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Post-lumpectomy radiotherapy benefits good-risk DCIS patients
The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.
Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.
Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).
Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.
The women were followed for a median of 7.2 years.
Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.
Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.
“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.
The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.
These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.
However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.
This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.
The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.
Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.
Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).
Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.
The women were followed for a median of 7.2 years.
Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.
Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.
“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.
The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.
These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.
However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.
This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.
The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.
Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.
Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).
Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.
The women were followed for a median of 7.2 years.
Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.
Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.
“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.
The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.
These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.
However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.
This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.
Key clinical point: Foregoing adjuvant radiotherapy after breast-conserving surgery is a reasonable choice, but radiotherapy provides significant benefit with respect to reducing the local failure risk.
Major finding: The cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the observation and radiotherapy groups, respectively (HR, 0.11)
Data source: A prospective randomized trial involving 585 women.
Disclosures: This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.
Immune function genes may predict trastuzumab response
Early-stage HER2-positive breast cancers that overexpress a subset of genes involved in the regulation of immune function are much more likely to respond to adjuvant trastuzumab therapy than breast cancers that do not express those genes, according to a report published online Jan. 19 in Journal of Clinical Oncology.
This finding from a secondary analysis of tumor samples obtained in a phase III clinical trial represents “the first demonstration of a cohort of immune function genes that seem to predict benefit from adjuvant trastuzumab,” said Dr. Edith A. Perez of Mayo Clinic, Jacksonville, Fla., and her associates.
The original trial “was one of several large studies that helped define the standard of care for patients with early-stage HER2-positive breast cancer,” demonstrating that adding trastuzumab to adjuvant chemotherapy was effective at preventing recurrences. However, 20%-25% of women with these tumors still relapse despite this targeted approach, and a biomarker to identify this subset of nonresponders is urgently needed, the investigators said (J. Clin. Oncol. 2015 Jan. 19. [doi:10.1200/JCO.2014.57.6298]).
To identify such a biomarker, they performed whole transcriptome analysis of 1,282 breast cancer samples collected in the trial that were evaluable for gene expression profiling. A total of 433 of the cancers had been treated with anthracycline plus cyclophosphamide, followed by paclitaxel. The remaining cancers had been treated with anthracycline plus cyclophosphamide followed by paclitaxel, then trastuzumab (477 tumors) or anthracycline plus cyclophosphamide followed by concurrent paclitaxel plus trastuzumab (372 tumors). There were 204 cancer recurrences overall.
The investigators identified 485 genes expressed by the cancers that were significantly associated with recurrence-free survival and discovered that certain genes linked to immune functions – including T- and B-cell responses, chemokine signaling, chemotaxis, and inflammation – predicted higher recurrence-free survival only in women treated with trastuzumab. They then built a predictive genetic signature comprising 14 genes related to immune function, which was used to designate which tumors were immune response enriched (IRE) and which were non–immune response enriched (NIRE).
Recurrence-free survival was significantly better for women with IRE tumors who received trastuzumab, compared with those who received chemotherapy alone, with a hazard ratio of 0.36. In contrast, recurrence-free survival was no different between women with NIRE tumors who received trastuzumab and those who received chemotherapy alone.
“Our data indicate that a subset of HER2-positive tumors likely manifests a high level of immunologic activity, as evidenced by expression of a diverse cohort of immune function genes.” Thus, the study results suggest that “benefit from adjuvant trastuzumab, beyond the benefit conveyed by chemotherapy alone, may reside largely within this cohort of immune-enriched tumors,” Dr. Perez and her associates said.
It is hoped that these findings, if confirmed in larger studies, can be used to predict which patients would most benefit from trastuzumab. More important, other approaches could be devised for treating patients with NIRE tumors who wouldn’t respond to trastuzumab and who are at high risk for recurrence. Perhaps enhancing the decreased immune activity of their cancers could sensitize the tumors to further biologic therapy, the investigators added.
Perez et al. contribute substantially to existing knowledge and support previous preclinical and clinical results suggesting that the immune system is crucial in modulating treatment response in breast cancer.
The immune signature they report clearly is not yet ready for routine clinical application and must be independently confirmed in other studies. Once that is done, it can be used to identify which patients can be spared from trastuzumab therapy. More important, it points the way to novel treatment strategies for this patient population, possibly by using immune-modulating agents to enhance the tumor’s immune response.
John A. Foekens, Ph.D., John W. M. Martens, Ph.D., and Stefan Sleijfer, M.D., Ph.D., are at Erasmus Medical Center Cancer Institute and Erasmus University Medical Center, Rotterdam, the Netherlands. Dr. Foekens and Dr. Martens reported having no financial conflicts of interest; Dr. Sleijfer reported ties to Bayer, GlaxoSmithKline, Merck Serono, and Novartis. Dr. Foekens, Dr. Martens, and Dr. Sleijfer made these remarks in an editorial accompanying Dr. Perez’s report (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/jco.2014.59.5058]).
Perez et al. contribute substantially to existing knowledge and support previous preclinical and clinical results suggesting that the immune system is crucial in modulating treatment response in breast cancer.
The immune signature they report clearly is not yet ready for routine clinical application and must be independently confirmed in other studies. Once that is done, it can be used to identify which patients can be spared from trastuzumab therapy. More important, it points the way to novel treatment strategies for this patient population, possibly by using immune-modulating agents to enhance the tumor’s immune response.
John A. Foekens, Ph.D., John W. M. Martens, Ph.D., and Stefan Sleijfer, M.D., Ph.D., are at Erasmus Medical Center Cancer Institute and Erasmus University Medical Center, Rotterdam, the Netherlands. Dr. Foekens and Dr. Martens reported having no financial conflicts of interest; Dr. Sleijfer reported ties to Bayer, GlaxoSmithKline, Merck Serono, and Novartis. Dr. Foekens, Dr. Martens, and Dr. Sleijfer made these remarks in an editorial accompanying Dr. Perez’s report (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/jco.2014.59.5058]).
Perez et al. contribute substantially to existing knowledge and support previous preclinical and clinical results suggesting that the immune system is crucial in modulating treatment response in breast cancer.
The immune signature they report clearly is not yet ready for routine clinical application and must be independently confirmed in other studies. Once that is done, it can be used to identify which patients can be spared from trastuzumab therapy. More important, it points the way to novel treatment strategies for this patient population, possibly by using immune-modulating agents to enhance the tumor’s immune response.
