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VIDEO: Good responses with antibody-drug conjugate in third-line metastatic TNBC therapy
SAN ANTONIO – Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.
Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.
In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.
The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.
Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.
In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.
The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.
Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.
In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.
The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
VIDEO: Dr. Sherene Loi discusses PANACEA trial and implications for pembrolizumab use
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
VIDEO: Meta-analysis lead author Dr. Richard Gray on dose intensity benefit
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
No benefit to trastuzumab in low HER2 breast cancer
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
REPORTING FROM SABCS 2017
Key clinical point: In contrast to earlier reports, trastuzumab does not improve outcomes in breast cancer patients with low HER2 levels.
Major finding: The 5-year invasive disease–free survival was 89.6% for those who received trastuzumab, compared with 89.2% for those who did not (HR 0.98 95% CI 0.77-1.26, P = .90).
Data source: Phase 3 randomized, prospective clinical trial of 3,720 heavily pretreated breast cancer patients with low HER2 levels.
Disclosures: The National Cancer Institute and Genentech supported the study. Dr. Fehrenbacher declared no conflicts of interest.
Source: Fehrenbacher et al. GS1-02.
SABCS 2017: Top picks from Dr. William J. Gradishar
Oncology Practice Associate Editor William J. Gradishar, MD, reveals several anticipated studies from the 40th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 6:
• GS1-01. Increasing the dose density of adjuvant chemotherapy by shortening intervals between courses or by sequential drug administration significantly reduces both disease recurrence and breast cancer mortality: an EBCTCG meta-analysis of 21,000 women in 16 randomized trials.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS1-03. Perioperative aromatase inhibitor treatment in determining or predicting long-term outcome in early breast cancer–the POETIC Trial.
• GS1-06. Extended adjuvant bisphosphonate treatment over 5 years in early breast cancer does not improve disease-free and overall survival, compared with 2 years of treatment: Phase III data from the SUCCESS A study.
• GS2-05. First-line ribociclib vs. placebo with goserelin and tamoxifen or a nonsteroidal aromatase inhibitor in premenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer: Results from the randomized phase III MONALEESA-7 trial.
• GS2-06. Phase Ib/II study evaluating safety and efficacy of pembrolizumab and trastuzumab in patients with trastuzumab-resistant HER2-positive metastatic breast cancer: Results from the PANACEA (IBCSG 45-13/KEYNOTE-014) study.
• GS2-07. MANTA – A randomized phase 2 study of fulvestrant in combination with the dual mTOR inhibitor AZD2014 or everolimus or fulvestrant alone in estrogen receptor–positive advanced or metastatic breast cancer.
• GS3-01. A prospective, randomized, multicenter phase 3 trial of additional 2 versus additional 5 years of anastrozole after initial 5 years of adjuvant endocrine therapy – results from 3,484 postmenopausal women in the ABCSG-16 trial.
• GS3-02. Invasive disease-free survival and gene-expression signatures in CALGB (Alliance) 40601, a randomized phase III neoadjuvant trial of dual HER2 targeting with lapatinib added to chemotherapy plus trastuzumab.
• GS3-03. A phase III, multicenter, double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients (REACT – Randomized European Celecoxib Trial).
• GS3-04. A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study).
• GS3-06. Long-term follow-up of CALGB 40502/NCCTG N063H (Alliance): A randomized phase III trial of weekly paclitaxel, compared with weekly nanoparticle albumin-bound (nab)–paclitaxel or ixabepilone +/– bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer.
• GS3-08. Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIAL.
• GS4-01. Pooled analysis of five randomized trials investigating temporary ovarian suppression with gonadotropin-releasing hormone analogues during chemotherapy as a strategy to preserve ovarian function and fertility in premenopausal early breast cancer patients.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS4-03. Randomized comparison of adjuvant tamoxifen plus ovarian function suppression versus tamoxifen in premenopausal women with hormone receptor–positive early breast cancer: Update of the SOFT trial.
