Breast Cancer

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society

SAN ANTONIO – Long-term upper-extremity pain and functional impairment following breast cancer surgery are reduced by an innovative physical therapy–centered surveillance program, according to a 5-year prospective study.

The program was developed at the breast care center of Walter Reed National Military Medical Center, Bethesda, Md. It begins with a preoperative patient interview and structured evaluation by a physical therapist. The assessment includes what physical therapists call an upper-quarter screen, which evaluates shoulder range of motion, strength, and arm volume. Self-reported pain, fatigue, function, and activity level are recorded.

At that time, the patient is also instructed in a home exercise program she is to start 2 weeks post surgery. These are simple range-of-motion exercises focused on forward flexion overhead; abduction; internal and external rotation of the glenohumeral joint; and scapular retraction, Nicole L. Stout explained at the San Antonio Breast Cancer Symposium.

The patient is subsequently seen by the physical therapist (in conjunction with her regular follow-up visits with an oncologist or surgeon) at 1, 3, 6, 9, 12, and 60 months post surgery. If upper-extremity dysfunction worsens, more intensive interventions are introduced.

The rationale for this prospective surveillance program lies in an understanding that the shoulder and arm impairments caused by breast cancer surgery and radiation therapy are typically subtle initially, but if left unidentified and uncorrected, they often progress to serious rotator cuff damage, "frozen" shoulder, and debilitating lymphedema, according to Ms. Stout, a civilian research physical therapist at the military center.

She had previously presented her 1-year prospective outcomes. This time around, she presented prospective 5-year follow-up data on 86 breast cancer patients who participated in the program. This is the first prospective cohort study in the United States to track breast cancer–related upper-extremity morbidity and functional outcomes for this long a time period.

The 12-month and 5-year visits included formal assessment of upper-extremity outcomes using the Harvard Alumni Activity Survey, the Upper Limb Disability Questionnaire, and the Short Form-36.

At 5 years, 11% of the women had stage I/II lymphedema and 38% had subclinical lymphedema (defined as less than 3% arm volume swelling as measured by a Perometer). These results compare favorably with those of published studies on lymphedema, which have reported long-term rates of stage I-III arm swelling in the 40%-60% range, she noted.

In all, 18% of patients reported arm numbness at 5 years, 17% noted shoulder pain, 3% had neck pain, and 1% had chest wall pain.

One-third of subjects reported fatigue of level 3 or more on a 10-point visual analog scale. Again, other investigators have documented long-term rates of clinically significant fatigue in the 50%-60% range.

At 5 years post surgery, patients demonstrated less impairment of physical activity than at preoperative baseline. At baseline, 33% had significant limitations in terms of carrying heavy objects, performing household chores, and other physical activities. After 5 years of prospective surveillance and tailored physical therapy, only 20% of patients had physical activity limitations.

However, 68% of patients reported experiencing some restrictions on their social activity at 5 years, and 52% experienced limitations on their recreational activities.

The study was funded by the medical center. Ms. Stout declared having no financial conflicts of interest.

SAN ANTONIO – Long-term upper-extremity pain and functional impairment following breast cancer surgery are reduced by an innovative physical therapy–centered surveillance program, according to a 5-year prospective study.

The program was developed at the breast care center of Walter Reed National Military Medical Center, Bethesda, Md. It begins with a preoperative patient interview and structured evaluation by a physical therapist. The assessment includes what physical therapists call an upper-quarter screen, which evaluates shoulder range of motion, strength, and arm volume. Self-reported pain, fatigue, function, and activity level are recorded.

At that time, the patient is also instructed in a home exercise program she is to start 2 weeks post surgery. These are simple range-of-motion exercises focused on forward flexion overhead; abduction; internal and external rotation of the glenohumeral joint; and scapular retraction, Nicole L. Stout explained at the San Antonio Breast Cancer Symposium.

The patient is subsequently seen by the physical therapist (in conjunction with her regular follow-up visits with an oncologist or surgeon) at 1, 3, 6, 9, 12, and 60 months post surgery. If upper-extremity dysfunction worsens, more intensive interventions are introduced.

