preventive Services Task Force guidelines, routine screening for breast, colorectal, and prostate cancer are not advised once patients reach age 75 years, and routine screening for cervical cancer is not advised once patients reach age 65 years. "There is general agreement that screening decisions should be individualized" in this age group, based on each patient's functional status, comorbidities, life expectancy, and personal preferences.

Dr. Bellizzi and his colleagues examined real-world cancer screening practices using data from the National Health Interview Survey, an annual canvass of 30,000 households across the country that is used to monitor trends in illness. They combined data from the 2005 and 2008 surveys, resulting in a sample of 49,575 adults. A total of 1,697 of these subjects were aged 75-79 years and another 2,376 were 80 years and older.

Sixty-two percent of women aged 75-79 years and 50% of those aged 80 years and older reported that they had recently undergone mammography. Those proportions are nearly as high as the 74% rate seen in the target population for mammographic screening, women aged 50-74 years, the investigators said (Arch. Intern. Med. 2011;171:2031-7).

Similarly, 53% of women aged 75-79 years and 38% of those aged 80 years and older reported having been screened for cervical cancer.

The rate of colorectal cancer screening was actually highest (57%) in men and women aged 75-79 years, and lower (48%) in the younger age groups specified by the guidelines as the target population. The rate of colorectal cancer screening was almost as high among subjects aged 80 years and older (47%) as it was in the target population.

Similarly, the rate of PSA screening for prostate cancer was highest in the 75- to 79-year-old group (57%), followed by the oldest group (42%), and was lower in the target population of men aged 50-74 years (40%).

Patients also were asked whether their physicians had recommended cancer screening. Such a recommendation was the strongest predictor of obtaining the screening.

As many as 62% of women aged 75-79 years said that their physicians had advised them to get mammograms; 48% of that population reported that they were advised to be screened for cervical cancer. As many as 65% of older men and women said their physicians had recommended colonoscopy, including 54% of those aged 80 years and older. And as many as 62% of older men said their physicians had advised them to get PSA testing.

"This finding reinforces the critical role for health care providers to make informed screening decisions for older adults," Dr. Bellizzi and his associates said.

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

Dr. Walter’s work is supported by the National Cancer Institute and the San Francisco Veterans Affairs Medical Center. She reported no financial conflicts of interest.

Most Americans aged 75 years and older continue to undergo routine screening for breast, cervical, colorectal, or prostate cancer even though recommendations advise against it, according to a report in the Dec. 12/26 issue of Archives of Internal Medicine.

Approximately half of these older adults report that their physicians recommended the cancer screening.

"These persistently elevated rates of screening raise the question of whether the decision to be screened is being made without fully knowing or discussing the risks and benefits," said Keith M. Bellizzi, Ph.D., of the department of human development and family studies, University of Connecticut, Storrs, and his associates.

According to current U.S. Preventive Services Task Force guidelines, routine screening for breast, colorectal, and prostate cancer are not advised once patients reach age 75 years, and routine screening for cervical cancer is not advised once patients reach age 65 years. "There is general agreement that screening decisions should be individualized" in this age group, based on each patient's functional status, comorbidities, life expectancy, and personal preferences.

Dr. Bellizzi and his colleagues examined real-world cancer screening practices using data from the National Health Interview Survey, an annual canvass of 30,000 households across the country that is used to monitor trends in illness. They combined data from the 2005 and 2008 surveys, resulting in a sample of 49,575 adults. A total of 1,697 of these subjects were aged 75-79 years and another 2,376 were 80 years and older.

Sixty-two percent of women aged 75-79 years and 50% of those aged 80 years and older reported that they had recently undergone mammography. Those proportions are nearly as high as the 74% rate seen in the target population for mammographic screening, women aged 50-74 years, the investigators said (Arch. Intern. Med. 2011;171:2031-7).

Similarly, 53% of women aged 75-79 years and 38% of those aged 80 years and older reported having been screened for cervical cancer.

The rate of colorectal cancer screening was actually highest (57%) in men and women aged 75-79 years, and lower (48%) in the younger age groups specified by the guidelines as the target population. The rate of colorectal cancer screening was almost as high among subjects aged 80 years and older (47%) as it was in the target population.

Similarly, the rate of PSA screening for prostate cancer was highest in the 75- to 79-year-old group (57%), followed by the oldest group (42%), and was lower in the target population of men aged 50-74 years (40%).

Patients also were asked whether their physicians had recommended cancer screening. Such a recommendation was the strongest predictor of obtaining the screening.

As many as 62% of women aged 75-79 years said that their physicians had advised them to get mammograms; 48% of that population reported that they were advised to be screened for cervical cancer. As many as 65% of older men and women said their physicians had recommended colonoscopy, including 54% of those aged 80 years and older. And as many as 62% of older men said their physicians had advised them to get PSA testing.

"This finding reinforces the critical role for health care providers to make informed screening decisions for older adults," Dr. Bellizzi and his associates said.

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

Dr. Walter’s work is supported by the National Cancer Institute and the San Francisco Veterans Affairs Medical Center. She reported no financial conflicts of interest.

Most Americans aged 75 years and older continue to undergo routine screening for breast, cervical, colorectal, or prostate cancer even though recommendations advise against it, according to a report in the Dec. 12/26 issue of Archives of Internal Medicine.

Approximately half of these older adults report that their physicians recommended the cancer screening.

"These persistently elevated rates of screening raise the question of whether the decision to be screened is being made without fully knowing or discussing the risks and benefits," said Keith M. Bellizzi, Ph.D., of the department of human development and family studies, University of Connecticut, Storrs, and his associates.