John A. Foekens, Ph.D., John W. M. Martens, Ph.D., and Stefan Sleijfer, M.D., Ph.D., are at Erasmus Medical Center Cancer Institute and Erasmus University Medical Center, Rotterdam, the Netherlands. Dr. Foekens and Dr. Martens reported having no financial conflicts of interest; Dr. Sleijfer reported ties to Bayer, GlaxoSmithKline, Merck Serono, and Novartis. Dr. Foekens, Dr. Martens, and Dr. Sleijfer made these remarks in an editorial accompanying Dr. Perez’s report (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/jco.2014.59.5058]).
Early-stage HER2-positive breast cancers that overexpress a subset of genes involved in the regulation of immune function are much more likely to respond to adjuvant trastuzumab therapy than breast cancers that do not express those genes, according to a report published online Jan. 19 in Journal of Clinical Oncology.
This finding from a secondary analysis of tumor samples obtained in a phase III clinical trial represents “the first demonstration of a cohort of immune function genes that seem to predict benefit from adjuvant trastuzumab,” said Dr. Edith A. Perez of Mayo Clinic, Jacksonville, Fla., and her associates.
The original trial “was one of several large studies that helped define the standard of care for patients with early-stage HER2-positive breast cancer,” demonstrating that adding trastuzumab to adjuvant chemotherapy was effective at preventing recurrences. However, 20%-25% of women with these tumors still relapse despite this targeted approach, and a biomarker to identify this subset of nonresponders is urgently needed, the investigators said (J. Clin. Oncol. 2015 Jan. 19. [doi:10.1200/JCO.2014.57.6298]).
To identify such a biomarker, they performed whole transcriptome analysis of 1,282 breast cancer samples collected in the trial that were evaluable for gene expression profiling. A total of 433 of the cancers had been treated with anthracycline plus cyclophosphamide, followed by paclitaxel. The remaining cancers had been treated with anthracycline plus cyclophosphamide followed by paclitaxel, then trastuzumab (477 tumors) or anthracycline plus cyclophosphamide followed by concurrent paclitaxel plus trastuzumab (372 tumors). There were 204 cancer recurrences overall.
The investigators identified 485 genes expressed by the cancers that were significantly associated with recurrence-free survival and discovered that certain genes linked to immune functions – including T- and B-cell responses, chemokine signaling, chemotaxis, and inflammation – predicted higher recurrence-free survival only in women treated with trastuzumab. They then built a predictive genetic signature comprising 14 genes related to immune function, which was used to designate which tumors were immune response enriched (IRE) and which were non–immune response enriched (NIRE).
Recurrence-free survival was significantly better for women with IRE tumors who received trastuzumab, compared with those who received chemotherapy alone, with a hazard ratio of 0.36. In contrast, recurrence-free survival was no different between women with NIRE tumors who received trastuzumab and those who received chemotherapy alone.
“Our data indicate that a subset of HER2-positive tumors likely manifests a high level of immunologic activity, as evidenced by expression of a diverse cohort of immune function genes.” Thus, the study results suggest that “benefit from adjuvant trastuzumab, beyond the benefit conveyed by chemotherapy alone, may reside largely within this cohort of immune-enriched tumors,” Dr. Perez and her associates said.
It is hoped that these findings, if confirmed in larger studies, can be used to predict which patients would most benefit from trastuzumab. More important, other approaches could be devised for treating patients with NIRE tumors who wouldn’t respond to trastuzumab and who are at high risk for recurrence. Perhaps enhancing the decreased immune activity of their cancers could sensitize the tumors to further biologic therapy, the investigators added.
Early-stage HER2-positive breast cancers that overexpress a subset of genes involved in the regulation of immune function are much more likely to respond to adjuvant trastuzumab therapy than breast cancers that do not express those genes, according to a report published online Jan. 19 in Journal of Clinical Oncology.
This finding from a secondary analysis of tumor samples obtained in a phase III clinical trial represents “the first demonstration of a cohort of immune function genes that seem to predict benefit from adjuvant trastuzumab,” said Dr. Edith A. Perez of Mayo Clinic, Jacksonville, Fla., and her associates.
The original trial “was one of several large studies that helped define the standard of care for patients with early-stage HER2-positive breast cancer,” demonstrating that adding trastuzumab to adjuvant chemotherapy was effective at preventing recurrences. However, 20%-25% of women with these tumors still relapse despite this targeted approach, and a biomarker to identify this subset of nonresponders is urgently needed, the investigators said (J. Clin. Oncol. 2015 Jan. 19. [doi:10.1200/JCO.2014.57.6298]).
To identify such a biomarker, they performed whole transcriptome analysis of 1,282 breast cancer samples collected in the trial that were evaluable for gene expression profiling. A total of 433 of the cancers had been treated with anthracycline plus cyclophosphamide, followed by paclitaxel. The remaining cancers had been treated with anthracycline plus cyclophosphamide followed by paclitaxel, then trastuzumab (477 tumors) or anthracycline plus cyclophosphamide followed by concurrent paclitaxel plus trastuzumab (372 tumors). There were 204 cancer recurrences overall.
The investigators identified 485 genes expressed by the cancers that were significantly associated with recurrence-free survival and discovered that certain genes linked to immune functions – including T- and B-cell responses, chemokine signaling, chemotaxis, and inflammation – predicted higher recurrence-free survival only in women treated with trastuzumab. They then built a predictive genetic signature comprising 14 genes related to immune function, which was used to designate which tumors were immune response enriched (IRE) and which were non–immune response enriched (NIRE).
Recurrence-free survival was significantly better for women with IRE tumors who received trastuzumab, compared with those who received chemotherapy alone, with a hazard ratio of 0.36. In contrast, recurrence-free survival was no different between women with NIRE tumors who received trastuzumab and those who received chemotherapy alone.
“Our data indicate that a subset of HER2-positive tumors likely manifests a high level of immunologic activity, as evidenced by expression of a diverse cohort of immune function genes.” Thus, the study results suggest that “benefit from adjuvant trastuzumab, beyond the benefit conveyed by chemotherapy alone, may reside largely within this cohort of immune-enriched tumors,” Dr. Perez and her associates said.