The rationale for this prospective surveillance program lies in an understanding that the shoulder and arm impairments caused by breast cancer surgery and radiation therapy are typically subtle initially, but if left unidentified and uncorrected, they often progress to serious rotator cuff damage, "frozen" shoulder, and debilitating lymphedema, according to Ms. Stout, a civilian research physical therapist at the military center.

She had previously presented her 1-year prospective outcomes. This time around, she presented prospective 5-year follow-up data on 86 breast cancer patients who participated in the program. This is the first prospective cohort study in the United States to track breast cancer–related upper-extremity morbidity and functional outcomes for this long a time period.

The 12-month and 5-year visits included formal assessment of upper-extremity outcomes using the Harvard Alumni Activity Survey, the Upper Limb Disability Questionnaire, and the Short Form-36.

At 5 years, 11% of the women had stage I/II lymphedema and 38% had subclinical lymphedema (defined as less than 3% arm volume swelling as measured by a Perometer). These results compare favorably with those of published studies on lymphedema, which have reported long-term rates of stage I-III arm swelling in the 40%-60% range, she noted.

In all, 18% of patients reported arm numbness at 5 years, 17% noted shoulder pain, 3% had neck pain, and 1% had chest wall pain.

One-third of subjects reported fatigue of level 3 or more on a 10-point visual analog scale. Again, other investigators have documented long-term rates of clinically significant fatigue in the 50%-60% range.

At 5 years post surgery, patients demonstrated less impairment of physical activity than at preoperative baseline. At baseline, 33% had significant limitations in terms of carrying heavy objects, performing household chores, and other physical activities. After 5 years of prospective surveillance and tailored physical therapy, only 20% of patients had physical activity limitations.

However, 68% of patients reported experiencing some restrictions on their social activity at 5 years, and 52% experienced limitations on their recreational activities.

The study was funded by the medical center. Ms. Stout declared having no financial conflicts of interest.

SAN ANTONIO – Long-term upper-extremity pain and functional impairment following breast cancer surgery are reduced by an innovative physical therapy–centered surveillance program, according to a 5-year prospective study.

The program was developed at the breast care center of Walter Reed National Military Medical Center, Bethesda, Md. It begins with a preoperative patient interview and structured evaluation by a physical therapist. The assessment includes what physical therapists call an upper-quarter screen, which evaluates shoulder range of motion, strength, and arm volume. Self-reported pain, fatigue, function, and activity level are recorded.

At that time, the patient is also instructed in a home exercise program she is to start 2 weeks post surgery. These are simple range-of-motion exercises focused on forward flexion overhead; abduction; internal and external rotation of the glenohumeral joint; and scapular retraction, Nicole L. Stout explained at the San Antonio Breast Cancer Symposium.

The patient is subsequently seen by the physical therapist (in conjunction with her regular follow-up visits with an oncologist or surgeon) at 1, 3, 6, 9, 12, and 60 months post surgery. If upper-extremity dysfunction worsens, more intensive interventions are introduced.

The rationale for this prospective surveillance program lies in an understanding that the shoulder and arm impairments caused by breast cancer surgery and radiation therapy are typically subtle initially, but if left unidentified and uncorrected, they often progress to serious rotator cuff damage, "frozen" shoulder, and debilitating lymphedema, according to Ms. Stout, a civilian research physical therapist at the military center.

She had previously presented her 1-year prospective outcomes. This time around, she presented prospective 5-year follow-up data on 86 breast cancer patients who participated in the program. This is the first prospective cohort study in the United States to track breast cancer–related upper-extremity morbidity and functional outcomes for this long a time period.

The 12-month and 5-year visits included formal assessment of upper-extremity outcomes using the Harvard Alumni Activity Survey, the Upper Limb Disability Questionnaire, and the Short Form-36.

At 5 years, 11% of the women had stage I/II lymphedema and 38% had subclinical lymphedema (defined as less than 3% arm volume swelling as measured by a Perometer). These results compare favorably with those of published studies on lymphedema, which have reported long-term rates of stage I-III arm swelling in the 40%-60% range, she noted.

In all, 18% of patients reported arm numbness at 5 years, 17% noted shoulder pain, 3% had neck pain, and 1% had chest wall pain.

