SABCS 2014

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

SAN ANTONIO – Breast cancer mortality in American women under age 50 declined markedly among whites during a recent two-decade period, less so in blacks.

“The racial gaps in survival have not closed. Young black women continue to have a worse outcome than young whites,” Dr. Foluso O. Ademuyiwa said at the San Antonio Breast Cancer Symposium.

She presented an analysis of Surveillance, Epidemiology, and End Results (SEER) registry data that included 162,976 women diagnosed with invasive breast cancer at age 18-49 during 1990-2009. Whites accounted for 77.7% of the total, blacks 12.5%, and other races 9.8%.

Twenty percent of patients had died by the median followup of 85 months. Five- and 10-year overall survival rates were 87.9% and 79.5%, respectively, among white patients, 74.9% and 64.3% for blacks, and 88.5% and 80.7% for women of other races, reported Dr. Ademuyiwa of Washington University, St. Louis.

During all 5-year sections of the study period, the highest risk of breast cancer mortality was in the first 3 years following diagnosis. However, annual risk of mortality in the first 3 years declined for white women from 3.4% during 1990-1994 to 1.9% during 2005-2009, and from 6.4% during 1990-1994 to 4.5% during 2005-2009 for black women.

Young black breast cancer patients had a more aggressive tumor biology. Thirty-seven percent of them had estrogen receptor–negative tumors, compared with 24% of white patients. Their disease was also at a higher stage and grade at diagnosis. Moreover, their tumors were larger in size; only 34.5% of black patients’ tumors were less than 2 cm in size, compared with 47.3% for white patients and 45.3% for women of other races.

A greater proportion of the invasive breast cancer cases in young women were diagnosed in more recent years. Roughly 13% of all cases in the SEER registry for 1990-2009 were diagnosed in 1990-1994, 16% in 1995-1999, 35% in 2000-2004, and 36% during 2005-2009. The explanation for this trend may be more widespread use of screening, changes in the reproductive risk profile over time, or some combination of the two factors, according to Dr. Ademuyiwa.

She reported having no financial conflicts with regard to this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Breast cancer mortality in American women under age 50 declined markedly among whites during a recent two-decade period, less so in blacks.

“The racial gaps in survival have not closed. Young black women continue to have a worse outcome than young whites,” Dr. Foluso O. Ademuyiwa said at the San Antonio Breast Cancer Symposium.

She presented an analysis of Surveillance, Epidemiology, and End Results (SEER) registry data that included 162,976 women diagnosed with invasive breast cancer at age 18-49 during 1990-2009. Whites accounted for 77.7% of the total, blacks 12.5%, and other races 9.8%.

Twenty percent of patients had died by the median followup of 85 months. Five- and 10-year overall survival rates were 87.9% and 79.5%, respectively, among white patients, 74.9% and 64.3% for blacks, and 88.5% and 80.7% for women of other races, reported Dr. Ademuyiwa of Washington University, St. Louis.

During all 5-year sections of the study period, the highest risk of breast cancer mortality was in the first 3 years following diagnosis. However, annual risk of mortality in the first 3 years declined for white women from 3.4% during 1990-1994 to 1.9% during 2005-2009, and from 6.4% during 1990-1994 to 4.5% during 2005-2009 for black women.

Young black breast cancer patients had a more aggressive tumor biology. Thirty-seven percent of them had estrogen receptor–negative tumors, compared with 24% of white patients. Their disease was also at a higher stage and grade at diagnosis. Moreover, their tumors were larger in size; only 34.5% of black patients’ tumors were less than 2 cm in size, compared with 47.3% for white patients and 45.3% for women of other races.

A greater proportion of the invasive breast cancer cases in young women were diagnosed in more recent years. Roughly 13% of all cases in the SEER registry for 1990-2009 were diagnosed in 1990-1994, 16% in 1995-1999, 35% in 2000-2004, and 36% during 2005-2009. The explanation for this trend may be more widespread use of screening, changes in the reproductive risk profile over time, or some combination of the two factors, according to Dr. Ademuyiwa.

She reported having no financial conflicts with regard to this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Breast cancer mortality in American women under age 50 declined markedly among whites during a recent two-decade period, less so in blacks.

“The racial gaps in survival have not closed. Young black women continue to have a worse outcome than young whites,” Dr. Foluso O. Ademuyiwa said at the San Antonio Breast Cancer Symposium.

She presented an analysis of Surveillance, Epidemiology, and End Results (SEER) registry data that included 162,976 women diagnosed with invasive breast cancer at age 18-49 during 1990-2009. Whites accounted for 77.7% of the total, blacks 12.5%, and other races 9.8%.

Twenty percent of patients had died by the median followup of 85 months. Five- and 10-year overall survival rates were 87.9% and 79.5%, respectively, among white patients, 74.9% and 64.3% for blacks, and 88.5% and 80.7% for women of other races, reported Dr. Ademuyiwa of Washington University, St. Louis.

During all 5-year sections of the study period, the highest risk of breast cancer mortality was in the first 3 years following diagnosis. However, annual risk of mortality in the first 3 years declined for white women from 3.4% during 1990-1994 to 1.9% during 2005-2009, and from 6.4% during 1990-1994 to 4.5% during 2005-2009 for black women.

Young black breast cancer patients had a more aggressive tumor biology. Thirty-seven percent of them had estrogen receptor–negative tumors, compared with 24% of white patients. Their disease was also at a higher stage and grade at diagnosis. Moreover, their tumors were larger in size; only 34.5% of black patients’ tumors were less than 2 cm in size, compared with 47.3% for white patients and 45.3% for women of other races.

A greater proportion of the invasive breast cancer cases in young women were diagnosed in more recent years. Roughly 13% of all cases in the SEER registry for 1990-2009 were diagnosed in 1990-1994, 16% in 1995-1999, 35% in 2000-2004, and 36% during 2005-2009. The explanation for this trend may be more widespread use of screening, changes in the reproductive risk profile over time, or some combination of the two factors, according to Dr. Ademuyiwa.

She reported having no financial conflicts with regard to this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Male breast cancers share some important characteristics with female breast cancers: The tumors found in males are usually hormone receptor positive and of luminal A subtype, and respond less favorably if estrogen and progesterone receptor negative.

And like female breast cancers, both overall and breast cancer–specific survival rates have been increasing over the last 20 years, although not to the extent of survival improvements in women, Dr. Fatima Cardoso said at the San Antonio Breast Cancer Symposium.