It is hoped that these findings, if confirmed in larger studies, can be used to predict which patients would most benefit from trastuzumab. More important, other approaches could be devised for treating patients with NIRE tumors who wouldn’t respond to trastuzumab and who are at high risk for recurrence. Perhaps enhancing the decreased immune activity of their cancers could sensitize the tumors to further biologic therapy, the investigators added.
Key clinical point: Breast cancers that overexpress certain immune function genes are much more likely to respond to trastuzumab therapy than cancers that do not.
Major finding: Recurrence-free survival was significantly better for women with immune response–enriched tumors who received trastuzumab, compared with those who received chemotherapy alone, with a hazard ratio of 0.36.
Data source: A secondary analysis of tumor samples from 1,282 participants in a phase III adjuvant chemotherapy trial, to identify a genomic signature that would predict response to trastuzumab.
Disclosures: This study was supported by the National Cancer Institute, the Breast Cancer Research Foundation, the 26.2 With Donna Foundation, the National Institutes of Health, the Mayo Clinic Comprehensive Cancer Center, and the Mayo Foundation. Dr. Perez reported having no financial disclosures; her associates reported ties to Merck, Illumina, Syndax, Genetech, Symphogen, Verastem, Roche, Novartis, and Ventana Medical Systems.
Immunotherapy moves into the breast cancer landscape
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Radiation exposure from diagnostic procedures in patients with newly diagnosed breast cancer
Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.
Click on the PDF icon at the top of this introduction to read the full article.
Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.
Click on the PDF icon at the top of this introduction to read the full article.
Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.
Click on the PDF icon at the top of this introduction to read the full article.
Big savings achievable with evidence-based radiotherapy for breast Ca
SAN ANTONIO – Hefty reductions in annual health care spending for breast cancer therapy would be achieved if physicians increased their use of evidence-based adjuvant radiation therapy following lumpectomy for early-stage breast cancer, according to Dr. Rachel A. Greenup.
The potential savings would amount to $164 million annually, based on the American College of Surgeons National Cancer Data Base for the year 2011. And since that database captures only about 70% of all newly diagnosed cancers in the United States, that savings figure is likely an underestimate, according to Dr. Greenup, a surgical oncologist at Duke University, Durham, N.C.
She and her coinvestigators identified 43,247 women in the national database with clinically node-negative, T1-T2 invasive breast cancer treated by lumpectomy during 2011. Their median age was 63 years, with a median tumor size of 1.2 cm. Only 26% of women received the least expensive adjuvant radiation therapy for which they were potentially eligible based upon current guidelines and best practices. Sixty-seven percent of patients received more costly regimens.
Overall, 22% of the women were deemed by investigators to be eligible for no radiotherapy because they fit the criteria laid out in the CALGB (Cancer and Leukemia Group B) 9493 study: age 70 years or older, with T1N0, estrogen receptor–positive disease. CALGB 9493 demonstrated at median follow-ups of 5 years (N. Engl. J. Med. 2004;351:971-7) and 12.6 years (J. Clin. Oncol. 2013;31:2382-7) that women who fit that profile could safely forego radiotherapy.
The investigators considered another 62% of patients to be eligible for hypofractionated whole breast irradiation (HF-WBI), defined as 15-24 fractions at 40-58 Gy, as their least costly appropriate radiotherapy option because they were at least 50 years old with T1-T2 NO invasive breast cancer. Sixteen percent of patients were deemed eligible for conventional fractionated whole breast irradiation (CF-WBI) as their least expensive option.
Treatment costs were determined using the Medicare Physician Fee Schedule payment data for 2011 and the average procedural codes billed per regimen. The cost per patient was $13,358.37 for CF-WBI and $8,327.98 for HF-WBI.
Of the 9,651 women considered eligible for no radiation therapy, only 36% actually did not undergo irradiation. Forty-four percent had CF-WBI, 18% had HF-WBI, and the rest had accelerated partial breast irradiation. The total cost of radiation therapy in this subgroup was $72.2 million.
Among the considerably larger group for whom HF-WBI was deemed the least costly radiation therapy option for which they were eligible, 68% had CF-WBI, 17% had no radiotherapy, and only 6.5% received HF-WBI. The total cost of radiation therapy in this group was $276.8 million in 2011. Had they undergone evidence-based therapy, the cost would have dropped to $185 million, Dr. Greenup said at the San Antonio Breast Cancer Symposium.
For the 6,685 women who were considered candidates for CF-WBI, 75% received that form of radiation therapy, 7% got HF-WBI, and 18% received no radiotherapy. Their total radiation therapy costs amounted to $71.2 million.
The total estimated cost of actual radiation treatment in the study population was $420.2 million, compared with $256.2 million, or 39% less, had the women received the least expensive regimen for which they were eligible.
An estimated $125 billion is spent annually on cancer treatment in the United States, with breast cancer therapy accounting for the largest proportion of that, Dr. Greenup noted.
She reported having no relevant financial conflicts.
SAN ANTONIO – Hefty reductions in annual health care spending for breast cancer therapy would be achieved if physicians increased their use of evidence-based adjuvant radiation therapy following lumpectomy for early-stage breast cancer, according to Dr. Rachel A. Greenup.
The potential savings would amount to $164 million annually, based on the American College of Surgeons National Cancer Data Base for the year 2011. And since that database captures only about 70% of all newly diagnosed cancers in the United States, that savings figure is likely an underestimate, according to Dr. Greenup, a surgical oncologist at Duke University, Durham, N.C.
She and her coinvestigators identified 43,247 women in the national database with clinically node-negative, T1-T2 invasive breast cancer treated by lumpectomy during 2011. Their median age was 63 years, with a median tumor size of 1.2 cm. Only 26% of women received the least expensive adjuvant radiation therapy for which they were potentially eligible based upon current guidelines and best practices. Sixty-seven percent of patients received more costly regimens.
Overall, 22% of the women were deemed by investigators to be eligible for no radiotherapy because they fit the criteria laid out in the CALGB (Cancer and Leukemia Group B) 9493 study: age 70 years or older, with T1N0, estrogen receptor–positive disease. CALGB 9493 demonstrated at median follow-ups of 5 years (N. Engl. J. Med. 2004;351:971-7) and 12.6 years (J. Clin. Oncol. 2013;31:2382-7) that women who fit that profile could safely forego radiotherapy.