One-third of subjects reported fatigue of level 3 or more on a 10-point visual analog scale. Again, other investigators have documented long-term rates of clinically significant fatigue in the 50%-60% range.

At 5 years post surgery, patients demonstrated less impairment of physical activity than at preoperative baseline. At baseline, 33% had significant limitations in terms of carrying heavy objects, performing household chores, and other physical activities. After 5 years of prospective surveillance and tailored physical therapy, only 20% of patients had physical activity limitations.

However, 68% of patients reported experiencing some restrictions on their social activity at 5 years, and 52% experienced limitations on their recreational activities.

The study was funded by the medical center. Ms. Stout declared having no financial conflicts of interest.

SAN ANTONIO – Adjuvant therapy with ibandronate made no impact on disease-free survival or overall survival rates in women with node-positive, early breast cancer that had been treated with dose-dense chemotherapy in a phase-III study of more than 3,000 patients.

The 3-year disease-free survival rate of 87.6% in those on ibandronate (Boniva) was a close match with the 87.2% that was recorded in a control group under observation. The 3-year overall survival rates also were similar, at 94.7% with ibandronate and 94.1% with observation.

There were no differences in disease-free survival for any of the subgroup analyses, Volker Möbus, Ph.D., reported at the annual San Antonio Breast Cancer Symposium.

"The interim analysis for efficacy showed little difference between treatment arms with and without ibandronate," said Dr. Möbus, head of obstetrics and gynecology at Klinikum Frankfurt (Germany) Höchst. The interim analysis was planned when 50% (405) of the expected events had been reached.

The GAIN (German Adjuvant Intergroup Node-Positive Study) trial is a controlled, nonblinded, randomized, phase III trial. The investigators compared epirubicin, cyclophosphamide, and paclitaxel chemotherapy with epirubicin and cyclophosphamide followed by paclitaxel and capecitabine. In addition, patients were further randomized in a 2:1 ratio to receive ibandronate (50 mg/day for 2 years) or observation alone.

Dr. Möbus presented the results for the ibandronate component of the trial. The chemotherapy results have not been released.

The GAIN trial randomized 3,023 women between June 2004 and August 2008. The protocol required that they be aged from 18 to younger than 65 years, and have histologically confirmed, lymph node–positive uni- or bilateral primary breast cancer, as well as an ECOG performance score of at least 2. Patients could have no distant metastases, and a life expectancy of at least 10 years was required. The median age was 50 years, and median follow-up was 39 months.

In all, 2,015 and 1,008 patients, respectively, were randomized to ibandronate vs. observation. However, 15 patients in the observation arm also started ibandronate, for a total of 1,870 patients. Some 18% of patients on ibandronate discontinued use of the drug for a variety of reasons, including death, adverse events, and loss to follow-up, noted Dr. Möbus.

An oral bisphosphonate, ibandronate is approved for the prevention and treatment of osteoporosis in postmenopausal women in the United States.

Financial support for the study was provided by Amgen and Roche. Dr. Möbus and several of his coinvestigators disclosed financial relationships with Amgen and Roche.

SAN ANTONIO – Adjuvant therapy with ibandronate made no impact on disease-free survival or overall survival rates in women with node-positive, early breast cancer that had been treated with dose-dense chemotherapy in a phase-III study of more than 3,000 patients.

The 3-year disease-free survival rate of 87.6% in those on ibandronate (Boniva) was a close match with the 87.2% that was recorded in a control group under observation. The 3-year overall survival rates also were similar, at 94.7% with ibandronate and 94.1% with observation.

There were no differences in disease-free survival for any of the subgroup analyses, Volker Möbus, Ph.D., reported at the annual San Antonio Breast Cancer Symposium.

"The interim analysis for efficacy showed little difference between treatment arms with and without ibandronate," said Dr. Möbus, head of obstetrics and gynecology at Klinikum Frankfurt (Germany) Höchst. The interim analysis was planned when 50% (405) of the expected events had been reached.