Michele G. Sullivan/Frontline Medical News

Dr. Cardoso of the European School of Oncology Breast Cancer Program, Lisbon, presented the initial findings of the Male Breast Cancer International Program, a project intended to identify, characterize, and improve treatment for male breast cancers. The retrospective joint analysis is the first part of the three-step study, she said. In addition to identifying patients in the 10 countries involved (in the United States, western Europe, and Scandinavia), step one includes a collection of tumor blocks for central analysis in labs in the United States and the Netherlands.

Step two, already underway, is building a prospective international registry of all male breast cancer cases in the most recent 30 months of the study, including collection of tumor samples and blood, and a quality of life substudy.

Step three will comprise randomized treatment trials, one of which is “far along in the planning stage,” Dr. Cardoso said.

The retrospective cohort comprised 1,822 men who were diagnosed and treated for breast cancer from 1990 to 2010, with tumor assessments available for 1,483. About two-thirds of the men were older than 50 years; 25% were 75 or older. Just 2% were younger than 40 years.

Most cancers (71%) were local. Almost 60% were node negative, and 30% positive for one node. Two nodes were involved in 5% and the rest had three involved.

Breast-conserving surgery was the most common primary treatment (96%), with 4% undergoing a modified radical mastectomy. Three-fourths underwent both a sentinel node biopsy and axillary dissection; 18% had a sentinel node biopsy only, and the rest had no nodal investigation. There was a slight trend over the study period for more sentinel node biopsies alone, and less axillary dissection, but the number of men without an investigation stayed steady.

After breast-conserving surgery, all of the node-positive patients had adjuvant radiotherapy, as did 46% of the node-negative patients. Of the node-positive patients who had mastectomy, 69% received radiotherapy and 31% did not.

Adjuvant chemotherapy was administered to 70% of patients overall, with anthracyclines the most commonly used agent (43%). Others were the combination of anthracyclines and taxanes (32%); the combination of cyclophosphamide, methotrexate and fluorouracil (15%); and other unspecified regimens in the remainder.

Most men also received endocrine therapy (77%), with tamoxifen being the most common agent (88%).

Invasive ductal carcinoma was by far the most common diagnosis (about 85%). About half the tumors were grade 2; the rest were evenly split between grades 1 and 3.

The vast majority (1,053) were estrogen receptor positive with 93% having high expression. Progesterone receptor positivity occurred in 939 tumors, with 35% having high expression.

Most of the tumors were positive for androgen expression (1,027), again with high expression (88%). Two percent were human epidermal growth factor 2 (HER2) positive.

Not surprisingly, median overall survival was best in patients with nonmetastatic, nonnodal cancers (10.4 years). It was about 8.4 years for those with nonmetastatic, node-positive tumors, and 2.6 years for those with metastatic cancers.

Median overall mortality has significantly decreased over the years: About 70% of those diagnosed from 1990 to 1995 had died within 9 years, compared to about 40% of those diagnosed from 2006 to 2010. But breast cancer–specific mortality remained about the same, with less than 20% of patients dying by the end of follow-up.

Those with estrogen receptor–positive tumors did best, especially if they had high expression, while all of those with ER-negative tumors had died by 6 years after diagnosis. Findings were similar among those with androgen and progesterone receptor–negative tumors.

“Hormone receptor status had a very good prognostic value, with positive, highly expressed tumors having much better outcomes,” Dr. Cardoso said, adding that tumors in this initial phase of the study are still being examined.

She had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – Male breast cancers share some important characteristics with female breast cancers: The tumors found in males are usually hormone receptor positive and of luminal A subtype, and respond less favorably if estrogen and progesterone receptor negative.

And like female breast cancers, both overall and breast cancer–specific survival rates have been increasing over the last 20 years, although not to the extent of survival improvements in women, Dr. Fatima Cardoso said at the San Antonio Breast Cancer Symposium.

Michele G. Sullivan/Frontline Medical News

Dr. Cardoso of the European School of Oncology Breast Cancer Program, Lisbon, presented the initial findings of the Male Breast Cancer International Program, a project intended to identify, characterize, and improve treatment for male breast cancers. The retrospective joint analysis is the first part of the three-step study, she said. In addition to identifying patients in the 10 countries involved (in the United States, western Europe, and Scandinavia), step one includes a collection of tumor blocks for central analysis in labs in the United States and the Netherlands.

Step two, already underway, is building a prospective international registry of all male breast cancer cases in the most recent 30 months of the study, including collection of tumor samples and blood, and a quality of life substudy.

Step three will comprise randomized treatment trials, one of which is “far along in the planning stage,” Dr. Cardoso said.

The retrospective cohort comprised 1,822 men who were diagnosed and treated for breast cancer from 1990 to 2010, with tumor assessments available for 1,483. About two-thirds of the men were older than 50 years; 25% were 75 or older. Just 2% were younger than 40 years.

Most cancers (71%) were local. Almost 60% were node negative, and 30% positive for one node. Two nodes were involved in 5% and the rest had three involved.

Breast-conserving surgery was the most common primary treatment (96%), with 4% undergoing a modified radical mastectomy. Three-fourths underwent both a sentinel node biopsy and axillary dissection; 18% had a sentinel node biopsy only, and the rest had no nodal investigation. There was a slight trend over the study period for more sentinel node biopsies alone, and less axillary dissection, but the number of men without an investigation stayed steady.

After breast-conserving surgery, all of the node-positive patients had adjuvant radiotherapy, as did 46% of the node-negative patients. Of the node-positive patients who had mastectomy, 69% received radiotherapy and 31% did not.

Adjuvant chemotherapy was administered to 70% of patients overall, with anthracyclines the most commonly used agent (43%). Others were the combination of anthracyclines and taxanes (32%); the combination of cyclophosphamide, methotrexate and fluorouracil (15%); and other unspecified regimens in the remainder.

Most men also received endocrine therapy (77%), with tamoxifen being the most common agent (88%).

Invasive ductal carcinoma was by far the most common diagnosis (about 85%). About half the tumors were grade 2; the rest were evenly split between grades 1 and 3.

The vast majority (1,053) were estrogen receptor positive with 93% having high expression. Progesterone receptor positivity occurred in 939 tumors, with 35% having high expression.

Most of the tumors were positive for androgen expression (1,027), again with high expression (88%). Two percent were human epidermal growth factor 2 (HER2) positive.