According to current U.S. Preventive Services Task Force guidelines, routine screening for breast, colorectal, and prostate cancer are not advised once patients reach age 75 years, and routine screening for cervical cancer is not advised once patients reach age 65 years. "There is general agreement that screening decisions should be individualized" in this age group, based on each patient's functional status, comorbidities, life expectancy, and personal preferences.

Dr. Bellizzi and his colleagues examined real-world cancer screening practices using data from the National Health Interview Survey, an annual canvass of 30,000 households across the country that is used to monitor trends in illness. They combined data from the 2005 and 2008 surveys, resulting in a sample of 49,575 adults. A total of 1,697 of these subjects were aged 75-79 years and another 2,376 were 80 years and older.

Sixty-two percent of women aged 75-79 years and 50% of those aged 80 years and older reported that they had recently undergone mammography. Those proportions are nearly as high as the 74% rate seen in the target population for mammographic screening, women aged 50-74 years, the investigators said (Arch. Intern. Med. 2011;171:2031-7).

Similarly, 53% of women aged 75-79 years and 38% of those aged 80 years and older reported having been screened for cervical cancer.

The rate of colorectal cancer screening was actually highest (57%) in men and women aged 75-79 years, and lower (48%) in the younger age groups specified by the guidelines as the target population. The rate of colorectal cancer screening was almost as high among subjects aged 80 years and older (47%) as it was in the target population.

Similarly, the rate of PSA screening for prostate cancer was highest in the 75- to 79-year-old group (57%), followed by the oldest group (42%), and was lower in the target population of men aged 50-74 years (40%).

Patients also were asked whether their physicians had recommended cancer screening. Such a recommendation was the strongest predictor of obtaining the screening.

As many as 62% of women aged 75-79 years said that their physicians had advised them to get mammograms; 48% of that population reported that they were advised to be screened for cervical cancer. As many as 65% of older men and women said their physicians had recommended colonoscopy, including 54% of those aged 80 years and older. And as many as 62% of older men said their physicians had advised them to get PSA testing.

"This finding reinforces the critical role for health care providers to make informed screening decisions for older adults," Dr. Bellizzi and his associates said.

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

Dr. Walter’s work is supported by the National Cancer Institute and the San Francisco Veterans Affairs Medical Center. She reported no financial conflicts of interest.

SAN ANTONIO – Bilateral oophorectomy in women younger than age 45 is associated with a subsequent doubled prevalence of osteoporosis and a similarly elevated rate of arthritis, compared with women with intact ovaries.

These findings from a new analysis of the Third National Health and Nutrition Examination Survey (NHANES III) had a further twist: The likelihood of having low bone mineral density and/or arthritis was even greater in the subgroup of women not on hormone replacement therapy following their surgically-induced abrupt menopause, Anne Marie McCarthy said at the San Antonio Breast Cancer Symposium.

"The implication of our findings is that women who’ve had their ovaries removed at a young age can now be informed about their risk for bone loss over the long term. However, additional studies are needed to determine the frequency of monitoring for osteoporosis and the appropriateness of various preventive strategies in women who’ve had their ovaries removed," according to Ms. McCarthy, a doctoral candidate in epidemiology at Johns Hopkins University, Baltimore.

The bone mineral density analysis included 3,660 women who underwent femoral neck bone density measurement by dual energy x-ray as part of their participation in NHANES III, which was conducted in a U.S. nationally representative sample in 1988-1994.

The age-standardized mean femoral neck bone density was significantly lower in women with oophorectomy before age 45 than in those with intact ovaries: 0.711 compared with 0.743 g/m² (P = .017). Moreover, in a multivariate logistic regression analysis, women with early oophorectomy had an adjusted 1.78-fold increased likelihood of having osteoporosis, compared with women with intact ovaries. Upon exclusion of hormone replacement therapy users, the odds climbed even higher so that oophorectomy before age 45 was associated with a 2.92-fold increased likelihood of osteoporosis, she reported.

The Johns Hopkins investigators are now in the midst of a study in which they’re measuring bone mineral density before and after prophylactic oophorectomy in women who carry high-risk BRCA mutations.

The arthritis analysis included 4,039 women. Those who had undergone oophorectomy were significantly more likely to report having been informed by a physician that they have arthritis, by a margin of 45.4% to 32.1% (P less than .001). Among the subset of women with oophorectomy before age 45, the prevalence of arthritis was even higher at 47.7%. In a multivariate analysis, women with oophorectomy when they were younger than 45 had a 1.78-fold increased odds of arthritis compared with those with intact ovaries. If they didn’t use hormone replacement therapy, however, those odds rose to 1.99-fold.

Because the investigators didn’t study the NHANES III participants’ actual medical records, they were unable to say what specific forms of arthritis were more prevalent in the early oophorectomy group. Also, since to Ms. McCarthy’s knowledge this is the first-ever study linking oophorectomy to arthritis, this association needs confirmation by others. There are animal data supporting such a link, she noted.

"One possible mechanism is that we think estrogen is important for the health of cartilage, so losing estrogen can lead to inflammation and damage of cartilage, perhaps," Ms. McCarthy speculated.

Prophylactic bilateral oophorectomy is a widely accepted procedure to reduce the risks of breast and ovarian cancer in BRCA mutation carriers. But this indication actually accounts for only a small fraction of oophorectomies performed in this country. About 600,000 women per year undergo hysterectomy for indications including fibroids, abnormal bleeding, endometriosis, and uterine prolapse, according to the Centers for Disease Control and Prevention, and about half of them have both ovaries removed at that time to prevent ovarian cancer.

NHANES III was conducted by the CDC. Ms. McCarthy said she had no relevant financial disclosures.

SAN ANTONIO – Bilateral oophorectomy in women younger than age 45 is associated with a subsequent doubled prevalence of osteoporosis and a similarly elevated rate of arthritis, compared with women with intact ovaries.