The GAIN (German Adjuvant Intergroup Node-Positive Study) trial is a controlled, nonblinded, randomized, phase III trial. The investigators compared epirubicin, cyclophosphamide, and paclitaxel chemotherapy with epirubicin and cyclophosphamide followed by paclitaxel and capecitabine. In addition, patients were further randomized in a 2:1 ratio to receive ibandronate (50 mg/day for 2 years) or observation alone.

Dr. Möbus presented the results for the ibandronate component of the trial. The chemotherapy results have not been released.

The GAIN trial randomized 3,023 women between June 2004 and August 2008. The protocol required that they be aged from 18 to younger than 65 years, and have histologically confirmed, lymph node–positive uni- or bilateral primary breast cancer, as well as an ECOG performance score of at least 2. Patients could have no distant metastases, and a life expectancy of at least 10 years was required. The median age was 50 years, and median follow-up was 39 months.

In all, 2,015 and 1,008 patients, respectively, were randomized to ibandronate vs. observation. However, 15 patients in the observation arm also started ibandronate, for a total of 1,870 patients. Some 18% of patients on ibandronate discontinued use of the drug for a variety of reasons, including death, adverse events, and loss to follow-up, noted Dr. Möbus.

An oral bisphosphonate, ibandronate is approved for the prevention and treatment of osteoporosis in postmenopausal women in the United States.

Financial support for the study was provided by Amgen and Roche. Dr. Möbus and several of his coinvestigators disclosed financial relationships with Amgen and Roche.

SAN ANTONIO – Adjuvant therapy with ibandronate made no impact on disease-free survival or overall survival rates in women with node-positive, early breast cancer that had been treated with dose-dense chemotherapy in a phase-III study of more than 3,000 patients.

The 3-year disease-free survival rate of 87.6% in those on ibandronate (Boniva) was a close match with the 87.2% that was recorded in a control group under observation. The 3-year overall survival rates also were similar, at 94.7% with ibandronate and 94.1% with observation.

There were no differences in disease-free survival for any of the subgroup analyses, Volker Möbus, Ph.D., reported at the annual San Antonio Breast Cancer Symposium.

"The interim analysis for efficacy showed little difference between treatment arms with and without ibandronate," said Dr. Möbus, head of obstetrics and gynecology at Klinikum Frankfurt (Germany) Höchst. The interim analysis was planned when 50% (405) of the expected events had been reached.

The GAIN (German Adjuvant Intergroup Node-Positive Study) trial is a controlled, nonblinded, randomized, phase III trial. The investigators compared epirubicin, cyclophosphamide, and paclitaxel chemotherapy with epirubicin and cyclophosphamide followed by paclitaxel and capecitabine. In addition, patients were further randomized in a 2:1 ratio to receive ibandronate (50 mg/day for 2 years) or observation alone.

Dr. Möbus presented the results for the ibandronate component of the trial. The chemotherapy results have not been released.

The GAIN trial randomized 3,023 women between June 2004 and August 2008. The protocol required that they be aged from 18 to younger than 65 years, and have histologically confirmed, lymph node–positive uni- or bilateral primary breast cancer, as well as an ECOG performance score of at least 2. Patients could have no distant metastases, and a life expectancy of at least 10 years was required. The median age was 50 years, and median follow-up was 39 months.

In all, 2,015 and 1,008 patients, respectively, were randomized to ibandronate vs. observation. However, 15 patients in the observation arm also started ibandronate, for a total of 1,870 patients. Some 18% of patients on ibandronate discontinued use of the drug for a variety of reasons, including death, adverse events, and loss to follow-up, noted Dr. Möbus.

An oral bisphosphonate, ibandronate is approved for the prevention and treatment of osteoporosis in postmenopausal women in the United States.

Financial support for the study was provided by Amgen and Roche. Dr. Möbus and several of his coinvestigators disclosed financial relationships with Amgen and Roche.

SAN ANTONIO – Curbing colony-stimulating factor use at the start of dose-dense chemotherapy in Medicare patients with hormone receptor–positive breast cancer would save nearly $40 million per year in a population unlikely to gain meaningful benefit from such therapy, according to a new study.