Not surprisingly, median overall survival was best in patients with nonmetastatic, nonnodal cancers (10.4 years). It was about 8.4 years for those with nonmetastatic, node-positive tumors, and 2.6 years for those with metastatic cancers.

Median overall mortality has significantly decreased over the years: About 70% of those diagnosed from 1990 to 1995 had died within 9 years, compared to about 40% of those diagnosed from 2006 to 2010. But breast cancer–specific mortality remained about the same, with less than 20% of patients dying by the end of follow-up.

Those with estrogen receptor–positive tumors did best, especially if they had high expression, while all of those with ER-negative tumors had died by 6 years after diagnosis. Findings were similar among those with androgen and progesterone receptor–negative tumors.

“Hormone receptor status had a very good prognostic value, with positive, highly expressed tumors having much better outcomes,” Dr. Cardoso said, adding that tumors in this initial phase of the study are still being examined.

She had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – Male breast cancers share some important characteristics with female breast cancers: The tumors found in males are usually hormone receptor positive and of luminal A subtype, and respond less favorably if estrogen and progesterone receptor negative.

And like female breast cancers, both overall and breast cancer–specific survival rates have been increasing over the last 20 years, although not to the extent of survival improvements in women, Dr. Fatima Cardoso said at the San Antonio Breast Cancer Symposium.

Michele G. Sullivan/Frontline Medical News

Dr. Cardoso of the European School of Oncology Breast Cancer Program, Lisbon, presented the initial findings of the Male Breast Cancer International Program, a project intended to identify, characterize, and improve treatment for male breast cancers. The retrospective joint analysis is the first part of the three-step study, she said. In addition to identifying patients in the 10 countries involved (in the United States, western Europe, and Scandinavia), step one includes a collection of tumor blocks for central analysis in labs in the United States and the Netherlands.

Step two, already underway, is building a prospective international registry of all male breast cancer cases in the most recent 30 months of the study, including collection of tumor samples and blood, and a quality of life substudy.

Step three will comprise randomized treatment trials, one of which is “far along in the planning stage,” Dr. Cardoso said.

The retrospective cohort comprised 1,822 men who were diagnosed and treated for breast cancer from 1990 to 2010, with tumor assessments available for 1,483. About two-thirds of the men were older than 50 years; 25% were 75 or older. Just 2% were younger than 40 years.

Most cancers (71%) were local. Almost 60% were node negative, and 30% positive for one node. Two nodes were involved in 5% and the rest had three involved.

Breast-conserving surgery was the most common primary treatment (96%), with 4% undergoing a modified radical mastectomy. Three-fourths underwent both a sentinel node biopsy and axillary dissection; 18% had a sentinel node biopsy only, and the rest had no nodal investigation. There was a slight trend over the study period for more sentinel node biopsies alone, and less axillary dissection, but the number of men without an investigation stayed steady.

After breast-conserving surgery, all of the node-positive patients had adjuvant radiotherapy, as did 46% of the node-negative patients. Of the node-positive patients who had mastectomy, 69% received radiotherapy and 31% did not.

Adjuvant chemotherapy was administered to 70% of patients overall, with anthracyclines the most commonly used agent (43%). Others were the combination of anthracyclines and taxanes (32%); the combination of cyclophosphamide, methotrexate and fluorouracil (15%); and other unspecified regimens in the remainder.

Most men also received endocrine therapy (77%), with tamoxifen being the most common agent (88%).

Invasive ductal carcinoma was by far the most common diagnosis (about 85%). About half the tumors were grade 2; the rest were evenly split between grades 1 and 3.

The vast majority (1,053) were estrogen receptor positive with 93% having high expression. Progesterone receptor positivity occurred in 939 tumors, with 35% having high expression.

Most of the tumors were positive for androgen expression (1,027), again with high expression (88%). Two percent were human epidermal growth factor 2 (HER2) positive.

Not surprisingly, median overall survival was best in patients with nonmetastatic, nonnodal cancers (10.4 years). It was about 8.4 years for those with nonmetastatic, node-positive tumors, and 2.6 years for those with metastatic cancers.

Median overall mortality has significantly decreased over the years: About 70% of those diagnosed from 1990 to 1995 had died within 9 years, compared to about 40% of those diagnosed from 2006 to 2010. But breast cancer–specific mortality remained about the same, with less than 20% of patients dying by the end of follow-up.

Those with estrogen receptor–positive tumors did best, especially if they had high expression, while all of those with ER-negative tumors had died by 6 years after diagnosis. Findings were similar among those with androgen and progesterone receptor–negative tumors.

“Hormone receptor status had a very good prognostic value, with positive, highly expressed tumors having much better outcomes,” Dr. Cardoso said, adding that tumors in this initial phase of the study are still being examined.

She had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – An accelerated course of partial breast irradiation was as effective as whole breast irradiation for women with early breast cancer, with significantly fewer adverse events.

The technique may be a suitable alternative for select patients who wish to minimize side effects without compromising clinical outcomes, Dr. Lorenzo Livi said at the San Antonio Breast Cancer Symposium.

He reported the 5-year results of an Italian study that randomized women with early breast cancer to one of two radiation regimens: conventional (tangential field) fractionated whole breast treatment or accelerated partial breast irradiation plus intensity-modulated radiotherapy.

Michele G. Sullivan/Frontline Medical News

The patients were highly selected, with a primary tumor size of less than 25 mm and negative surgical margins of more than 5 mm, said Dr. Livi, a radiation oncologist at the University of Florence, Italy.

The cohort comprised 520 women. Most (about 85%) were node-negative; 95% of the tumors were estrogen receptor–positive, and 90% were progesterone receptor–positive. The most frequent molecular subtype was luminal A (about 75%); less than 5% were triple-negative.

The median follow-up for this portion of the study was 5 years. There were six ipsilateral breast tumor recurrences – three in each group. There were three local relapses, all in the whole breast irradiation group. The 5-year recurrence rate was 1.4% in the whole breast irradiation group and 1.5% in the partial breast irradiation group. The mean time to ipsilateral breast recurrence was 3 years, and there was no significant between-group difference in this timing.

There were 10 contralateral recurrences (seven in the whole breast group vs. three in the partial irradiation group). Distant metastases occurred in seven patients (four and three, respectively).

The 5-year overall survival rate was excellent, Dr. Livi noted: 97% in the whole breast irradiation group and 99% in the partial irradiation group.