The investigators considered another 62% of patients to be eligible for hypofractionated whole breast irradiation (HF-WBI), defined as 15-24 fractions at 40-58 Gy, as their least costly appropriate radiotherapy option because they were at least 50 years old with T1-T2 NO invasive breast cancer. Sixteen percent of patients were deemed eligible for conventional fractionated whole breast irradiation (CF-WBI) as their least expensive option.
Treatment costs were determined using the Medicare Physician Fee Schedule payment data for 2011 and the average procedural codes billed per regimen. The cost per patient was $13,358.37 for CF-WBI and $8,327.98 for HF-WBI.
Of the 9,651 women considered eligible for no radiation therapy, only 36% actually did not undergo irradiation. Forty-four percent had CF-WBI, 18% had HF-WBI, and the rest had accelerated partial breast irradiation. The total cost of radiation therapy in this subgroup was $72.2 million.
Among the considerably larger group for whom HF-WBI was deemed the least costly radiation therapy option for which they were eligible, 68% had CF-WBI, 17% had no radiotherapy, and only 6.5% received HF-WBI. The total cost of radiation therapy in this group was $276.8 million in 2011. Had they undergone evidence-based therapy, the cost would have dropped to $185 million, Dr. Greenup said at the San Antonio Breast Cancer Symposium.
For the 6,685 women who were considered candidates for CF-WBI, 75% received that form of radiation therapy, 7% got HF-WBI, and 18% received no radiotherapy. Their total radiation therapy costs amounted to $71.2 million.
The total estimated cost of actual radiation treatment in the study population was $420.2 million, compared with $256.2 million, or 39% less, had the women received the least expensive regimen for which they were eligible.
An estimated $125 billion is spent annually on cancer treatment in the United States, with breast cancer therapy accounting for the largest proportion of that, Dr. Greenup noted.
She reported having no relevant financial conflicts.
SAN ANTONIO – Hefty reductions in annual health care spending for breast cancer therapy would be achieved if physicians increased their use of evidence-based adjuvant radiation therapy following lumpectomy for early-stage breast cancer, according to Dr. Rachel A. Greenup.
The potential savings would amount to $164 million annually, based on the American College of Surgeons National Cancer Data Base for the year 2011. And since that database captures only about 70% of all newly diagnosed cancers in the United States, that savings figure is likely an underestimate, according to Dr. Greenup, a surgical oncologist at Duke University, Durham, N.C.
She and her coinvestigators identified 43,247 women in the national database with clinically node-negative, T1-T2 invasive breast cancer treated by lumpectomy during 2011. Their median age was 63 years, with a median tumor size of 1.2 cm. Only 26% of women received the least expensive adjuvant radiation therapy for which they were potentially eligible based upon current guidelines and best practices. Sixty-seven percent of patients received more costly regimens.
Overall, 22% of the women were deemed by investigators to be eligible for no radiotherapy because they fit the criteria laid out in the CALGB (Cancer and Leukemia Group B) 9493 study: age 70 years or older, with T1N0, estrogen receptor–positive disease. CALGB 9493 demonstrated at median follow-ups of 5 years (N. Engl. J. Med. 2004;351:971-7) and 12.6 years (J. Clin. Oncol. 2013;31:2382-7) that women who fit that profile could safely forego radiotherapy.
The investigators considered another 62% of patients to be eligible for hypofractionated whole breast irradiation (HF-WBI), defined as 15-24 fractions at 40-58 Gy, as their least costly appropriate radiotherapy option because they were at least 50 years old with T1-T2 NO invasive breast cancer. Sixteen percent of patients were deemed eligible for conventional fractionated whole breast irradiation (CF-WBI) as their least expensive option.
Treatment costs were determined using the Medicare Physician Fee Schedule payment data for 2011 and the average procedural codes billed per regimen. The cost per patient was $13,358.37 for CF-WBI and $8,327.98 for HF-WBI.
Of the 9,651 women considered eligible for no radiation therapy, only 36% actually did not undergo irradiation. Forty-four percent had CF-WBI, 18% had HF-WBI, and the rest had accelerated partial breast irradiation. The total cost of radiation therapy in this subgroup was $72.2 million.
Among the considerably larger group for whom HF-WBI was deemed the least costly radiation therapy option for which they were eligible, 68% had CF-WBI, 17% had no radiotherapy, and only 6.5% received HF-WBI. The total cost of radiation therapy in this group was $276.8 million in 2011. Had they undergone evidence-based therapy, the cost would have dropped to $185 million, Dr. Greenup said at the San Antonio Breast Cancer Symposium.
For the 6,685 women who were considered candidates for CF-WBI, 75% received that form of radiation therapy, 7% got HF-WBI, and 18% received no radiotherapy. Their total radiation therapy costs amounted to $71.2 million.
The total estimated cost of actual radiation treatment in the study population was $420.2 million, compared with $256.2 million, or 39% less, had the women received the least expensive regimen for which they were eligible.
An estimated $125 billion is spent annually on cancer treatment in the United States, with breast cancer therapy accounting for the largest proportion of that, Dr. Greenup noted.
She reported having no relevant financial conflicts.
AT SABCS 2014
Key clinical point: The national cost of radiation therapy for breast cancer is inflated by the widespread practice of utilizing costlier regimens than warranted.
Major finding: The annual cost of adjuvant radiotherapy after lumpectomy for early-stage breast cancer in the United States could be reduced by 39%, or $164 million, if physicians used the least expensive evidence-based regimens.
Data source: A retrospective analysis of the American College of Surgeons National Cancer Data Base, which included more than 43,000 women with clinically node-negative, T1-T2 invasive breast cancer treated with lumpectomy in 2011.
Disclosures: The presenter reported having no financial conflicts regarding this study.
Adjuvant taxane benefit for breast cancer varies by subtype
SAN ANTONIO – Extended follow-up of the nearly 5,000 women enrolled in the phase III multicenter E1199 trial has provided a wealth of new findings – and additional leads – regarding optimal adjuvant chemotherapy in patients with axillary lymph node–positive or high-risk, lymph node–negative breast cancer.
“The relative effectiveness of weekly paclitaxel and every-3-week docetaxel may vary by subtype,” Dr. Joseph A. Sparano reported at the San Antonio Breast Cancer Symposium.