These findings from a new analysis of the Third National Health and Nutrition Examination Survey (NHANES III) had a further twist: The likelihood of having low bone mineral density and/or arthritis was even greater in the subgroup of women not on hormone replacement therapy following their surgically-induced abrupt menopause, Anne Marie McCarthy said at the San Antonio Breast Cancer Symposium.

"The implication of our findings is that women who’ve had their ovaries removed at a young age can now be informed about their risk for bone loss over the long term. However, additional studies are needed to determine the frequency of monitoring for osteoporosis and the appropriateness of various preventive strategies in women who’ve had their ovaries removed," according to Ms. McCarthy, a doctoral candidate in epidemiology at Johns Hopkins University, Baltimore.

The bone mineral density analysis included 3,660 women who underwent femoral neck bone density measurement by dual energy x-ray as part of their participation in NHANES III, which was conducted in a U.S. nationally representative sample in 1988-1994.

The age-standardized mean femoral neck bone density was significantly lower in women with oophorectomy before age 45 than in those with intact ovaries: 0.711 compared with 0.743 g/m² (P = .017). Moreover, in a multivariate logistic regression analysis, women with early oophorectomy had an adjusted 1.78-fold increased likelihood of having osteoporosis, compared with women with intact ovaries. Upon exclusion of hormone replacement therapy users, the odds climbed even higher so that oophorectomy before age 45 was associated with a 2.92-fold increased likelihood of osteoporosis, she reported.

The Johns Hopkins investigators are now in the midst of a study in which they’re measuring bone mineral density before and after prophylactic oophorectomy in women who carry high-risk BRCA mutations.

The arthritis analysis included 4,039 women. Those who had undergone oophorectomy were significantly more likely to report having been informed by a physician that they have arthritis, by a margin of 45.4% to 32.1% (P less than .001). Among the subset of women with oophorectomy before age 45, the prevalence of arthritis was even higher at 47.7%. In a multivariate analysis, women with oophorectomy when they were younger than 45 had a 1.78-fold increased odds of arthritis compared with those with intact ovaries. If they didn’t use hormone replacement therapy, however, those odds rose to 1.99-fold.

Because the investigators didn’t study the NHANES III participants’ actual medical records, they were unable to say what specific forms of arthritis were more prevalent in the early oophorectomy group. Also, since to Ms. McCarthy’s knowledge this is the first-ever study linking oophorectomy to arthritis, this association needs confirmation by others. There are animal data supporting such a link, she noted.

"One possible mechanism is that we think estrogen is important for the health of cartilage, so losing estrogen can lead to inflammation and damage of cartilage, perhaps," Ms. McCarthy speculated.

Prophylactic bilateral oophorectomy is a widely accepted procedure to reduce the risks of breast and ovarian cancer in BRCA mutation carriers. But this indication actually accounts for only a small fraction of oophorectomies performed in this country. About 600,000 women per year undergo hysterectomy for indications including fibroids, abnormal bleeding, endometriosis, and uterine prolapse, according to the Centers for Disease Control and Prevention, and about half of them have both ovaries removed at that time to prevent ovarian cancer.

NHANES III was conducted by the CDC. Ms. McCarthy said she had no relevant financial disclosures.

SAN ANTONIO – Bilateral oophorectomy in women younger than age 45 is associated with a subsequent doubled prevalence of osteoporosis and a similarly elevated rate of arthritis, compared with women with intact ovaries.

These findings from a new analysis of the Third National Health and Nutrition Examination Survey (NHANES III) had a further twist: The likelihood of having low bone mineral density and/or arthritis was even greater in the subgroup of women not on hormone replacement therapy following their surgically-induced abrupt menopause, Anne Marie McCarthy said at the San Antonio Breast Cancer Symposium.

"The implication of our findings is that women who’ve had their ovaries removed at a young age can now be informed about their risk for bone loss over the long term. However, additional studies are needed to determine the frequency of monitoring for osteoporosis and the appropriateness of various preventive strategies in women who’ve had their ovaries removed," according to Ms. McCarthy, a doctoral candidate in epidemiology at Johns Hopkins University, Baltimore.

The bone mineral density analysis included 3,660 women who underwent femoral neck bone density measurement by dual energy x-ray as part of their participation in NHANES III, which was conducted in a U.S. nationally representative sample in 1988-1994.

The age-standardized mean femoral neck bone density was significantly lower in women with oophorectomy before age 45 than in those with intact ovaries: 0.711 compared with 0.743 g/m² (P = .017). Moreover, in a multivariate logistic regression analysis, women with early oophorectomy had an adjusted 1.78-fold increased likelihood of having osteoporosis, compared with women with intact ovaries. Upon exclusion of hormone replacement therapy users, the odds climbed even higher so that oophorectomy before age 45 was associated with a 2.92-fold increased likelihood of osteoporosis, she reported.

The Johns Hopkins investigators are now in the midst of a study in which they’re measuring bone mineral density before and after prophylactic oophorectomy in women who carry high-risk BRCA mutations.

The arthritis analysis included 4,039 women. Those who had undergone oophorectomy were significantly more likely to report having been informed by a physician that they have arthritis, by a margin of 45.4% to 32.1% (P less than .001). Among the subset of women with oophorectomy before age 45, the prevalence of arthritis was even higher at 47.7%. In a multivariate analysis, women with oophorectomy when they were younger than 45 had a 1.78-fold increased odds of arthritis compared with those with intact ovaries. If they didn’t use hormone replacement therapy, however, those odds rose to 1.99-fold.

Because the investigators didn’t study the NHANES III participants’ actual medical records, they were unable to say what specific forms of arthritis were more prevalent in the early oophorectomy group. Also, since to Ms. McCarthy’s knowledge this is the first-ever study linking oophorectomy to arthritis, this association needs confirmation by others. There are animal data supporting such a link, she noted.