• GS4-04. Randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in women with early-stage breast cancer.
• GS5-03. Risk of arm morbidity after local therapy in young breast cancer survivors.
• GS5-05. Primary endocrine therapy for ER-positive ductal carcinoma in situ: CALGB 40903 (Alliance).
• GS6-01. Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor–positive breast cancer treated with 5 years of endocrine therapy.
• GS6-02. The benefit of abemaciclib in prognostic subgroups: An exploratory analysis of combined data from the MONARCH 2 and 3 studies.
• GS6-07. EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA mutation.
Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and interim chief of the division of hematology/oncology, Northwestern University Feinberg School of Medicine, Chicago, and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
Oncology Practice Associate Editor William J. Gradishar, MD, reveals several anticipated studies from the 40th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 6:
• GS1-01. Increasing the dose density of adjuvant chemotherapy by shortening intervals between courses or by sequential drug administration significantly reduces both disease recurrence and breast cancer mortality: an EBCTCG meta-analysis of 21,000 women in 16 randomized trials.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS1-03. Perioperative aromatase inhibitor treatment in determining or predicting long-term outcome in early breast cancer–the POETIC Trial.
• GS1-06. Extended adjuvant bisphosphonate treatment over 5 years in early breast cancer does not improve disease-free and overall survival, compared with 2 years of treatment: Phase III data from the SUCCESS A study.
• GS2-05. First-line ribociclib vs. placebo with goserelin and tamoxifen or a nonsteroidal aromatase inhibitor in premenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer: Results from the randomized phase III MONALEESA-7 trial.
• GS2-06. Phase Ib/II study evaluating safety and efficacy of pembrolizumab and trastuzumab in patients with trastuzumab-resistant HER2-positive metastatic breast cancer: Results from the PANACEA (IBCSG 45-13/KEYNOTE-014) study.
• GS2-07. MANTA – A randomized phase 2 study of fulvestrant in combination with the dual mTOR inhibitor AZD2014 or everolimus or fulvestrant alone in estrogen receptor–positive advanced or metastatic breast cancer.
• GS3-01. A prospective, randomized, multicenter phase 3 trial of additional 2 versus additional 5 years of anastrozole after initial 5 years of adjuvant endocrine therapy – results from 3,484 postmenopausal women in the ABCSG-16 trial.
• GS3-02. Invasive disease-free survival and gene-expression signatures in CALGB (Alliance) 40601, a randomized phase III neoadjuvant trial of dual HER2 targeting with lapatinib added to chemotherapy plus trastuzumab.
• GS3-03. A phase III, multicenter, double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients (REACT – Randomized European Celecoxib Trial).
• GS3-04. A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study).
• GS3-06. Long-term follow-up of CALGB 40502/NCCTG N063H (Alliance): A randomized phase III trial of weekly paclitaxel, compared with weekly nanoparticle albumin-bound (nab)–paclitaxel or ixabepilone +/– bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer.
• GS3-08. Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIAL.
• GS4-01. Pooled analysis of five randomized trials investigating temporary ovarian suppression with gonadotropin-releasing hormone analogues during chemotherapy as a strategy to preserve ovarian function and fertility in premenopausal early breast cancer patients.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS4-03. Randomized comparison of adjuvant tamoxifen plus ovarian function suppression versus tamoxifen in premenopausal women with hormone receptor–positive early breast cancer: Update of the SOFT trial.
• GS4-04. Randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in women with early-stage breast cancer.
• GS5-03. Risk of arm morbidity after local therapy in young breast cancer survivors.
• GS5-05. Primary endocrine therapy for ER-positive ductal carcinoma in situ: CALGB 40903 (Alliance).
• GS6-01. Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor–positive breast cancer treated with 5 years of endocrine therapy.
• GS6-02. The benefit of abemaciclib in prognostic subgroups: An exploratory analysis of combined data from the MONARCH 2 and 3 studies.