The E1199 trial, conducted in 1999-2001, included 4,950 breast cancer patients who first received four cycles of standard adjuvant chemotherapy consisting of intravenous doxorubicin and cyclophosphamide at 3-week intervals. They were then assigned in a 2x2 factorial design to intravenous paclitaxel (Abraxane) at the then-standard 3-week intervals for four cycles, to weekly paclitaxel for 12 weeks, or to docetaxel (Taxotere) given at either of the same two dosing schedules.
The goal was to determine the optimally effective adjuvant taxane and dosing regimen. And in the initial report based upon a median 5.3 years of follow-up (N. Engl. J. Med. 2008;358:1663-71), weekly paclitaxel was the clear winner. It was associated with a 27% improvement in the likelihood of disease-free survival (DFS) and a 32% gain in overall survival (OS), compared with paclitaxel given every 3 weeks. Docetaxel every 3 weeks also resulted in improved DFS, but not in OS.
Dr. Sparano’s newly updated analysis was based upon a median 12.1 years of follow-up. By this point the number of DFS events – defined as recurrence, contralateral breast cancer, or death – had climbed to 1,639, compared with 1,058 in the initial report. The all-cause death count had risen from 686 to 1,283.
With the extended follow-up, both weekly paclitaxel and docetaxel every 3 weeks still remained superior to every-3-weeks paclitaxel in terms of DFS, with relative risk reductions of 16% and 21% for DFS events, respectively. However, trends favoring these two regimens in terms of OS didn’t reach statistical significance, reported Dr. Sparano, professor of medicine and women’s health at Albert Einstein College of Medicine, New York.
Among the more interesting findings to emerge from the extended analysis was the differential treatment response based upon breast cancer subtype. Among the 1,025 women with triple-negative breast cancer (TNBC), weekly paclitaxel was associated with highly significant relative risk reductions of 31% both for DFS events and mortality. This regimen boosted the 10-year DFS rate from 59% with every-3-weeks paclitaxel to 69%, while improving 10-year overall survival from 66% to 75%.
“Our findings also show that there remains substantial room for improvement in this population, despite the improvement seen with weekly paclitaxel,” the medical oncologist observed.
This is the rationale for the pending NRG-BR003 trial, in which patients with TNBC are randomized to four cycles of adjuvant chemotherapy followed by weekly paclitaxel for 12 weeks, as in the most effective arm of E1199, or to the same regimen supplemented by carboplatin in an effort to enhance outcomes.
In E1199, TNBC was associated with a very high annual risk of cancer recurrence within the first 3 years, which declined substantially thereafter. In contrast, for the 2,785 participants with hormone receptor (HR)-positive/HER2-negative breast cancer, the recurrence risk remained persistently strong beyond 5 years.
Obesity, which was present in 35% of all E1199 participants, was associated with worse outcomes in the HR-positive/HER2-negative group, where in a multivariate analysis it was independently associated with a 23% reduction in OS and a recurrence risk peaking 3-8 years after diagnosis.
“I think an important finding from this study is that obesity tends to be associated with later relapse. So if dietary and lifestyle and other metabolic-type interventions are going to be successful, there may be an adequate window to implement those changes and have a real impact on outcomes,” according to Dr. Sparano.
Black race was also independently associated with worse outcomes in HR-positive/HER2-negative patients but not in those with TNBC. In nonobese women with HER-positive/HER2-negative disease, black race was associated with roughly 2.3-fold increased risks of DFS events and mortality.
“These findings indicate an effect of race independent of obesity. That’s an important finding given the fact that obesity rates were twofold higher in patients of black race,” Dr. Sparano said.
In women with HR-positive/HER2-negative breast cancer, the only study regimen that proved more effective than paclitaxel every 3 weeks was docetaxel every 3 weeks, which in the extended follow-up resulted in a 24% reduction in the risk of DFS events but no significant advantage in OS.
“This suggests that attention to extended adjuvant endocrine therapy may be more relevant in this subpopulation, which is at risk for late relapse, particularly at the time of this study, when extended adjuvant therapy was not common practice,” he noted.
Late relapse remains “a vexing problem” in HR-positive/HER2-negative patients, Dr. Sparano continued. A major effort is underway to address this via an ECOG-ACRIN North American Breast Cancer Intergroup project designed to establish a late-relapse biospecimen bank featuring blood and/or tumor samples from 10,000 women enrolled in the TAILORx (Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer) and E5103 trials.
SAN ANTONIO – Extended follow-up of the nearly 5,000 women enrolled in the phase III multicenter E1199 trial has provided a wealth of new findings – and additional leads – regarding optimal adjuvant chemotherapy in patients with axillary lymph node–positive or high-risk, lymph node–negative breast cancer.
“The relative effectiveness of weekly paclitaxel and every-3-week docetaxel may vary by subtype,” Dr. Joseph A. Sparano reported at the San Antonio Breast Cancer Symposium.
The E1199 trial, conducted in 1999-2001, included 4,950 breast cancer patients who first received four cycles of standard adjuvant chemotherapy consisting of intravenous doxorubicin and cyclophosphamide at 3-week intervals. They were then assigned in a 2x2 factorial design to intravenous paclitaxel (Abraxane) at the then-standard 3-week intervals for four cycles, to weekly paclitaxel for 12 weeks, or to docetaxel (Taxotere) given at either of the same two dosing schedules.
The goal was to determine the optimally effective adjuvant taxane and dosing regimen. And in the initial report based upon a median 5.3 years of follow-up (N. Engl. J. Med. 2008;358:1663-71), weekly paclitaxel was the clear winner. It was associated with a 27% improvement in the likelihood of disease-free survival (DFS) and a 32% gain in overall survival (OS), compared with paclitaxel given every 3 weeks. Docetaxel every 3 weeks also resulted in improved DFS, but not in OS.
Dr. Sparano’s newly updated analysis was based upon a median 12.1 years of follow-up. By this point the number of DFS events – defined as recurrence, contralateral breast cancer, or death – had climbed to 1,639, compared with 1,058 in the initial report. The all-cause death count had risen from 686 to 1,283.
With the extended follow-up, both weekly paclitaxel and docetaxel every 3 weeks still remained superior to every-3-weeks paclitaxel in terms of DFS, with relative risk reductions of 16% and 21% for DFS events, respectively. However, trends favoring these two regimens in terms of OS didn’t reach statistical significance, reported Dr. Sparano, professor of medicine and women’s health at Albert Einstein College of Medicine, New York.