"One possible mechanism is that we think estrogen is important for the health of cartilage, so losing estrogen can lead to inflammation and damage of cartilage, perhaps," Ms. McCarthy speculated.

Prophylactic bilateral oophorectomy is a widely accepted procedure to reduce the risks of breast and ovarian cancer in BRCA mutation carriers. But this indication actually accounts for only a small fraction of oophorectomies performed in this country. About 600,000 women per year undergo hysterectomy for indications including fibroids, abnormal bleeding, endometriosis, and uterine prolapse, according to the Centers for Disease Control and Prevention, and about half of them have both ovaries removed at that time to prevent ovarian cancer.

NHANES III was conducted by the CDC. Ms. McCarthy said she had no relevant financial disclosures.

SAN ANTONIO – Treatment with atorvastatin did not significantly change mammographic density after 1 year in a small randomized phase III study of premenopausal women at high risk for breast cancer.

While statins are widely used to prevent cardiovascular disease, it has been suggested that these drugs also may have a role in breast cancer prevention. Statin users are estimated to have a 30%-70% lower incidence of breast cancer, compared with nonusers, according to Dr. Marie E. Wood, professor of medicine and director of the familial cancer program at the University of Vermont, Burlington, and her coinvestigators.

A total of 63 premenopausal women were randomized to receive either 40 mg of atorvastatin (Lipitor) or placebo daily for a year. At the end of that time the investigators found no association between change in breast density and atorvastatin use in a multivariable linear regression analysis adjusted for age and body mass index. The data were presented in poster form at the San Antonio Breast Cancer Symposium.

The women had a mean age of 44 years and a mean body mass index (BMI) of 26.4 kg/m². Mammographic density was assessed using the Breast Imaging Reporting and Data System (BI-RADS), which is a standardized qualitative assessment of mammographic breast density with four categories.

Four percent of women had fatty-replaced breast tissue, 29% had scattered fibroglandular densities, 56% had heterogeneously dense breasts, and 11% had extremely dense breast tissue.

A total of 26% of women withdrew from the study – four because of side effects (headache, back pain, joint pain), six because of abnormal laboratory values, and the remainder for other reasons.

Baseline to 12-month changes in breast density were measured in all patients on a continuous scale using the visual analog scale method. Mean density at study entry was 31.6% and 32.4% at the end of treatment. Because of the skewed distribution of breast density change, a Wilcoxon signed-rank test was performed to determine if the change in breast density varied with treatment. No statistically significant difference was observed between the two treatment groups (P = .89).

Premenopausal women with regular menstrual cycles (four cycles in past 6 months) were eligible if they were at least 35 years of age and at increased risk of developing breast cancer. Increased risk was defined as having at least one of the following: a prior biopsy demonstrating atypical hyperplasia or lobular carcinoma in situ; BRCA1/2 mutation carrier (or mutation is in a family member); 5-year Gail Model Risk of greater than1.66%; a strong family history of breast and/or ovarian cancer; a prior history of breast cancer (ductal carcinoma in situ and stage 0-IIIb) and at least 1 year off of all therapy; and a history of chemoradiotherapy treatment for Hodgkin’s disease.

Women were excluded if they had a history of stage IV breast cancer or ovarian cancer; were already taking statins; were taking HRT, tamoxifen, raloxifene, an aromatase inhibitor; or were participating in another chemoprevention trial.

The researchers urged caution in interpreting the data, given the small sample size, slow accrual, wide variation in the mammographic density in this population, and the fact that mammograms were done during the transition to digital mammography.

"While the primary aim of this study was not met, we have shown that biomarker studies can be done in a multi-institutional setting ... Additional biomarker evaluation may prove informative," they wrote

Dr. Wood and her associates are currently analyzing the effect of a daily statin vs. placebo on markers of breast cancer risk, including mammographic density, serum markers (IGF-1), and tissue markers (atypia and Ki67).

This study is sponsored by the Breast Cancer Research Foundation and the Cancer and Leukemia Group B. The researchers reported that they have no relevant disclosures.

SAN ANTONIO – Treatment with atorvastatin did not significantly change mammographic density after 1 year in a small randomized phase III study of premenopausal women at high risk for breast cancer.

While statins are widely used to prevent cardiovascular disease, it has been suggested that these drugs also may have a role in breast cancer prevention. Statin users are estimated to have a 30%-70% lower incidence of breast cancer, compared with nonusers, according to Dr. Marie E. Wood, professor of medicine and director of the familial cancer program at the University of Vermont, Burlington, and her coinvestigators.

A total of 63 premenopausal women were randomized to receive either 40 mg of atorvastatin (Lipitor) or placebo daily for a year. At the end of that time the investigators found no association between change in breast density and atorvastatin use in a multivariable linear regression analysis adjusted for age and body mass index. The data were presented in poster form at the San Antonio Breast Cancer Symposium.

The women had a mean age of 44 years and a mean body mass index (BMI) of 26.4 kg/m². Mammographic density was assessed using the Breast Imaging Reporting and Data System (BI-RADS), which is a standardized qualitative assessment of mammographic breast density with four categories.

Four percent of women had fatty-replaced breast tissue, 29% had scattered fibroglandular densities, 56% had heterogeneously dense breasts, and 11% had extremely dense breast tissue.

A total of 26% of women withdrew from the study – four because of side effects (headache, back pain, joint pain), six because of abnormal laboratory values, and the remainder for other reasons.

Baseline to 12-month changes in breast density were measured in all patients on a continuous scale using the visual analog scale method. Mean density at study entry was 31.6% and 32.4% at the end of treatment. Because of the skewed distribution of breast density change, a Wilcoxon signed-rank test was performed to determine if the change in breast density varied with treatment. No statistically significant difference was observed between the two treatment groups (P = .89).