Skin toxicity of any grade was significantly less common in the partial group (49 vs. 181). Significantly more patients in the partial irradiation group were completely free of adverse events (197 vs. 93). There were no grade 3 adverse events in either group. Two women in the whole breast irradiation group experienced a grade 2 toxicity- both of these were skin fibrosis.

Almost all patients (90%) reported good or excellent cosmetic results.

Dr. Livi fielded a few questions during the discussion period, one of which dealt with the cost of partial irradiation treatment. Since the procedure is more expensive, and the results similar, the discussant wondered whether it would be worth the additional cost. Dr Livi said the question is difficult for him to answer, because Italy’s national health care system does not charge patients for the treatment. He did say reimbursement for the treatments differs, but he did not elaborate.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – An accelerated course of partial breast irradiation was as effective as whole breast irradiation for women with early breast cancer, with significantly fewer adverse events.

The technique may be a suitable alternative for select patients who wish to minimize side effects without compromising clinical outcomes, Dr. Lorenzo Livi said at the San Antonio Breast Cancer Symposium.

He reported the 5-year results of an Italian study that randomized women with early breast cancer to one of two radiation regimens: conventional (tangential field) fractionated whole breast treatment or accelerated partial breast irradiation plus intensity-modulated radiotherapy.

Michele G. Sullivan/Frontline Medical News

The patients were highly selected, with a primary tumor size of less than 25 mm and negative surgical margins of more than 5 mm, said Dr. Livi, a radiation oncologist at the University of Florence, Italy.

The cohort comprised 520 women. Most (about 85%) were node-negative; 95% of the tumors were estrogen receptor–positive, and 90% were progesterone receptor–positive. The most frequent molecular subtype was luminal A (about 75%); less than 5% were triple-negative.

The median follow-up for this portion of the study was 5 years. There were six ipsilateral breast tumor recurrences – three in each group. There were three local relapses, all in the whole breast irradiation group. The 5-year recurrence rate was 1.4% in the whole breast irradiation group and 1.5% in the partial breast irradiation group. The mean time to ipsilateral breast recurrence was 3 years, and there was no significant between-group difference in this timing.

There were 10 contralateral recurrences (seven in the whole breast group vs. three in the partial irradiation group). Distant metastases occurred in seven patients (four and three, respectively).

The 5-year overall survival rate was excellent, Dr. Livi noted: 97% in the whole breast irradiation group and 99% in the partial irradiation group.

Skin toxicity of any grade was significantly less common in the partial group (49 vs. 181). Significantly more patients in the partial irradiation group were completely free of adverse events (197 vs. 93). There were no grade 3 adverse events in either group. Two women in the whole breast irradiation group experienced a grade 2 toxicity- both of these were skin fibrosis.

Almost all patients (90%) reported good or excellent cosmetic results.

Dr. Livi fielded a few questions during the discussion period, one of which dealt with the cost of partial irradiation treatment. Since the procedure is more expensive, and the results similar, the discussant wondered whether it would be worth the additional cost. Dr Livi said the question is difficult for him to answer, because Italy’s national health care system does not charge patients for the treatment. He did say reimbursement for the treatments differs, but he did not elaborate.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – An accelerated course of partial breast irradiation was as effective as whole breast irradiation for women with early breast cancer, with significantly fewer adverse events.

The technique may be a suitable alternative for select patients who wish to minimize side effects without compromising clinical outcomes, Dr. Lorenzo Livi said at the San Antonio Breast Cancer Symposium.

He reported the 5-year results of an Italian study that randomized women with early breast cancer to one of two radiation regimens: conventional (tangential field) fractionated whole breast treatment or accelerated partial breast irradiation plus intensity-modulated radiotherapy.

Michele G. Sullivan/Frontline Medical News

The patients were highly selected, with a primary tumor size of less than 25 mm and negative surgical margins of more than 5 mm, said Dr. Livi, a radiation oncologist at the University of Florence, Italy.

The cohort comprised 520 women. Most (about 85%) were node-negative; 95% of the tumors were estrogen receptor–positive, and 90% were progesterone receptor–positive. The most frequent molecular subtype was luminal A (about 75%); less than 5% were triple-negative.

The median follow-up for this portion of the study was 5 years. There were six ipsilateral breast tumor recurrences – three in each group. There were three local relapses, all in the whole breast irradiation group. The 5-year recurrence rate was 1.4% in the whole breast irradiation group and 1.5% in the partial breast irradiation group. The mean time to ipsilateral breast recurrence was 3 years, and there was no significant between-group difference in this timing.

There were 10 contralateral recurrences (seven in the whole breast group vs. three in the partial irradiation group). Distant metastases occurred in seven patients (four and three, respectively).

The 5-year overall survival rate was excellent, Dr. Livi noted: 97% in the whole breast irradiation group and 99% in the partial irradiation group.

Skin toxicity of any grade was significantly less common in the partial group (49 vs. 181). Significantly more patients in the partial irradiation group were completely free of adverse events (197 vs. 93). There were no grade 3 adverse events in either group. Two women in the whole breast irradiation group experienced a grade 2 toxicity- both of these were skin fibrosis.

Almost all patients (90%) reported good or excellent cosmetic results.

Dr. Livi fielded a few questions during the discussion period, one of which dealt with the cost of partial irradiation treatment. Since the procedure is more expensive, and the results similar, the discussant wondered whether it would be worth the additional cost. Dr Livi said the question is difficult for him to answer, because Italy’s national health care system does not charge patients for the treatment. He did say reimbursement for the treatments differs, but he did not elaborate.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

SAN ANTONIO – Adding daily everolimus to weekly trastuzumab and paclitaxel as first-line therapy resulted in a median 7.2-month gain in progression-free survival in women with hormone receptor-negative, HER2+ advanced breast cancer in the Phase III BOLERO-1 trial.

Median progression-free survival was 20.27 months with the addition of everolimus (Afinitor) compared with 13.08 months with placebo in the 309 patients with hormone receptor-negative disease who participated in the randomized, double-blind study conducted at 141 centers in 28 countries, Dr. Sara A. Hurvitz reported at the San Antonio Breast Cancer Symposium. This translated to a 34% relative risk reduction for disease progression in patients randomized to everolimus, an oral mTOR inhibitor (P = .0049). However, this seemingly robust outcome did not actually achieve statistical significance. Since this was a subgroup analysis -- the other 410 participants in BOLERO-1 had hormone receptor-positive, HER2+ advanced breast cancer -- the prespecified threshold for significance set by the study statisticians for the analysis in hormone receptor-negative patients was P = .0044.