• GS6-07. EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA mutation.
Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and interim chief of the division of hematology/oncology, Northwestern University Feinberg School of Medicine, Chicago, and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
Oncology Practice Associate Editor William J. Gradishar, MD, reveals several anticipated studies from the 40th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 6:
• GS1-01. Increasing the dose density of adjuvant chemotherapy by shortening intervals between courses or by sequential drug administration significantly reduces both disease recurrence and breast cancer mortality: an EBCTCG meta-analysis of 21,000 women in 16 randomized trials.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS1-03. Perioperative aromatase inhibitor treatment in determining or predicting long-term outcome in early breast cancer–the POETIC Trial.
• GS1-06. Extended adjuvant bisphosphonate treatment over 5 years in early breast cancer does not improve disease-free and overall survival, compared with 2 years of treatment: Phase III data from the SUCCESS A study.
• GS2-05. First-line ribociclib vs. placebo with goserelin and tamoxifen or a nonsteroidal aromatase inhibitor in premenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer: Results from the randomized phase III MONALEESA-7 trial.
• GS2-06. Phase Ib/II study evaluating safety and efficacy of pembrolizumab and trastuzumab in patients with trastuzumab-resistant HER2-positive metastatic breast cancer: Results from the PANACEA (IBCSG 45-13/KEYNOTE-014) study.
• GS2-07. MANTA – A randomized phase 2 study of fulvestrant in combination with the dual mTOR inhibitor AZD2014 or everolimus or fulvestrant alone in estrogen receptor–positive advanced or metastatic breast cancer.
• GS3-01. A prospective, randomized, multicenter phase 3 trial of additional 2 versus additional 5 years of anastrozole after initial 5 years of adjuvant endocrine therapy – results from 3,484 postmenopausal women in the ABCSG-16 trial.
• GS3-02. Invasive disease-free survival and gene-expression signatures in CALGB (Alliance) 40601, a randomized phase III neoadjuvant trial of dual HER2 targeting with lapatinib added to chemotherapy plus trastuzumab.
• GS3-03. A phase III, multicenter, double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients (REACT – Randomized European Celecoxib Trial).
• GS3-04. A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study).
• GS3-06. Long-term follow-up of CALGB 40502/NCCTG N063H (Alliance): A randomized phase III trial of weekly paclitaxel, compared with weekly nanoparticle albumin-bound (nab)–paclitaxel or ixabepilone +/– bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer.
• GS3-08. Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIAL.
• GS4-01. Pooled analysis of five randomized trials investigating temporary ovarian suppression with gonadotropin-releasing hormone analogues during chemotherapy as a strategy to preserve ovarian function and fertility in premenopausal early breast cancer patients.
• GS4-02. Randomized comparison of adjuvant aromatase inhibitor exemestane plus ovarian function suppression vs. tamoxifen plus OFS in premenopausal women with hormone receptor–positive early breast cancer: Update of the combined TEXT and SOFT trials.
• GS4-03. Randomized comparison of adjuvant tamoxifen plus ovarian function suppression versus tamoxifen in premenopausal women with hormone receptor–positive early breast cancer: Update of the SOFT trial.
• GS4-04. Randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in women with early-stage breast cancer.
• GS5-03. Risk of arm morbidity after local therapy in young breast cancer survivors.
• GS5-05. Primary endocrine therapy for ER-positive ductal carcinoma in situ: CALGB 40903 (Alliance).
• GS6-01. Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor–positive breast cancer treated with 5 years of endocrine therapy.
• GS6-02. The benefit of abemaciclib in prognostic subgroups: An exploratory analysis of combined data from the MONARCH 2 and 3 studies.
• GS6-07. EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA mutation.
Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and interim chief of the division of hematology/oncology, Northwestern University Feinberg School of Medicine, Chicago, and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
FROM SABCS 2017
SABCS opening plenary to address potential of RT to transform tumors into vaccines
Silvia Formenti, MD, will open the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) with a plenary talk on the potential for radiotherapy (RT) to convert irradiated metastatic breast tumors into individualized, in situ vaccines.