Premenopausal women with regular menstrual cycles (four cycles in past 6 months) were eligible if they were at least 35 years of age and at increased risk of developing breast cancer. Increased risk was defined as having at least one of the following: a prior biopsy demonstrating atypical hyperplasia or lobular carcinoma in situ; BRCA1/2 mutation carrier (or mutation is in a family member); 5-year Gail Model Risk of greater than1.66%; a strong family history of breast and/or ovarian cancer; a prior history of breast cancer (ductal carcinoma in situ and stage 0-IIIb) and at least 1 year off of all therapy; and a history of chemoradiotherapy treatment for Hodgkin’s disease.

Women were excluded if they had a history of stage IV breast cancer or ovarian cancer; were already taking statins; were taking HRT, tamoxifen, raloxifene, an aromatase inhibitor; or were participating in another chemoprevention trial.

The researchers urged caution in interpreting the data, given the small sample size, slow accrual, wide variation in the mammographic density in this population, and the fact that mammograms were done during the transition to digital mammography.

"While the primary aim of this study was not met, we have shown that biomarker studies can be done in a multi-institutional setting ... Additional biomarker evaluation may prove informative," they wrote

Dr. Wood and her associates are currently analyzing the effect of a daily statin vs. placebo on markers of breast cancer risk, including mammographic density, serum markers (IGF-1), and tissue markers (atypia and Ki67).

This study is sponsored by the Breast Cancer Research Foundation and the Cancer and Leukemia Group B. The researchers reported that they have no relevant disclosures.

SAN ANTONIO – Treatment with atorvastatin did not significantly change mammographic density after 1 year in a small randomized phase III study of premenopausal women at high risk for breast cancer.

While statins are widely used to prevent cardiovascular disease, it has been suggested that these drugs also may have a role in breast cancer prevention. Statin users are estimated to have a 30%-70% lower incidence of breast cancer, compared with nonusers, according to Dr. Marie E. Wood, professor of medicine and director of the familial cancer program at the University of Vermont, Burlington, and her coinvestigators.

A total of 63 premenopausal women were randomized to receive either 40 mg of atorvastatin (Lipitor) or placebo daily for a year. At the end of that time the investigators found no association between change in breast density and atorvastatin use in a multivariable linear regression analysis adjusted for age and body mass index. The data were presented in poster form at the San Antonio Breast Cancer Symposium.

The women had a mean age of 44 years and a mean body mass index (BMI) of 26.4 kg/m². Mammographic density was assessed using the Breast Imaging Reporting and Data System (BI-RADS), which is a standardized qualitative assessment of mammographic breast density with four categories.

Four percent of women had fatty-replaced breast tissue, 29% had scattered fibroglandular densities, 56% had heterogeneously dense breasts, and 11% had extremely dense breast tissue.

A total of 26% of women withdrew from the study – four because of side effects (headache, back pain, joint pain), six because of abnormal laboratory values, and the remainder for other reasons.

Baseline to 12-month changes in breast density were measured in all patients on a continuous scale using the visual analog scale method. Mean density at study entry was 31.6% and 32.4% at the end of treatment. Because of the skewed distribution of breast density change, a Wilcoxon signed-rank test was performed to determine if the change in breast density varied with treatment. No statistically significant difference was observed between the two treatment groups (P = .89).

Premenopausal women with regular menstrual cycles (four cycles in past 6 months) were eligible if they were at least 35 years of age and at increased risk of developing breast cancer. Increased risk was defined as having at least one of the following: a prior biopsy demonstrating atypical hyperplasia or lobular carcinoma in situ; BRCA1/2 mutation carrier (or mutation is in a family member); 5-year Gail Model Risk of greater than1.66%; a strong family history of breast and/or ovarian cancer; a prior history of breast cancer (ductal carcinoma in situ and stage 0-IIIb) and at least 1 year off of all therapy; and a history of chemoradiotherapy treatment for Hodgkin’s disease.

Women were excluded if they had a history of stage IV breast cancer or ovarian cancer; were already taking statins; were taking HRT, tamoxifen, raloxifene, an aromatase inhibitor; or were participating in another chemoprevention trial.

The researchers urged caution in interpreting the data, given the small sample size, slow accrual, wide variation in the mammographic density in this population, and the fact that mammograms were done during the transition to digital mammography.

"While the primary aim of this study was not met, we have shown that biomarker studies can be done in a multi-institutional setting ... Additional biomarker evaluation may prove informative," they wrote

Dr. Wood and her associates are currently analyzing the effect of a daily statin vs. placebo on markers of breast cancer risk, including mammographic density, serum markers (IGF-1), and tissue markers (atypia and Ki67).

This study is sponsored by the Breast Cancer Research Foundation and the Cancer and Leukemia Group B. The researchers reported that they have no relevant disclosures.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.

SAN ANTONIO – A phase III trial of an adjuvant breast cancer vaccine will begin enrollment before the end of 2011 as a result of favorable 5-year efficacy and safety data in a phase II study.

In updated phase II results, disease-free survival at a median follow-up of 60 months was 95.9% in 53 patients who received the E75 vaccine with multiple booster inoculations, significantly better than the 79.7% figure in 79 controls (P = .016), Dr. Timothy J. Vreeland reported at the San Antonio Breast Cancer Symposium.

The vaccine, known as NeuVax, is composed of the E75 peptide, which is derived from human epidermal growth factor receptor 2 (HER2), mixed with granulocyte macrophage colony-stimulating factor (GM-CSF). The vaccine has previously been shown to stimulate cytotoxic T cells to specifically target cells expressing HER2.