The use of first-cycle colony-stimulating factor (CSF) therapy took off in 2002, Dr. Dawn L. Hershman told attendees at the San Antonio Breast Cancer Symposium. That was the year the benefits of dose-dense chemotherapy were reported, and pegfilgrastim (Neulasta), a granulocyte CSF that was easier to use than those previously available, received marketing approval from the Food and Drug Administration.

A new analysis of Medicare data shows that first-cycle use of CSFs in patients with stage I-III breast cancer jumped from 13% during 1998-2002 to 68% in 2002-2005, reported Dr. Hershman of Columbia University, New York.

In the last half-decade, however, multiple major studies have convincingly shown that the benefits of dose-dense chemotherapy with first-cycle CSFs are confined to breast cancer patients with hormone receptor–negative tumors, according to Dr. Hershman.

For example, one meta-analysis of studies comparing dose-dense to standard chemotherapy in 3,337 estrogen receptor–negative patients showed that dose-dense chemotherapy yielded a 29% reduction in recurrence risk and a 16% improvement in overall survival. In 1,344 estrogen receptor–positive patients, in contrast, dose-dense chemotherapy provided a nonsignificant 8% reduction in recurrence risk and no hint of a benefit in terms of overall survival (J. Natl. Cancer Inst. 2010;102:1845-54).

For the new study, Dr. Hershman and her coauthors identified 10,773 patients in a combined Surveillance, Epidemiology, and End Results (SEER)-Medicare database who were over age 65 with stage I-III breast cancer diagnosed during 1998-2005, and who had at least one chemotherapy claim within 6 months of diagnosis. Of these, 5,266 had a CSF claim during therapy. First-cycle CSF use increased from 13% to 68% over the study period, and the use of pegfilgrastim jumped from 4% to 84%.

"We’re very quick in oncology to adopt, and we never pull back – even when there’s evidence against," Dr. Hershman said. "If we have to make decisions in terms of controlling costs, we shouldn’t be giving drugs that are costly and have no benefit."

Dr. Thomas J. Smith, chair of the session at which Dr. Hershman presented the new study, took the argument further, citing Dr. Hershman’s own earlier study suggesting that CSF therapy in elderly women may actually cause significant harm. In an analysis in which she merged Medicare and SEER databases, Dr. Hershman had reported a twofold increased risk of acute myeloid leukemia and myelodysplastic syndrome in elderly women who received a CSF compared with those who did not (J. Natl. Cancer Inst. 2007;99:196-205).

"All that nearly $40 million per year in Medicare expenditures for colony-stimulating factors is buying is toxicity. You’re not buying any disease benefit," argued Dr. Smith, director of palliative care and Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore.

He proposed that it’s time to consider putting the use of CSFs and dose-dense chemotherapy in elderly patients with hormone receptor–positive tumors on the Quality Oncology Practice Initiative's "do not use" list.

"My thought would be at a minimum we should explain the very small, at-most 8% relative benefit, and the risks. And most people, I think, given the numbers, would say, ‘I’ll take regular chemotherapy, thank you,’ " Dr. Smith predicted.

Dr. Hershman declared having no financial conflicts.

SAN ANTONIO – Curbing colony-stimulating factor use at the start of dose-dense chemotherapy in Medicare patients with hormone receptor–positive breast cancer would save nearly $40 million per year in a population unlikely to gain meaningful benefit from such therapy, according to a new study.

The use of first-cycle colony-stimulating factor (CSF) therapy took off in 2002, Dr. Dawn L. Hershman told attendees at the San Antonio Breast Cancer Symposium. That was the year the benefits of dose-dense chemotherapy were reported, and pegfilgrastim (Neulasta), a granulocyte CSF that was easier to use than those previously available, received marketing approval from the Food and Drug Administration.

A new analysis of Medicare data shows that first-cycle use of CSFs in patients with stage I-III breast cancer jumped from 13% during 1998-2002 to 68% in 2002-2005, reported Dr. Hershman of Columbia University, New York.

In the last half-decade, however, multiple major studies have convincingly shown that the benefits of dose-dense chemotherapy with first-cycle CSFs are confined to breast cancer patients with hormone receptor–negative tumors, according to Dr. Hershman.