Among the more interesting findings to emerge from the extended analysis was the differential treatment response based upon breast cancer subtype. Among the 1,025 women with triple-negative breast cancer (TNBC), weekly paclitaxel was associated with highly significant relative risk reductions of 31% both for DFS events and mortality. This regimen boosted the 10-year DFS rate from 59% with every-3-weeks paclitaxel to 69%, while improving 10-year overall survival from 66% to 75%.
“Our findings also show that there remains substantial room for improvement in this population, despite the improvement seen with weekly paclitaxel,” the medical oncologist observed.
This is the rationale for the pending NRG-BR003 trial, in which patients with TNBC are randomized to four cycles of adjuvant chemotherapy followed by weekly paclitaxel for 12 weeks, as in the most effective arm of E1199, or to the same regimen supplemented by carboplatin in an effort to enhance outcomes.
In E1199, TNBC was associated with a very high annual risk of cancer recurrence within the first 3 years, which declined substantially thereafter. In contrast, for the 2,785 participants with hormone receptor (HR)-positive/HER2-negative breast cancer, the recurrence risk remained persistently strong beyond 5 years.
Obesity, which was present in 35% of all E1199 participants, was associated with worse outcomes in the HR-positive/HER2-negative group, where in a multivariate analysis it was independently associated with a 23% reduction in OS and a recurrence risk peaking 3-8 years after diagnosis.
“I think an important finding from this study is that obesity tends to be associated with later relapse. So if dietary and lifestyle and other metabolic-type interventions are going to be successful, there may be an adequate window to implement those changes and have a real impact on outcomes,” according to Dr. Sparano.
Black race was also independently associated with worse outcomes in HR-positive/HER2-negative patients but not in those with TNBC. In nonobese women with HER-positive/HER2-negative disease, black race was associated with roughly 2.3-fold increased risks of DFS events and mortality.
“These findings indicate an effect of race independent of obesity. That’s an important finding given the fact that obesity rates were twofold higher in patients of black race,” Dr. Sparano said.
In women with HR-positive/HER2-negative breast cancer, the only study regimen that proved more effective than paclitaxel every 3 weeks was docetaxel every 3 weeks, which in the extended follow-up resulted in a 24% reduction in the risk of DFS events but no significant advantage in OS.
“This suggests that attention to extended adjuvant endocrine therapy may be more relevant in this subpopulation, which is at risk for late relapse, particularly at the time of this study, when extended adjuvant therapy was not common practice,” he noted.
Late relapse remains “a vexing problem” in HR-positive/HER2-negative patients, Dr. Sparano continued. A major effort is underway to address this via an ECOG-ACRIN North American Breast Cancer Intergroup project designed to establish a late-relapse biospecimen bank featuring blood and/or tumor samples from 10,000 women enrolled in the TAILORx (Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer) and E5103 trials.
SAN ANTONIO – Extended follow-up of the nearly 5,000 women enrolled in the phase III multicenter E1199 trial has provided a wealth of new findings – and additional leads – regarding optimal adjuvant chemotherapy in patients with axillary lymph node–positive or high-risk, lymph node–negative breast cancer.
“The relative effectiveness of weekly paclitaxel and every-3-week docetaxel may vary by subtype,” Dr. Joseph A. Sparano reported at the San Antonio Breast Cancer Symposium.
The E1199 trial, conducted in 1999-2001, included 4,950 breast cancer patients who first received four cycles of standard adjuvant chemotherapy consisting of intravenous doxorubicin and cyclophosphamide at 3-week intervals. They were then assigned in a 2x2 factorial design to intravenous paclitaxel (Abraxane) at the then-standard 3-week intervals for four cycles, to weekly paclitaxel for 12 weeks, or to docetaxel (Taxotere) given at either of the same two dosing schedules.
The goal was to determine the optimally effective adjuvant taxane and dosing regimen. And in the initial report based upon a median 5.3 years of follow-up (N. Engl. J. Med. 2008;358:1663-71), weekly paclitaxel was the clear winner. It was associated with a 27% improvement in the likelihood of disease-free survival (DFS) and a 32% gain in overall survival (OS), compared with paclitaxel given every 3 weeks. Docetaxel every 3 weeks also resulted in improved DFS, but not in OS.
Dr. Sparano’s newly updated analysis was based upon a median 12.1 years of follow-up. By this point the number of DFS events – defined as recurrence, contralateral breast cancer, or death – had climbed to 1,639, compared with 1,058 in the initial report. The all-cause death count had risen from 686 to 1,283.
With the extended follow-up, both weekly paclitaxel and docetaxel every 3 weeks still remained superior to every-3-weeks paclitaxel in terms of DFS, with relative risk reductions of 16% and 21% for DFS events, respectively. However, trends favoring these two regimens in terms of OS didn’t reach statistical significance, reported Dr. Sparano, professor of medicine and women’s health at Albert Einstein College of Medicine, New York.
Among the more interesting findings to emerge from the extended analysis was the differential treatment response based upon breast cancer subtype. Among the 1,025 women with triple-negative breast cancer (TNBC), weekly paclitaxel was associated with highly significant relative risk reductions of 31% both for DFS events and mortality. This regimen boosted the 10-year DFS rate from 59% with every-3-weeks paclitaxel to 69%, while improving 10-year overall survival from 66% to 75%.
“Our findings also show that there remains substantial room for improvement in this population, despite the improvement seen with weekly paclitaxel,” the medical oncologist observed.
This is the rationale for the pending NRG-BR003 trial, in which patients with TNBC are randomized to four cycles of adjuvant chemotherapy followed by weekly paclitaxel for 12 weeks, as in the most effective arm of E1199, or to the same regimen supplemented by carboplatin in an effort to enhance outcomes.
In E1199, TNBC was associated with a very high annual risk of cancer recurrence within the first 3 years, which declined substantially thereafter. In contrast, for the 2,785 participants with hormone receptor (HR)-positive/HER2-negative breast cancer, the recurrence risk remained persistently strong beyond 5 years.
Obesity, which was present in 35% of all E1199 participants, was associated with worse outcomes in the HR-positive/HER2-negative group, where in a multivariate analysis it was independently associated with a 23% reduction in OS and a recurrence risk peaking 3-8 years after diagnosis.