As a result of lessons learned in the randomized phase II study, the phase III trial will be restricted to patients with lymph node–positive tumors who are clinically disease-free after completing standard therapy. Only patients with low levels of HER2 expression, meaning immunohistochemistry 1+ or 2+, will be eligible.

The E75 vaccine was initially given as an intradermal injection once a month for 6 months. Because of waning immunity noted during phase I and II testing, however, a booster immunization program was initiated. It consists of a booster injection once every 6 months. The booster program will be routine in the phase III trial.

The overall phase II study population consisted of 187 patients with node-positive or high-risk node-negative tumors expressing any level of HER2. The median 5-year disease-free survival in the 108 patients in the vaccine arm was 89.4%, compared with 79.7% in controls, a nonsignificant difference. But the vaccine arm included 55 women who didn’t receive booster immunizations. When they were excluded, the 5-year disease-free survival rate climbed to 95.9%, according to Dr. Vreeland, a U.S. Army captain at San Antonio Military Medical Center.

The E75 vaccine has been very well tolerated. A total of 70%-85% of local and systemic toxicities in both the primary vaccination series and the booster inoculations have been grade I, with the remainder grade II. Seven of 53 patients (13%) in the booster program developed grade II delayed urticarial reactions at a median of 9 days post inoculation.

The phase III trial is called PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment).

The NeuVax vaccine has been licensed by the U.S. military to Galena Biopharma. Dr. Vreeland declared having no relevant financial disclosures.

SAN ANTONIO – A phase III trial of an adjuvant breast cancer vaccine will begin enrollment before the end of 2011 as a result of favorable 5-year efficacy and safety data in a phase II study.

In updated phase II results, disease-free survival at a median follow-up of 60 months was 95.9% in 53 patients who received the E75 vaccine with multiple booster inoculations, significantly better than the 79.7% figure in 79 controls (P = .016), Dr. Timothy J. Vreeland reported at the San Antonio Breast Cancer Symposium.

The vaccine, known as NeuVax, is composed of the E75 peptide, which is derived from human epidermal growth factor receptor 2 (HER2), mixed with granulocyte macrophage colony-stimulating factor (GM-CSF). The vaccine has previously been shown to stimulate cytotoxic T cells to specifically target cells expressing HER2.

As a result of lessons learned in the randomized phase II study, the phase III trial will be restricted to patients with lymph node–positive tumors who are clinically disease-free after completing standard therapy. Only patients with low levels of HER2 expression, meaning immunohistochemistry 1+ or 2+, will be eligible.

The E75 vaccine was initially given as an intradermal injection once a month for 6 months. Because of waning immunity noted during phase I and II testing, however, a booster immunization program was initiated. It consists of a booster injection once every 6 months. The booster program will be routine in the phase III trial.

The overall phase II study population consisted of 187 patients with node-positive or high-risk node-negative tumors expressing any level of HER2. The median 5-year disease-free survival in the 108 patients in the vaccine arm was 89.4%, compared with 79.7% in controls, a nonsignificant difference. But the vaccine arm included 55 women who didn’t receive booster immunizations. When they were excluded, the 5-year disease-free survival rate climbed to 95.9%, according to Dr. Vreeland, a U.S. Army captain at San Antonio Military Medical Center.

The E75 vaccine has been very well tolerated. A total of 70%-85% of local and systemic toxicities in both the primary vaccination series and the booster inoculations have been grade I, with the remainder grade II. Seven of 53 patients (13%) in the booster program developed grade II delayed urticarial reactions at a median of 9 days post inoculation.

The phase III trial is called PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment).

The NeuVax vaccine has been licensed by the U.S. military to Galena Biopharma. Dr. Vreeland declared having no relevant financial disclosures.

SAN ANTONIO – A phase III trial of an adjuvant breast cancer vaccine will begin enrollment before the end of 2011 as a result of favorable 5-year efficacy and safety data in a phase II study.

In updated phase II results, disease-free survival at a median follow-up of 60 months was 95.9% in 53 patients who received the E75 vaccine with multiple booster inoculations, significantly better than the 79.7% figure in 79 controls (P = .016), Dr. Timothy J. Vreeland reported at the San Antonio Breast Cancer Symposium.

The vaccine, known as NeuVax, is composed of the E75 peptide, which is derived from human epidermal growth factor receptor 2 (HER2), mixed with granulocyte macrophage colony-stimulating factor (GM-CSF). The vaccine has previously been shown to stimulate cytotoxic T cells to specifically target cells expressing HER2.

As a result of lessons learned in the randomized phase II study, the phase III trial will be restricted to patients with lymph node–positive tumors who are clinically disease-free after completing standard therapy. Only patients with low levels of HER2 expression, meaning immunohistochemistry 1+ or 2+, will be eligible.

The E75 vaccine was initially given as an intradermal injection once a month for 6 months. Because of waning immunity noted during phase I and II testing, however, a booster immunization program was initiated. It consists of a booster injection once every 6 months. The booster program will be routine in the phase III trial.

The overall phase II study population consisted of 187 patients with node-positive or high-risk node-negative tumors expressing any level of HER2. The median 5-year disease-free survival in the 108 patients in the vaccine arm was 89.4%, compared with 79.7% in controls, a nonsignificant difference. But the vaccine arm included 55 women who didn’t receive booster immunizations. When they were excluded, the 5-year disease-free survival rate climbed to 95.9%, according to Dr. Vreeland, a U.S. Army captain at San Antonio Military Medical Center.

The E75 vaccine has been very well tolerated. A total of 70%-85% of local and systemic toxicities in both the primary vaccination series and the booster inoculations have been grade I, with the remainder grade II. Seven of 53 patients (13%) in the booster program developed grade II delayed urticarial reactions at a median of 9 days post inoculation.

The phase III trial is called PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment).