An Australian statistician rose from the audience to take issue with the BOLERO-1 statisticians in setting the bar for statistical significance so high.

“This was a statistical decision that was made. We’re all thinking about that,” admitted Dr. Hurvitz, director of the breast oncology program in the division of hematology-oncology at the University of California, Los Angeles.

Everolimus showed no benefit in the full study population, where median progression-free survival was virtually identical in the two treatment arms: 14.95 months with everolimus at 10 mg daily, 14.49 months with placebo.

Trastuzumab (Herceptin) has dramatically improved outcomes in patients diagnosed with HER2+ breast cancer, both in the early-stage and advanced settings. But not everyone benefits.

“Resistance to treatment remains a major clinical unmet challenge,” she observed.

The rationale for BOLERO-1 was that hyperactivation of the P13 kinase/mTOR pathway is one likely mechanism for HER2 resistance, and therefore an mTOR inhibitor such as everolimus might close off this resistance.

The most common adverse events associated with everolimus in BOLERO-1 were stomatitis, diarrhea, neutropenia, and anemia.

Of greater concern was the 3.6% mortality due to adverse events in the everolimus group compared with none in placebo-treated controls. Most of the deaths were due to pulmonary causes. Study leaders noticed that these deaths were occurring in centers with little experience in using everolimus. A letter was sent to all investigators underscoring the need for proactive aggressive management of adverse events in patients taking everolimus with chemotherapy; after that there was only a single additional death.

Dr. C. Kent Osborne commented that he thought it was a mistake for the BOLERO-1 investigators not to allow endocrine therapy in the patients with hormone receptor-positive disease.

“I think it’s important to add endocrine therapy because the estrogen receptor provides an immediate escape mechanism. If you don’t block it in a HER2+ tumor, the estrogen receptor can start activating and signaling the tumor cell to survive. It’s a very important issue,” said Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Hurvitz concurred.

“Now, with our retrospectoscope on, I think ongoing and future studies are going to be utilizing endocrine therapy with HER2-targeted therapy and P13 kinase inhibitors in this setting,” the oncologist said.

The BOLERO-1 trial was sponsored by Novartis. Dr. Hurvitz reported receiving research support from Genentech, Roche, and Novartis.

bjancin@frontlinemedcom.com

SAN ANTONIO – Adding daily everolimus to weekly trastuzumab and paclitaxel as first-line therapy resulted in a median 7.2-month gain in progression-free survival in women with hormone receptor-negative, HER2+ advanced breast cancer in the Phase III BOLERO-1 trial.

Median progression-free survival was 20.27 months with the addition of everolimus (Afinitor) compared with 13.08 months with placebo in the 309 patients with hormone receptor-negative disease who participated in the randomized, double-blind study conducted at 141 centers in 28 countries, Dr. Sara A. Hurvitz reported at the San Antonio Breast Cancer Symposium. This translated to a 34% relative risk reduction for disease progression in patients randomized to everolimus, an oral mTOR inhibitor (P = .0049). However, this seemingly robust outcome did not actually achieve statistical significance. Since this was a subgroup analysis -- the other 410 participants in BOLERO-1 had hormone receptor-positive, HER2+ advanced breast cancer -- the prespecified threshold for significance set by the study statisticians for the analysis in hormone receptor-negative patients was P = .0044.

An Australian statistician rose from the audience to take issue with the BOLERO-1 statisticians in setting the bar for statistical significance so high.

“This was a statistical decision that was made. We’re all thinking about that,” admitted Dr. Hurvitz, director of the breast oncology program in the division of hematology-oncology at the University of California, Los Angeles.

Everolimus showed no benefit in the full study population, where median progression-free survival was virtually identical in the two treatment arms: 14.95 months with everolimus at 10 mg daily, 14.49 months with placebo.

Trastuzumab (Herceptin) has dramatically improved outcomes in patients diagnosed with HER2+ breast cancer, both in the early-stage and advanced settings. But not everyone benefits.

“Resistance to treatment remains a major clinical unmet challenge,” she observed.

The rationale for BOLERO-1 was that hyperactivation of the P13 kinase/mTOR pathway is one likely mechanism for HER2 resistance, and therefore an mTOR inhibitor such as everolimus might close off this resistance.

The most common adverse events associated with everolimus in BOLERO-1 were stomatitis, diarrhea, neutropenia, and anemia.

Of greater concern was the 3.6% mortality due to adverse events in the everolimus group compared with none in placebo-treated controls. Most of the deaths were due to pulmonary causes. Study leaders noticed that these deaths were occurring in centers with little experience in using everolimus. A letter was sent to all investigators underscoring the need for proactive aggressive management of adverse events in patients taking everolimus with chemotherapy; after that there was only a single additional death.

Dr. C. Kent Osborne commented that he thought it was a mistake for the BOLERO-1 investigators not to allow endocrine therapy in the patients with hormone receptor-positive disease.

“I think it’s important to add endocrine therapy because the estrogen receptor provides an immediate escape mechanism. If you don’t block it in a HER2+ tumor, the estrogen receptor can start activating and signaling the tumor cell to survive. It’s a very important issue,” said Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Hurvitz concurred.

“Now, with our retrospectoscope on, I think ongoing and future studies are going to be utilizing endocrine therapy with HER2-targeted therapy and P13 kinase inhibitors in this setting,” the oncologist said.

The BOLERO-1 trial was sponsored by Novartis. Dr. Hurvitz reported receiving research support from Genentech, Roche, and Novartis.

bjancin@frontlinemedcom.com

SAN ANTONIO – Adding daily everolimus to weekly trastuzumab and paclitaxel as first-line therapy resulted in a median 7.2-month gain in progression-free survival in women with hormone receptor-negative, HER2+ advanced breast cancer in the Phase III BOLERO-1 trial.

Median progression-free survival was 20.27 months with the addition of everolimus (Afinitor) compared with 13.08 months with placebo in the 309 patients with hormone receptor-negative disease who participated in the randomized, double-blind study conducted at 141 centers in 28 countries, Dr. Sara A. Hurvitz reported at the San Antonio Breast Cancer Symposium. This translated to a 34% relative risk reduction for disease progression in patients randomized to everolimus, an oral mTOR inhibitor (P = .0049). However, this seemingly robust outcome did not actually achieve statistical significance. Since this was a subgroup analysis -- the other 410 participants in BOLERO-1 had hormone receptor-positive, HER2+ advanced breast cancer -- the prespecified threshold for significance set by the study statisticians for the analysis in hormone receptor-negative patients was P = .0044.