For example, one meta-analysis of studies comparing dose-dense to standard chemotherapy in 3,337 estrogen receptor–negative patients showed that dose-dense chemotherapy yielded a 29% reduction in recurrence risk and a 16% improvement in overall survival. In 1,344 estrogen receptor–positive patients, in contrast, dose-dense chemotherapy provided a nonsignificant 8% reduction in recurrence risk and no hint of a benefit in terms of overall survival (J. Natl. Cancer Inst. 2010;102:1845-54).

For the new study, Dr. Hershman and her coauthors identified 10,773 patients in a combined Surveillance, Epidemiology, and End Results (SEER)-Medicare database who were over age 65 with stage I-III breast cancer diagnosed during 1998-2005, and who had at least one chemotherapy claim within 6 months of diagnosis. Of these, 5,266 had a CSF claim during therapy. First-cycle CSF use increased from 13% to 68% over the study period, and the use of pegfilgrastim jumped from 4% to 84%.

"We’re very quick in oncology to adopt, and we never pull back – even when there’s evidence against," Dr. Hershman said. "If we have to make decisions in terms of controlling costs, we shouldn’t be giving drugs that are costly and have no benefit."

Dr. Thomas J. Smith, chair of the session at which Dr. Hershman presented the new study, took the argument further, citing Dr. Hershman’s own earlier study suggesting that CSF therapy in elderly women may actually cause significant harm. In an analysis in which she merged Medicare and SEER databases, Dr. Hershman had reported a twofold increased risk of acute myeloid leukemia and myelodysplastic syndrome in elderly women who received a CSF compared with those who did not (J. Natl. Cancer Inst. 2007;99:196-205).

"All that nearly $40 million per year in Medicare expenditures for colony-stimulating factors is buying is toxicity. You’re not buying any disease benefit," argued Dr. Smith, director of palliative care and Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore.

He proposed that it’s time to consider putting the use of CSFs and dose-dense chemotherapy in elderly patients with hormone receptor–positive tumors on the Quality Oncology Practice Initiative's "do not use" list.

"My thought would be at a minimum we should explain the very small, at-most 8% relative benefit, and the risks. And most people, I think, given the numbers, would say, ‘I’ll take regular chemotherapy, thank you,’ " Dr. Smith predicted.

Dr. Hershman declared having no financial conflicts.

SAN ANTONIO – Curbing colony-stimulating factor use at the start of dose-dense chemotherapy in Medicare patients with hormone receptor–positive breast cancer would save nearly $40 million per year in a population unlikely to gain meaningful benefit from such therapy, according to a new study.

The use of first-cycle colony-stimulating factor (CSF) therapy took off in 2002, Dr. Dawn L. Hershman told attendees at the San Antonio Breast Cancer Symposium. That was the year the benefits of dose-dense chemotherapy were reported, and pegfilgrastim (Neulasta), a granulocyte CSF that was easier to use than those previously available, received marketing approval from the Food and Drug Administration.

A new analysis of Medicare data shows that first-cycle use of CSFs in patients with stage I-III breast cancer jumped from 13% during 1998-2002 to 68% in 2002-2005, reported Dr. Hershman of Columbia University, New York.

In the last half-decade, however, multiple major studies have convincingly shown that the benefits of dose-dense chemotherapy with first-cycle CSFs are confined to breast cancer patients with hormone receptor–negative tumors, according to Dr. Hershman.

For example, one meta-analysis of studies comparing dose-dense to standard chemotherapy in 3,337 estrogen receptor–negative patients showed that dose-dense chemotherapy yielded a 29% reduction in recurrence risk and a 16% improvement in overall survival. In 1,344 estrogen receptor–positive patients, in contrast, dose-dense chemotherapy provided a nonsignificant 8% reduction in recurrence risk and no hint of a benefit in terms of overall survival (J. Natl. Cancer Inst. 2010;102:1845-54).

For the new study, Dr. Hershman and her coauthors identified 10,773 patients in a combined Surveillance, Epidemiology, and End Results (SEER)-Medicare database who were over age 65 with stage I-III breast cancer diagnosed during 1998-2005, and who had at least one chemotherapy claim within 6 months of diagnosis. Of these, 5,266 had a CSF claim during therapy. First-cycle CSF use increased from 13% to 68% over the study period, and the use of pegfilgrastim jumped from 4% to 84%.