The NeuVax vaccine has been licensed by the U.S. military to Galena Biopharma. Dr. Vreeland declared having no relevant financial disclosures.

SAN ANTONIO – Axillary lymph node dissection is not warranted in patients with clinically node-negative breast cancer and micrometastases in the sentinel node, another randomized phase III clinical trial has found.

New 57-month follow-up data from the International Breast Cancer Study Group (IBCSG) trial 23-01 in breast cancer patients with minimal sentinel node involvement show no disease-free or overall survival differences between patients who underwent axillary dissection and those who did not, Dr. Viviana Galimberti reported at the San Antonio Breast Cancer Symposium.

This is consistent with the results of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, which reported in February that it found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection and those who did not after being found sentinel node positive on biopsy (JAMA 2011;305:569-75).

The IBCSG trial 23-01 randomized 934 patients from 27 centers to axillary dissection or no further axillary surgery. All of the patients had tumors no larger than 5 cm and minimal sentinel node involvement, defined as one or more micrometastatic (less than 2 mm) sentinel node were included in the analysis, said Dr. Galimberti of the European Institute of Oncology in Milan. Disease-free survival was the study’s primary end point, while overall survival and systemic disease-free survival were secondary end points, she said.

Of the 934 patients, 3 were excluded, including 2 patients in whom no tumor was found in the sentinel node and 1 patient who withdrew consent, Dr. Galimberti said. Of the remaining 931 patients in the intent to treat population, 17 of the 464 assigned to axial dissection did not receive it and 14 of the 467 assigned to no dissection did receive it, she said.

At study entry, mean patient age was 54 years, and more than half (56%) of the patients were postmenopausal. Regarding disease characteristics, 67% of the patients had tumors less than 2 cm, 7% had tumors 3 cm or larger, and 26% had grade 3 disease "Most of the tumors [89%] were estrogen receptor–positive and 75% were progesterone receptor–positive," Dr. Galimberti said. In the involved sentinel nodes, 67% of the patients had micrometastasis less than 1.0 mm, 29% had micrometastasis from 1.1-2.0, 2% had metastasis greater than 2.0, and 2% were unknown, she said.

In all, 96% of the patients underwent lymphoscintigraphy and evidence of one or two sentinel nodes was found in 85% of them, Dr. Galimberti reported. Previous excision biopsy was performed in 16% of the patients, and conservative surgery was the definitive treatment in three-quarters of the patients while 25% received mastectomy. Similar rates of adjuvant radiotherapy, hormonal therapy, and chemotherapy were seen in both groups, she said.

Long-term adverse events were more prevalent in the dissection group, with 18% experiencing sensory neuropathy, compared with 12% of those not undergoing dissection. Similarly, the respective rates of lymphedema were 13% and 4% and the respective rates of motor neuropathy were 8% and 3%, Dr. Galimberti reported.

The 5-year disease-free survival rates in the dissection and no dissection groups were 87.3% and 88.4%, respectively, said Dr. Galimberti. The 5-year overall survival rates were similar between both groups as well, at 97.6% in the dissection group and 98% in the no-dissection group.

"In total, there were 17 [3.7%] deaths among the patients who underwent dissection and 12 [2.6%] among those who did not," she said.

The lack of a difference between the groups for the primary end point of disease-free survival fulfilled the protocol-specified criterion for noninferiority. Indeed, Dr. Galimberti noted, "The 5-year disease-free survival of 88% in the patients who did not undergo dissection was much better than the 70% that was anticipated in the original plan," she said. The rate of reappearance of tumor in the undissected axilla was also unexpectedly low, at about 1%, she added.

"It seems likely that the results of the IBCSG Trial 23-01 and Z0011 will change clinical practice, allowing no axillary dissection in early breast cancer, especially when the sentinel node is minimally involved, to reduce [associated] complications with no adverse effect on survival," Dr. Galimberti concluded.

Dr. Galimberti reported having no relevant financial conflicts to disclose.

SAN ANTONIO – Axillary lymph node dissection is not warranted in patients with clinically node-negative breast cancer and micrometastases in the sentinel node, another randomized phase III clinical trial has found.

New 57-month follow-up data from the International Breast Cancer Study Group (IBCSG) trial 23-01 in breast cancer patients with minimal sentinel node involvement show no disease-free or overall survival differences between patients who underwent axillary dissection and those who did not, Dr. Viviana Galimberti reported at the San Antonio Breast Cancer Symposium.

This is consistent with the results of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, which reported in February that it found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection and those who did not after being found sentinel node positive on biopsy (JAMA 2011;305:569-75).

The IBCSG trial 23-01 randomized 934 patients from 27 centers to axillary dissection or no further axillary surgery. All of the patients had tumors no larger than 5 cm and minimal sentinel node involvement, defined as one or more micrometastatic (less than 2 mm) sentinel node were included in the analysis, said Dr. Galimberti of the European Institute of Oncology in Milan. Disease-free survival was the study’s primary end point, while overall survival and systemic disease-free survival were secondary end points, she said.

Of the 934 patients, 3 were excluded, including 2 patients in whom no tumor was found in the sentinel node and 1 patient who withdrew consent, Dr. Galimberti said. Of the remaining 931 patients in the intent to treat population, 17 of the 464 assigned to axial dissection did not receive it and 14 of the 467 assigned to no dissection did receive it, she said.

At study entry, mean patient age was 54 years, and more than half (56%) of the patients were postmenopausal. Regarding disease characteristics, 67% of the patients had tumors less than 2 cm, 7% had tumors 3 cm or larger, and 26% had grade 3 disease "Most of the tumors [89%] were estrogen receptor–positive and 75% were progesterone receptor–positive," Dr. Galimberti said. In the involved sentinel nodes, 67% of the patients had micrometastasis less than 1.0 mm, 29% had micrometastasis from 1.1-2.0, 2% had metastasis greater than 2.0, and 2% were unknown, she said.