An Australian statistician rose from the audience to take issue with the BOLERO-1 statisticians in setting the bar for statistical significance so high.

“This was a statistical decision that was made. We’re all thinking about that,” admitted Dr. Hurvitz, director of the breast oncology program in the division of hematology-oncology at the University of California, Los Angeles.

Everolimus showed no benefit in the full study population, where median progression-free survival was virtually identical in the two treatment arms: 14.95 months with everolimus at 10 mg daily, 14.49 months with placebo.

Trastuzumab (Herceptin) has dramatically improved outcomes in patients diagnosed with HER2+ breast cancer, both in the early-stage and advanced settings. But not everyone benefits.

“Resistance to treatment remains a major clinical unmet challenge,” she observed.

The rationale for BOLERO-1 was that hyperactivation of the P13 kinase/mTOR pathway is one likely mechanism for HER2 resistance, and therefore an mTOR inhibitor such as everolimus might close off this resistance.

The most common adverse events associated with everolimus in BOLERO-1 were stomatitis, diarrhea, neutropenia, and anemia.

Of greater concern was the 3.6% mortality due to adverse events in the everolimus group compared with none in placebo-treated controls. Most of the deaths were due to pulmonary causes. Study leaders noticed that these deaths were occurring in centers with little experience in using everolimus. A letter was sent to all investigators underscoring the need for proactive aggressive management of adverse events in patients taking everolimus with chemotherapy; after that there was only a single additional death.

Dr. C. Kent Osborne commented that he thought it was a mistake for the BOLERO-1 investigators not to allow endocrine therapy in the patients with hormone receptor-positive disease.

“I think it’s important to add endocrine therapy because the estrogen receptor provides an immediate escape mechanism. If you don’t block it in a HER2+ tumor, the estrogen receptor can start activating and signaling the tumor cell to survive. It’s a very important issue,” said Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Hurvitz concurred.

“Now, with our retrospectoscope on, I think ongoing and future studies are going to be utilizing endocrine therapy with HER2-targeted therapy and P13 kinase inhibitors in this setting,” the oncologist said.

The BOLERO-1 trial was sponsored by Novartis. Dr. Hurvitz reported receiving research support from Genentech, Roche, and Novartis.

bjancin@frontlinemedcom.com

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SAN ANTONIO – The Oncology Report associate editors Dr. William J. Gradishar and Dr. Hope S. Rugo discuss highlights presented at the 2014 San Antonio Breast Cancer Symposium.

First reports on checkpoint inhibitors for the treatment of breast cancer, the unique study issues to consider in investigating these immunotherapy options, disappointing results from the FERGI trial, which looked at a combination therapy with a PI3 kinase inhibitor, and overall survival data from the FIRST trial of endocrine therapy with fulvestrant for patients with advanced disease were some of the topics Dr. Gradishar and Dr. Rugo weighed in on during the discussion.

The TNT trial comparing carboplatin to docetaxel in treating patients with triple-negative breast cancer; the latest results from the SOFT trial, looking at ovarian suppression in combination with either an aromatase inhibitor or tamoxifen; and the mixed results from BOLERO-1 looking at the addition of an mTOR inhibitor to the treatment of patients with advanced HER2-positive disease were also discussed.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at the Northwestern University, Chicago. Dr. Rugo is a professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center.

SAN ANTONIO – The Oncology Report associate editors Dr. William J. Gradishar and Dr. Hope S. Rugo discuss highlights presented at the 2014 San Antonio Breast Cancer Symposium.

First reports on checkpoint inhibitors for the treatment of breast cancer, the unique study issues to consider in investigating these immunotherapy options, disappointing results from the FERGI trial, which looked at a combination therapy with a PI3 kinase inhibitor, and overall survival data from the FIRST trial of endocrine therapy with fulvestrant for patients with advanced disease were some of the topics Dr. Gradishar and Dr. Rugo weighed in on during the discussion.

The TNT trial comparing carboplatin to docetaxel in treating patients with triple-negative breast cancer; the latest results from the SOFT trial, looking at ovarian suppression in combination with either an aromatase inhibitor or tamoxifen; and the mixed results from BOLERO-1 looking at the addition of an mTOR inhibitor to the treatment of patients with advanced HER2-positive disease were also discussed.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at the Northwestern University, Chicago. Dr. Rugo is a professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center.

SAN ANTONIO – The Oncology Report associate editors Dr. William J. Gradishar and Dr. Hope S. Rugo discuss highlights presented at the 2014 San Antonio Breast Cancer Symposium.

First reports on checkpoint inhibitors for the treatment of breast cancer, the unique study issues to consider in investigating these immunotherapy options, disappointing results from the FERGI trial, which looked at a combination therapy with a PI3 kinase inhibitor, and overall survival data from the FIRST trial of endocrine therapy with fulvestrant for patients with advanced disease were some of the topics Dr. Gradishar and Dr. Rugo weighed in on during the discussion.

The TNT trial comparing carboplatin to docetaxel in treating patients with triple-negative breast cancer; the latest results from the SOFT trial, looking at ovarian suppression in combination with either an aromatase inhibitor or tamoxifen; and the mixed results from BOLERO-1 looking at the addition of an mTOR inhibitor to the treatment of patients with advanced HER2-positive disease were also discussed.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at the Northwestern University, Chicago. Dr. Rugo is a professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center.

SAN ANTONIO – Fulvestrant resulted in a 30% improvement in overall survival, compared with anastrozole as first-line therapy for postmenopausal women with hormone receptor–positive advanced or metastatic breast cancer in the randomized FIRST trial.

This new finding follows upon a previously reported 34% reduction in the risk of disease progression in an earlier FIRST analysis. Plus, significant improvements in both disease progression and overall survival were seen with fulvestrant at 500 mg as second-line endocrine therapy in the Phase III CONFIRM (Comparison of Faslodex in Recurrent or Metastatic Breast Cancer) trial (J. Natl. Cancer Inst. Jan 2014;106:djt337 [doi:10.1093/jnci/djt337]). The clinical performance of fulvestrant in these two studies outpaces that of any other endocrine therapy for advanced breast cancer, Dr. John Robertson observed in presenting the new FIRST overall survival results at the San Antonio Breast Cancer Symposium.