“I think an important finding from this study is that obesity tends to be associated with later relapse. So if dietary and lifestyle and other metabolic-type interventions are going to be successful, there may be an adequate window to implement those changes and have a real impact on outcomes,” according to Dr. Sparano.
Black race was also independently associated with worse outcomes in HR-positive/HER2-negative patients but not in those with TNBC. In nonobese women with HER-positive/HER2-negative disease, black race was associated with roughly 2.3-fold increased risks of DFS events and mortality.
“These findings indicate an effect of race independent of obesity. That’s an important finding given the fact that obesity rates were twofold higher in patients of black race,” Dr. Sparano said.
In women with HR-positive/HER2-negative breast cancer, the only study regimen that proved more effective than paclitaxel every 3 weeks was docetaxel every 3 weeks, which in the extended follow-up resulted in a 24% reduction in the risk of DFS events but no significant advantage in OS.
“This suggests that attention to extended adjuvant endocrine therapy may be more relevant in this subpopulation, which is at risk for late relapse, particularly at the time of this study, when extended adjuvant therapy was not common practice,” he noted.
Late relapse remains “a vexing problem” in HR-positive/HER2-negative patients, Dr. Sparano continued. A major effort is underway to address this via an ECOG-ACRIN North American Breast Cancer Intergroup project designed to establish a late-relapse biospecimen bank featuring blood and/or tumor samples from 10,000 women enrolled in the TAILORx (Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer) and E5103 trials.
AT SABCS 2014
Key clinical point: The relative effectiveness of adjuvant taxane therapy given weekly or every 3 weeks appears to vary according to breast cancer subtype.
Major finding: At a median 12.1 years of follow-up, the most effective adjuvant taxane regimen for women with triple-negative breast cancer was weekly paclitaxel for 12 weeks.
Data source: The E1199 trial included 4,950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer who were randomized to adjuvant docetaxel or paclitaxel, given either weekly or every 3 weeks.
Disclosures: The E1199 trial was funded by the National Cancer Institute and the Breast Cancer Research Foundation. The presenter reported having no financial conflicts.
Aromatase inhibitors linked to dental problems
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.
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.
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.
AT SABCS 2014
Key clinical point: Breast cancer patients on adjuvant aromatase inhibitor therapy have previously unappreciated dental health issues.
Major finding: Women who had been on adjuvant aromatase inhibitor therapy for a median of 5.7 months when they completed standardized instruments measuring oral health–related quality of life reported significantly more problems in the domains of physical pain and disability as well as psychological discomfort, compared with controls.
Data source: An ongoing prospective cohort study involving 58 postmenopausal women.
Disclosures: The study is funded by the Michigan Institute for Clinical Health Research. The presenter reported having no relevant financial conflicts.
Breast cancer mortality down, but racial differences persist
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.
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.
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.
AT SABCS 2014
Key clinical point: Breast cancer mortality in patients under age 50 has declined in recent decades, but gains have been greater in white patients and the mortality gap between black and white women has not closed.
Major finding: During 2005-2009, the annual risk of breast cancer mortality in the first 3 years after diagnosis was 1.9% among young white patients compared with 4.5% in blacks.
Data source: A retrospective analysis of 162,976 women in the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry who were diagnosed with invasive breast cancer at age 18-49 during 1990-2009.
Disclosures: Dr. Ademuyiwa reported having no financial conflicts.
Adjuvant paclitaxel plus trastuzumab benefits patients with early breast cancer
Adjuvant therapy with trastuzumab plus paclitaxel yielded a 3-year recurrence rate of < 2% in an uncontrolled, nonrandomized study involving women who had small stage I HER2-positive breast cancers, according to a report published online Jan. 8 in the New England Journal of Medicine.
Currently no standard treatment is recommended for such patients, and clinicians must weigh the generally favorable outcomes for small, stage I tumors that aren’t targeted with adjuvant chemotherapy against the potential for considerable toxic effects from adjuvant chemotherapy. Clinical trials of trastuzumab have focused on patients with more advanced cancers. “Although patients with stage I HER2-positive tumors are expected to derive a smaller absolute benefit from adjuvant therapy than those with larger or node-positive tumors, they remain at more than minimal risk for a recurrence of breast cancer,” said Dr. Sara M. Tolaney of the department of medical oncology, Dana-Farber Cancer Institute, Boston, and her associates.
Their industry-sponsored single-group study involved 406 patients with a median age of 55 years (range, 24-85 years) whose breast adenocarcinomas measured no more than 3 cm. After undergoing surgical excisions, all the study participants were assigned to receive weekly IV paclitaxel and IV trastuzumab for 12 weeks, after which trastuzumab could be continued at the same weekly dose for 40 weeks or the regimen could be changed to a slightly higher dose every 3 weeks for 40 weeks.
A total of 356 patients (87.7%) completed the full year of adjuvant trastuzumab. Women who opted for partial- or whole-breast irradiation commenced that treatment after completing paclitaxel and while taking trastuzumab, and those who chose hormonal therapy also began taking those agents after completing paclitaxel and while taking trastuzumab. Median follow-up was 4 years (maximum, 6.2 years).
At 3-year follow-up, the rate of cancer-free survival was 98.7%, which was higher than would have been predicted by historical data; there were four distant and four local or regional metastases. According to the study’s statistical design, adjuvant trastuzumab would be considered successful if the 3-year recurrence rate were 5% or lower and there were 39 or fewer metastases, Dr. Tolaney and her associates said (N. Engl. J. Med. 2015 Jan. 8 [doi:10.1056/NEJM0a1406281]).
A total of 6% of patients withdrew from the study because of treatment-related adverse effects. The most important known adverse effect of trastuzumab is left ventricular dysfunction, so cardiac function was assessed at several intervals during the year of active therapy. Two patients (0.5%) developed grade 3 LV dysfunction during treatment, and both recovered after the drug was discontinued. Thirteen patients (3.2%) showed an asymptomatic decline in ejection fraction that led to an interruption in trastuzumab therapy; this normalized in 11 of them, who then resumed the treatment. Seven patients developed grade 3 or 4 allergic reactions, and only one of them was able to resume the treatment.
Adjuvant therapy with trastuzumab plus paclitaxel yielded a 3-year recurrence rate of < 2% in an uncontrolled, nonrandomized study involving women who had small stage I HER2-positive breast cancers, according to a report published online Jan. 8 in the New England Journal of Medicine.