In all, 96% of the patients underwent lymphoscintigraphy and evidence of one or two sentinel nodes was found in 85% of them, Dr. Galimberti reported. Previous excision biopsy was performed in 16% of the patients, and conservative surgery was the definitive treatment in three-quarters of the patients while 25% received mastectomy. Similar rates of adjuvant radiotherapy, hormonal therapy, and chemotherapy were seen in both groups, she said.

Long-term adverse events were more prevalent in the dissection group, with 18% experiencing sensory neuropathy, compared with 12% of those not undergoing dissection. Similarly, the respective rates of lymphedema were 13% and 4% and the respective rates of motor neuropathy were 8% and 3%, Dr. Galimberti reported.

The 5-year disease-free survival rates in the dissection and no dissection groups were 87.3% and 88.4%, respectively, said Dr. Galimberti. The 5-year overall survival rates were similar between both groups as well, at 97.6% in the dissection group and 98% in the no-dissection group.

"In total, there were 17 [3.7%] deaths among the patients who underwent dissection and 12 [2.6%] among those who did not," she said.

The lack of a difference between the groups for the primary end point of disease-free survival fulfilled the protocol-specified criterion for noninferiority. Indeed, Dr. Galimberti noted, "The 5-year disease-free survival of 88% in the patients who did not undergo dissection was much better than the 70% that was anticipated in the original plan," she said. The rate of reappearance of tumor in the undissected axilla was also unexpectedly low, at about 1%, she added.

"It seems likely that the results of the IBCSG Trial 23-01 and Z0011 will change clinical practice, allowing no axillary dissection in early breast cancer, especially when the sentinel node is minimally involved, to reduce [associated] complications with no adverse effect on survival," Dr. Galimberti concluded.

Dr. Galimberti reported having no relevant financial conflicts to disclose.

SAN ANTONIO – Axillary lymph node dissection is not warranted in patients with clinically node-negative breast cancer and micrometastases in the sentinel node, another randomized phase III clinical trial has found.

New 57-month follow-up data from the International Breast Cancer Study Group (IBCSG) trial 23-01 in breast cancer patients with minimal sentinel node involvement show no disease-free or overall survival differences between patients who underwent axillary dissection and those who did not, Dr. Viviana Galimberti reported at the San Antonio Breast Cancer Symposium.

This is consistent with the results of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, which reported in February that it found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection and those who did not after being found sentinel node positive on biopsy (JAMA 2011;305:569-75).

The IBCSG trial 23-01 randomized 934 patients from 27 centers to axillary dissection or no further axillary surgery. All of the patients had tumors no larger than 5 cm and minimal sentinel node involvement, defined as one or more micrometastatic (less than 2 mm) sentinel node were included in the analysis, said Dr. Galimberti of the European Institute of Oncology in Milan. Disease-free survival was the study’s primary end point, while overall survival and systemic disease-free survival were secondary end points, she said.

Of the 934 patients, 3 were excluded, including 2 patients in whom no tumor was found in the sentinel node and 1 patient who withdrew consent, Dr. Galimberti said. Of the remaining 931 patients in the intent to treat population, 17 of the 464 assigned to axial dissection did not receive it and 14 of the 467 assigned to no dissection did receive it, she said.

At study entry, mean patient age was 54 years, and more than half (56%) of the patients were postmenopausal. Regarding disease characteristics, 67% of the patients had tumors less than 2 cm, 7% had tumors 3 cm or larger, and 26% had grade 3 disease "Most of the tumors [89%] were estrogen receptor–positive and 75% were progesterone receptor–positive," Dr. Galimberti said. In the involved sentinel nodes, 67% of the patients had micrometastasis less than 1.0 mm, 29% had micrometastasis from 1.1-2.0, 2% had metastasis greater than 2.0, and 2% were unknown, she said.

In all, 96% of the patients underwent lymphoscintigraphy and evidence of one or two sentinel nodes was found in 85% of them, Dr. Galimberti reported. Previous excision biopsy was performed in 16% of the patients, and conservative surgery was the definitive treatment in three-quarters of the patients while 25% received mastectomy. Similar rates of adjuvant radiotherapy, hormonal therapy, and chemotherapy were seen in both groups, she said.

Long-term adverse events were more prevalent in the dissection group, with 18% experiencing sensory neuropathy, compared with 12% of those not undergoing dissection. Similarly, the respective rates of lymphedema were 13% and 4% and the respective rates of motor neuropathy were 8% and 3%, Dr. Galimberti reported.

The 5-year disease-free survival rates in the dissection and no dissection groups were 87.3% and 88.4%, respectively, said Dr. Galimberti. The 5-year overall survival rates were similar between both groups as well, at 97.6% in the dissection group and 98% in the no-dissection group.

"In total, there were 17 [3.7%] deaths among the patients who underwent dissection and 12 [2.6%] among those who did not," she said.

The lack of a difference between the groups for the primary end point of disease-free survival fulfilled the protocol-specified criterion for noninferiority. Indeed, Dr. Galimberti noted, "The 5-year disease-free survival of 88% in the patients who did not undergo dissection was much better than the 70% that was anticipated in the original plan," she said. The rate of reappearance of tumor in the undissected axilla was also unexpectedly low, at about 1%, she added.

"It seems likely that the results of the IBCSG Trial 23-01 and Z0011 will change clinical practice, allowing no axillary dissection in early breast cancer, especially when the sentinel node is minimally involved, to reduce [associated] complications with no adverse effect on survival," Dr. Galimberti concluded.

Dr. Galimberti reported having no relevant financial conflicts to disclose.