"We’re very quick in oncology to adopt, and we never pull back – even when there’s evidence against," Dr. Hershman said. "If we have to make decisions in terms of controlling costs, we shouldn’t be giving drugs that are costly and have no benefit."

Dr. Thomas J. Smith, chair of the session at which Dr. Hershman presented the new study, took the argument further, citing Dr. Hershman’s own earlier study suggesting that CSF therapy in elderly women may actually cause significant harm. In an analysis in which she merged Medicare and SEER databases, Dr. Hershman had reported a twofold increased risk of acute myeloid leukemia and myelodysplastic syndrome in elderly women who received a CSF compared with those who did not (J. Natl. Cancer Inst. 2007;99:196-205).

"All that nearly $40 million per year in Medicare expenditures for colony-stimulating factors is buying is toxicity. You’re not buying any disease benefit," argued Dr. Smith, director of palliative care and Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore.

He proposed that it’s time to consider putting the use of CSFs and dose-dense chemotherapy in elderly patients with hormone receptor–positive tumors on the Quality Oncology Practice Initiative's "do not use" list.

"My thought would be at a minimum we should explain the very small, at-most 8% relative benefit, and the risks. And most people, I think, given the numbers, would say, ‘I’ll take regular chemotherapy, thank you,’ " Dr. Smith predicted.

Dr. Hershman declared having no financial conflicts.

ORLANDO – Beta-blockers appear to be cardioprotective in breast cancer patients on trastuzumab, according to a prospective case-control study.

The risk of developing new-onset heart failure or left ventricular dysfunction during 1 year on trastuzumab (Herceptin) was 65% lower in 30 breast cancer patients who were incidentally on a beta-blocker at the start of the monoclonal antibody therapy than in 167 other breast cancer patients who were not, Thomas B. Cook, Ph.D., reported at the annual scientific sessions of the American Heart Association.

The women on a beta-blocker averaged 59 years of age, a full 8 years older than the breast cancer patients not on a beta-blocker. The patients on a beta-blocker also had significantly higher rates of hypertension, diabetes, obesity, and smoking. After adjustment for these traditional cardiovascular risk factors as well as other factors predisposing to heart failure, including prior treatment with anthracyclines or radiation therapy, the beta-blocker group had an adjusted 83% lower risk of developing cardiotoxicity during 1 year of follow-up on trastuzumab (P = .006).

This is a small hypothesis-generating study. The findings warrant a proper randomized controlled trial assessing the impact of prophylactic beta-blocker therapy in breast cancer patients going on trastuzumab, Dr. Cook asserted.

In all, 22 of the 197 breast cancer patients were on an ACE inhibitor at the time they started on trastuzumab. Logistic regression analysis indicated no cardioprotective effect for this class of medication, according to Dr. Cook of the Cleveland Clinic Foundation.

New-onset heart failure was diagnosed in 11% of patients not on a beta-blocker and in none who were. Left ventricular dysfunction – defined as an echocardiographically documented ejection fraction decline of at least 10% – occurred in 40% of trastuzumab users not on a beta-blocker, compared to 20% who were.

A trajectory analysis of serial echocardiographic exams revealed overall significant declines in left ventricular ejection fraction in patients during their year of follow-up on trastuzumab; however, the decline was markedly steeper in those who were not on a beta-blocker.

Interestingly, neither prior treatment with anthracyclines, even in excess of four cycles, nor other prior chemotherapy were predictive of cardiotoxicity in this series of trastuzumab-treated women. Current smoking, however, was associated with a 4.2-fold increased risk.

Dr. Cook reported no financial conflicts.

ORLANDO – Beta-blockers appear to be cardioprotective in breast cancer patients on trastuzumab, according to a prospective case-control study.

The risk of developing new-onset heart failure or left ventricular dysfunction during 1 year on trastuzumab (Herceptin) was 65% lower in 30 breast cancer patients who were incidentally on a beta-blocker at the start of the monoclonal antibody therapy than in 167 other breast cancer patients who were not, Thomas B. Cook, Ph.D., reported at the annual scientific sessions of the American Heart Association.