Currently no standard treatment is recommended for such patients, and clinicians must weigh the generally favorable outcomes for small, stage I tumors that aren’t targeted with adjuvant chemotherapy against the potential for considerable toxic effects from adjuvant chemotherapy. Clinical trials of trastuzumab have focused on patients with more advanced cancers. “Although patients with stage I HER2-positive tumors are expected to derive a smaller absolute benefit from adjuvant therapy than those with larger or node-positive tumors, they remain at more than minimal risk for a recurrence of breast cancer,” said Dr. Sara M. Tolaney of the department of medical oncology, Dana-Farber Cancer Institute, Boston, and her associates.
Their industry-sponsored single-group study involved 406 patients with a median age of 55 years (range, 24-85 years) whose breast adenocarcinomas measured no more than 3 cm. After undergoing surgical excisions, all the study participants were assigned to receive weekly IV paclitaxel and IV trastuzumab for 12 weeks, after which trastuzumab could be continued at the same weekly dose for 40 weeks or the regimen could be changed to a slightly higher dose every 3 weeks for 40 weeks.
A total of 356 patients (87.7%) completed the full year of adjuvant trastuzumab. Women who opted for partial- or whole-breast irradiation commenced that treatment after completing paclitaxel and while taking trastuzumab, and those who chose hormonal therapy also began taking those agents after completing paclitaxel and while taking trastuzumab. Median follow-up was 4 years (maximum, 6.2 years).
At 3-year follow-up, the rate of cancer-free survival was 98.7%, which was higher than would have been predicted by historical data; there were four distant and four local or regional metastases. According to the study’s statistical design, adjuvant trastuzumab would be considered successful if the 3-year recurrence rate were 5% or lower and there were 39 or fewer metastases, Dr. Tolaney and her associates said (N. Engl. J. Med. 2015 Jan. 8 [doi:10.1056/NEJM0a1406281]).
A total of 6% of patients withdrew from the study because of treatment-related adverse effects. The most important known adverse effect of trastuzumab is left ventricular dysfunction, so cardiac function was assessed at several intervals during the year of active therapy. Two patients (0.5%) developed grade 3 LV dysfunction during treatment, and both recovered after the drug was discontinued. Thirteen patients (3.2%) showed an asymptomatic decline in ejection fraction that led to an interruption in trastuzumab therapy; this normalized in 11 of them, who then resumed the treatment. Seven patients developed grade 3 or 4 allergic reactions, and only one of them was able to resume the treatment.
Adjuvant therapy with trastuzumab plus paclitaxel yielded a 3-year recurrence rate of < 2% in an uncontrolled, nonrandomized study involving women who had small stage I HER2-positive breast cancers, according to a report published online Jan. 8 in the New England Journal of Medicine.
Currently no standard treatment is recommended for such patients, and clinicians must weigh the generally favorable outcomes for small, stage I tumors that aren’t targeted with adjuvant chemotherapy against the potential for considerable toxic effects from adjuvant chemotherapy. Clinical trials of trastuzumab have focused on patients with more advanced cancers. “Although patients with stage I HER2-positive tumors are expected to derive a smaller absolute benefit from adjuvant therapy than those with larger or node-positive tumors, they remain at more than minimal risk for a recurrence of breast cancer,” said Dr. Sara M. Tolaney of the department of medical oncology, Dana-Farber Cancer Institute, Boston, and her associates.
Their industry-sponsored single-group study involved 406 patients with a median age of 55 years (range, 24-85 years) whose breast adenocarcinomas measured no more than 3 cm. After undergoing surgical excisions, all the study participants were assigned to receive weekly IV paclitaxel and IV trastuzumab for 12 weeks, after which trastuzumab could be continued at the same weekly dose for 40 weeks or the regimen could be changed to a slightly higher dose every 3 weeks for 40 weeks.
A total of 356 patients (87.7%) completed the full year of adjuvant trastuzumab. Women who opted for partial- or whole-breast irradiation commenced that treatment after completing paclitaxel and while taking trastuzumab, and those who chose hormonal therapy also began taking those agents after completing paclitaxel and while taking trastuzumab. Median follow-up was 4 years (maximum, 6.2 years).
At 3-year follow-up, the rate of cancer-free survival was 98.7%, which was higher than would have been predicted by historical data; there were four distant and four local or regional metastases. According to the study’s statistical design, adjuvant trastuzumab would be considered successful if the 3-year recurrence rate were 5% or lower and there were 39 or fewer metastases, Dr. Tolaney and her associates said (N. Engl. J. Med. 2015 Jan. 8 [doi:10.1056/NEJM0a1406281]).
A total of 6% of patients withdrew from the study because of treatment-related adverse effects. The most important known adverse effect of trastuzumab is left ventricular dysfunction, so cardiac function was assessed at several intervals during the year of active therapy. Two patients (0.5%) developed grade 3 LV dysfunction during treatment, and both recovered after the drug was discontinued. Thirteen patients (3.2%) showed an asymptomatic decline in ejection fraction that led to an interruption in trastuzumab therapy; this normalized in 11 of them, who then resumed the treatment. Seven patients developed grade 3 or 4 allergic reactions, and only one of them was able to resume the treatment.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Adjuvant therapy with paclitaxel plus trastuzumab yielded a 3-year recurrence rate of < 2% in stage I HER2-positive breast cancer.
Major finding: At 3-year follow-up, the rate of cancer-free survival was 98.7%; there were four distant and four local or regional metastases.
Data source: An uncontrolled multicenter study involving 406 patients with small, node-negative tumors who all received adjuvant trastuzumab for up to 9 months and were followed for up to 7 years.
Disclosures: This study was funded by Genentech. Dr. Tolaney and her associates reported other ties to Genentech, and her associates reported ties to numerous industry sources.
International study characterizes male breast cancer
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.
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.
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.
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.
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.
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.
On Twitter @alz_gal
AT SABCS 2014
Key clinical point: Male breast cancers are similar to female cancers in terms of tumor characteristics and long-term outcomes.
Major finding: Male breast cancers were most often hormone receptor positive and of luminal A subtype, and responded less favorably if estrogen and progesterone receptor negative.
Data source: A retrospective cohort study of about 1,800 patients.
Disclosures: The authors had no financial disclosures.