“DNA damage response contributes to immune rejection of tumors, a mechanism at least in part responsible for the success of platinum and RT combinations. RT-induced cell death can evoke T-cell memory, inducing effects outside the irradiated field, defined as abscopal. In the setting of metastatic cancer, however, the occurrence of abscopal effects is extremely rare because of the established immune-suppressive microenvironment. Thus, the proimmunogenic effect of radiotherapy is best exploited in combination with immunotherapy, and the combination of RT and immune checkpoint blockade has matured to reach clinical translation,” Dr. Formenti, of Weill Cornell Medicine, New York, wrote in the abstract.
Dr. Formenti and her colleagues have translated preclinical work into clinical trials in metastatic breast cancer, as well as other tumors. Her presentation will focus on the mechanisms and on the ongoing work to determine the appropriate RT dose and fractionation to achieve abscopal responses.
Dr. Formenti will present the opening plenary on Wednesday Dec. 6 at 9 a.m. in Hall 3 of the Henry B. Gonzalez Convention Center in San Antonio.
The rest of the SABCS schedule and abstracts to be presented are available here. The symposium is sponsored by the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine in Houston.
Silvia Formenti, MD, will open the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) with a plenary talk on the potential for radiotherapy (RT) to convert irradiated metastatic breast tumors into individualized, in situ vaccines.
“DNA damage response contributes to immune rejection of tumors, a mechanism at least in part responsible for the success of platinum and RT combinations. RT-induced cell death can evoke T-cell memory, inducing effects outside the irradiated field, defined as abscopal. In the setting of metastatic cancer, however, the occurrence of abscopal effects is extremely rare because of the established immune-suppressive microenvironment. Thus, the proimmunogenic effect of radiotherapy is best exploited in combination with immunotherapy, and the combination of RT and immune checkpoint blockade has matured to reach clinical translation,” Dr. Formenti, of Weill Cornell Medicine, New York, wrote in the abstract.
Dr. Formenti and her colleagues have translated preclinical work into clinical trials in metastatic breast cancer, as well as other tumors. Her presentation will focus on the mechanisms and on the ongoing work to determine the appropriate RT dose and fractionation to achieve abscopal responses.
Dr. Formenti will present the opening plenary on Wednesday Dec. 6 at 9 a.m. in Hall 3 of the Henry B. Gonzalez Convention Center in San Antonio.
The rest of the SABCS schedule and abstracts to be presented are available here. The symposium is sponsored by the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine in Houston.
Silvia Formenti, MD, will open the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) with a plenary talk on the potential for radiotherapy (RT) to convert irradiated metastatic breast tumors into individualized, in situ vaccines.
“DNA damage response contributes to immune rejection of tumors, a mechanism at least in part responsible for the success of platinum and RT combinations. RT-induced cell death can evoke T-cell memory, inducing effects outside the irradiated field, defined as abscopal. In the setting of metastatic cancer, however, the occurrence of abscopal effects is extremely rare because of the established immune-suppressive microenvironment. Thus, the proimmunogenic effect of radiotherapy is best exploited in combination with immunotherapy, and the combination of RT and immune checkpoint blockade has matured to reach clinical translation,” Dr. Formenti, of Weill Cornell Medicine, New York, wrote in the abstract.
Dr. Formenti and her colleagues have translated preclinical work into clinical trials in metastatic breast cancer, as well as other tumors. Her presentation will focus on the mechanisms and on the ongoing work to determine the appropriate RT dose and fractionation to achieve abscopal responses.
Dr. Formenti will present the opening plenary on Wednesday Dec. 6 at 9 a.m. in Hall 3 of the Henry B. Gonzalez Convention Center in San Antonio.
The rest of the SABCS schedule and abstracts to be presented are available here. The symposium is sponsored by the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine in Houston.