The women on a beta-blocker averaged 59 years of age, a full 8 years older than the breast cancer patients not on a beta-blocker. The patients on a beta-blocker also had significantly higher rates of hypertension, diabetes, obesity, and smoking. After adjustment for these traditional cardiovascular risk factors as well as other factors predisposing to heart failure, including prior treatment with anthracyclines or radiation therapy, the beta-blocker group had an adjusted 83% lower risk of developing cardiotoxicity during 1 year of follow-up on trastuzumab (P = .006).

This is a small hypothesis-generating study. The findings warrant a proper randomized controlled trial assessing the impact of prophylactic beta-blocker therapy in breast cancer patients going on trastuzumab, Dr. Cook asserted.

In all, 22 of the 197 breast cancer patients were on an ACE inhibitor at the time they started on trastuzumab. Logistic regression analysis indicated no cardioprotective effect for this class of medication, according to Dr. Cook of the Cleveland Clinic Foundation.

New-onset heart failure was diagnosed in 11% of patients not on a beta-blocker and in none who were. Left ventricular dysfunction – defined as an echocardiographically documented ejection fraction decline of at least 10% – occurred in 40% of trastuzumab users not on a beta-blocker, compared to 20% who were.

A trajectory analysis of serial echocardiographic exams revealed overall significant declines in left ventricular ejection fraction in patients during their year of follow-up on trastuzumab; however, the decline was markedly steeper in those who were not on a beta-blocker.

Interestingly, neither prior treatment with anthracyclines, even in excess of four cycles, nor other prior chemotherapy were predictive of cardiotoxicity in this series of trastuzumab-treated women. Current smoking, however, was associated with a 4.2-fold increased risk.

Dr. Cook reported no financial conflicts.

ORLANDO – Beta-blockers appear to be cardioprotective in breast cancer patients on trastuzumab, according to a prospective case-control study.

The risk of developing new-onset heart failure or left ventricular dysfunction during 1 year on trastuzumab (Herceptin) was 65% lower in 30 breast cancer patients who were incidentally on a beta-blocker at the start of the monoclonal antibody therapy than in 167 other breast cancer patients who were not, Thomas B. Cook, Ph.D., reported at the annual scientific sessions of the American Heart Association.

The women on a beta-blocker averaged 59 years of age, a full 8 years older than the breast cancer patients not on a beta-blocker. The patients on a beta-blocker also had significantly higher rates of hypertension, diabetes, obesity, and smoking. After adjustment for these traditional cardiovascular risk factors as well as other factors predisposing to heart failure, including prior treatment with anthracyclines or radiation therapy, the beta-blocker group had an adjusted 83% lower risk of developing cardiotoxicity during 1 year of follow-up on trastuzumab (P = .006).

This is a small hypothesis-generating study. The findings warrant a proper randomized controlled trial assessing the impact of prophylactic beta-blocker therapy in breast cancer patients going on trastuzumab, Dr. Cook asserted.

In all, 22 of the 197 breast cancer patients were on an ACE inhibitor at the time they started on trastuzumab. Logistic regression analysis indicated no cardioprotective effect for this class of medication, according to Dr. Cook of the Cleveland Clinic Foundation.

New-onset heart failure was diagnosed in 11% of patients not on a beta-blocker and in none who were. Left ventricular dysfunction – defined as an echocardiographically documented ejection fraction decline of at least 10% – occurred in 40% of trastuzumab users not on a beta-blocker, compared to 20% who were.

A trajectory analysis of serial echocardiographic exams revealed overall significant declines in left ventricular ejection fraction in patients during their year of follow-up on trastuzumab; however, the decline was markedly steeper in those who were not on a beta-blocker.

Interestingly, neither prior treatment with anthracyclines, even in excess of four cycles, nor other prior chemotherapy were predictive of cardiotoxicity in this series of trastuzumab-treated women. Current smoking, however, was associated with a 4.2-fold increased risk.

Dr. Cook reported no financial conflicts.