“I don’t know of any other endocrine therapy where you can see both a time-to-progression and overall survival benefit in both the second- and first-line settings. So I think this is a new and exciting development in endocrine therapy for women with advanced breast cancer,” declared Dr. John Robertson, professor of surgery at the University of Nottingham, England.

FIRST (Fulvestrant First-line Study Comparing Endocrine Treatments) was a phase II, open-label study involving 205 women randomized to intramuscular fulvestrant (Faslodex) at 500 mg once monthly or the aromatase inhibitor anastrozole (Arimidex) at 1 mg/day orally. Aromatase inhibitors have been considered the standard therapy in this setting.

At a median follow-up of 48.8 months, the median overall survival was 54.1 months in the fulvestrant arm, compared with 48.4 months with anastrozole, for a 5.7-month advantage in favor of fulvestrant. This translated to a 30% reduction in the risk of death in the fulvestrant group (P = .041), which Dr. Robertson believes patients and their families will consider highly clinically meaningful.

“When I first started taking care of breast cancer patients like these 30 years ago, the average survival was 24 months. In this study, with fulvestrant it’s 54 months. We’re seeing step-by-step improvements,” he commented.

The advantage in overall survival seen with fulvestrant was consistent across all predefined subgroups based upon age, prior chemotherapy or endocrine therapy, visceral involvement status, and progesterone receptor status.

Both treatments were generally well tolerated, with no new safety concerns observed.

“Fulvestrant is a drug that’s really well tolerated. I can’t think of another medication in oncology where you can double the dose – from 250 to 500 mg – with no increase in side effects,” Dr. Robertson observed.

Now underway is the phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy–Naive Advanced Breast Cancer) trial, in which 450 hormone therapy–naive women with advanced breast cancer are being randomized to fulvestrant at 500 mg or anastrozole.

Dr. C. Kent Osborne commented, “Many people, including myself, have thought since the time fulvestrant was developed in the lab that it was the best endocrine therapy that we have.” But the drug “has had a checkered past,” he noted, citing the inconvenience of the required once-monthly intramuscular injections, plus the fact that early studies of fulvestrant as adjuvant therapy in early breast cancer yielded unimpressive results because they used fulvestrant at 250 mg, which turned out to be the wrong dose.

“In view of the data from CONFIRM and FIRST, are there plans to bring fulvestrant back into the adjuvant setting?” asked Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Robertson replied that it’s now quite apparent that fulvestrant would likely outperform aromatase inhibitors or tamoxifen as adjuvant therapy in early breast cancer, but he doubts that AstraZeneca, which markets the selective estrogen receptor down-regulator, will sponsor the requisite clinical trials. It wouldn’t be commercially viable. Adjuvant breast cancer therapy trials take a long time to produce results, and the drug will be close to going off patent by then.

“It’s a study that’s crying out to be done given what we’ve seen here in the FIRST study, but I think it is unlikely to happen unless somebody like the NIH takes on the funding,” Dr. Robertson said.

Pharmaceutical companies are now developing next-generation selective estrogen receptor down-regulators that can be given orally. They’re so new that it’s not yet known whether they’re actually effective, but if they are, they’ll be the ones studied as adjuvant therapy in clinical trials, not fulvestrant, he predicted.

“I’m skeptical,” said Dr. Osborne. “Trying to develop a better fulvestrant might work, but remember that after tamoxifen came out many, many companies tried to develop a better tamoxifen – and here we are with tamoxifen 40 years later.”

The FIRST trial was funded by AstraZeneca. Dr. Robertson reported serving as a consultant to that company as well as Bayer HealthCare and receiving research funding from both companies along with Amgen and Novartis.

bjancin@frontlinemedcom.com

SAN ANTONIO – Fulvestrant resulted in a 30% improvement in overall survival, compared with anastrozole as first-line therapy for postmenopausal women with hormone receptor–positive advanced or metastatic breast cancer in the randomized FIRST trial.

This new finding follows upon a previously reported 34% reduction in the risk of disease progression in an earlier FIRST analysis. Plus, significant improvements in both disease progression and overall survival were seen with fulvestrant at 500 mg as second-line endocrine therapy in the Phase III CONFIRM (Comparison of Faslodex in Recurrent or Metastatic Breast Cancer) trial (J. Natl. Cancer Inst. Jan 2014;106:djt337 [doi:10.1093/jnci/djt337]). The clinical performance of fulvestrant in these two studies outpaces that of any other endocrine therapy for advanced breast cancer, Dr. John Robertson observed in presenting the new FIRST overall survival results at the San Antonio Breast Cancer Symposium.

“I don’t know of any other endocrine therapy where you can see both a time-to-progression and overall survival benefit in both the second- and first-line settings. So I think this is a new and exciting development in endocrine therapy for women with advanced breast cancer,” declared Dr. John Robertson, professor of surgery at the University of Nottingham, England.

FIRST (Fulvestrant First-line Study Comparing Endocrine Treatments) was a phase II, open-label study involving 205 women randomized to intramuscular fulvestrant (Faslodex) at 500 mg once monthly or the aromatase inhibitor anastrozole (Arimidex) at 1 mg/day orally. Aromatase inhibitors have been considered the standard therapy in this setting.

At a median follow-up of 48.8 months, the median overall survival was 54.1 months in the fulvestrant arm, compared with 48.4 months with anastrozole, for a 5.7-month advantage in favor of fulvestrant. This translated to a 30% reduction in the risk of death in the fulvestrant group (P = .041), which Dr. Robertson believes patients and their families will consider highly clinically meaningful.

“When I first started taking care of breast cancer patients like these 30 years ago, the average survival was 24 months. In this study, with fulvestrant it’s 54 months. We’re seeing step-by-step improvements,” he commented.

The advantage in overall survival seen with fulvestrant was consistent across all predefined subgroups based upon age, prior chemotherapy or endocrine therapy, visceral involvement status, and progesterone receptor status.

Both treatments were generally well tolerated, with no new safety concerns observed.

“Fulvestrant is a drug that’s really well tolerated. I can’t think of another medication in oncology where you can double the dose – from 250 to 500 mg – with no increase in side effects,” Dr. Robertson observed.

Now underway is the phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy–Naive Advanced Breast Cancer) trial, in which 450 hormone therapy–naive women with advanced breast cancer are being randomized to fulvestrant at 500 mg or anastrozole.

Dr. C. Kent Osborne commented, “Many people, including myself, have thought since the time fulvestrant was developed in the lab that it was the best endocrine therapy that we have.” But the drug “has had a checkered past,” he noted, citing the inconvenience of the required once-monthly intramuscular injections, plus the fact that early studies of fulvestrant as adjuvant therapy in early breast cancer yielded unimpressive results because they used fulvestrant at 250 mg, which turned out to be the wrong dose.

“In view of the data from CONFIRM and FIRST, are there plans to bring fulvestrant back into the adjuvant setting?” asked Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Robertson replied that it’s now quite apparent that fulvestrant would likely outperform aromatase inhibitors or tamoxifen as adjuvant therapy in early breast cancer, but he doubts that AstraZeneca, which markets the selective estrogen receptor down-regulator, will sponsor the requisite clinical trials. It wouldn’t be commercially viable. Adjuvant breast cancer therapy trials take a long time to produce results, and the drug will be close to going off patent by then.

“It’s a study that’s crying out to be done given what we’ve seen here in the FIRST study, but I think it is unlikely to happen unless somebody like the NIH takes on the funding,” Dr. Robertson said.

Pharmaceutical companies are now developing next-generation selective estrogen receptor down-regulators that can be given orally. They’re so new that it’s not yet known whether they’re actually effective, but if they are, they’ll be the ones studied as adjuvant therapy in clinical trials, not fulvestrant, he predicted.

“I’m skeptical,” said Dr. Osborne. “Trying to develop a better fulvestrant might work, but remember that after tamoxifen came out many, many companies tried to develop a better tamoxifen – and here we are with tamoxifen 40 years later.”

The FIRST trial was funded by AstraZeneca. Dr. Robertson reported serving as a consultant to that company as well as Bayer HealthCare and receiving research funding from both companies along with Amgen and Novartis.

bjancin@frontlinemedcom.com

SAN ANTONIO – Fulvestrant resulted in a 30% improvement in overall survival, compared with anastrozole as first-line therapy for postmenopausal women with hormone receptor–positive advanced or metastatic breast cancer in the randomized FIRST trial.

This new finding follows upon a previously reported 34% reduction in the risk of disease progression in an earlier FIRST analysis. Plus, significant improvements in both disease progression and overall survival were seen with fulvestrant at 500 mg as second-line endocrine therapy in the Phase III CONFIRM (Comparison of Faslodex in Recurrent or Metastatic Breast Cancer) trial (J. Natl. Cancer Inst. Jan 2014;106:djt337 [doi:10.1093/jnci/djt337]). The clinical performance of fulvestrant in these two studies outpaces that of any other endocrine therapy for advanced breast cancer, Dr. John Robertson observed in presenting the new FIRST overall survival results at the San Antonio Breast Cancer Symposium.

“I don’t know of any other endocrine therapy where you can see both a time-to-progression and overall survival benefit in both the second- and first-line settings. So I think this is a new and exciting development in endocrine therapy for women with advanced breast cancer,” declared Dr. John Robertson, professor of surgery at the University of Nottingham, England.

FIRST (Fulvestrant First-line Study Comparing Endocrine Treatments) was a phase II, open-label study involving 205 women randomized to intramuscular fulvestrant (Faslodex) at 500 mg once monthly or the aromatase inhibitor anastrozole (Arimidex) at 1 mg/day orally. Aromatase inhibitors have been considered the standard therapy in this setting.

At a median follow-up of 48.8 months, the median overall survival was 54.1 months in the fulvestrant arm, compared with 48.4 months with anastrozole, for a 5.7-month advantage in favor of fulvestrant. This translated to a 30% reduction in the risk of death in the fulvestrant group (P = .041), which Dr. Robertson believes patients and their families will consider highly clinically meaningful.

“When I first started taking care of breast cancer patients like these 30 years ago, the average survival was 24 months. In this study, with fulvestrant it’s 54 months. We’re seeing step-by-step improvements,” he commented.

The advantage in overall survival seen with fulvestrant was consistent across all predefined subgroups based upon age, prior chemotherapy or endocrine therapy, visceral involvement status, and progesterone receptor status.

Both treatments were generally well tolerated, with no new safety concerns observed.

“Fulvestrant is a drug that’s really well tolerated. I can’t think of another medication in oncology where you can double the dose – from 250 to 500 mg – with no increase in side effects,” Dr. Robertson observed.

Now underway is the phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy–Naive Advanced Breast Cancer) trial, in which 450 hormone therapy–naive women with advanced breast cancer are being randomized to fulvestrant at 500 mg or anastrozole.

Dr. C. Kent Osborne commented, “Many people, including myself, have thought since the time fulvestrant was developed in the lab that it was the best endocrine therapy that we have.” But the drug “has had a checkered past,” he noted, citing the inconvenience of the required once-monthly intramuscular injections, plus the fact that early studies of fulvestrant as adjuvant therapy in early breast cancer yielded unimpressive results because they used fulvestrant at 250 mg, which turned out to be the wrong dose.

“In view of the data from CONFIRM and FIRST, are there plans to bring fulvestrant back into the adjuvant setting?” asked Dr. Osborne, professor of medicine and director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston.

Dr. Robertson replied that it’s now quite apparent that fulvestrant would likely outperform aromatase inhibitors or tamoxifen as adjuvant therapy in early breast cancer, but he doubts that AstraZeneca, which markets the selective estrogen receptor down-regulator, will sponsor the requisite clinical trials. It wouldn’t be commercially viable. Adjuvant breast cancer therapy trials take a long time to produce results, and the drug will be close to going off patent by then.

“It’s a study that’s crying out to be done given what we’ve seen here in the FIRST study, but I think it is unlikely to happen unless somebody like the NIH takes on the funding,” Dr. Robertson said.

Pharmaceutical companies are now developing next-generation selective estrogen receptor down-regulators that can be given orally. They’re so new that it’s not yet known whether they’re actually effective, but if they are, they’ll be the ones studied as adjuvant therapy in clinical trials, not fulvestrant, he predicted.

“I’m skeptical,” said Dr. Osborne. “Trying to develop a better fulvestrant might work, but remember that after tamoxifen came out many, many companies tried to develop a better tamoxifen – and here we are with tamoxifen 40 years later.”

The FIRST trial was funded by AstraZeneca. Dr. Robertson reported serving as a consultant to that company as well as Bayer HealthCare and receiving research funding from both companies along with Amgen and Novartis.

bjancin@frontlinemedcom.com