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Accreditation/ Credit Designation

Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

These activites are not approved for AMA PRA Category 1 Credit™.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Astellas; AstraZeneca; Celgene Corporation; Eisai; Genentech; Genomic Health, Inc; Lilly; Medivation, Inc; Merck Sharp & Dohme Corp; and Novartis Pharmaceuticals Corporation.

For further information concerning Lilly grant funding visit www.lillygrantoffice.com.


14th Annual School of Breast Oncology® Online PER Pulse™ Recap

PER Pulse Recap

PER Pulse™ Recap


The School of Breast Oncology® provides oncologists with a curriculum-based program focused exclusively on the clinical management of breast cancer, with a comprehensive review of data on the most important aspects of breast cancer biology, diagnostics, prevention, and treatment (including surgery, radiation therapy, and systemic therapy). The 14th Annual School of Breast Oncology® was held November 3-5, 2016, in Atlanta, Georgia, and featured internationally recognized experts in breast cancer who discussed best practices and key advances for the treatment of patients across all stages of the disease. This first of 3 PER Pulse Recaps from the School of Breast Oncology® focuses on the treatment of hormone receptor (HR)-positive breast cancer, as presented by William J. Gradishar, MD, FASCO, FACP; Joyce O’Shaughnessy, MD; and Ruth O’Regan, MD.

Dr. Gradishar reviewed treatment considerations for the adjuvant treatment of postmenopausal patients with early stage breast cancer, highlighting the duration of endocrine therapy. A growing body of evidence, including data from the ATLAS and aTTom trials of tamoxifen, suggests that some patients benefit from a longer duration of adjuvant endocrine therapy. Results from the MA.17R trial, which compared 5 years versus 10 years of adjuvant therapy with an aromatase inhibitor (AI), were published in July 2016. Although extended therapy with an AI significantly reduced the risk of disease recurrence or contralateral breast cancer, this was at the expense of significant increases in new-onset osteoporosis and in fracture rates. Dr. Gradishar also reviewed available genomic assays that may help predict the long-term risk of recurrence in individual patients.

Dr. O’Shaughnessy discussed the integration of results from recent trials investigating the optimal management of premenopausal patients with HR-positive early stage breast cancers. Five years of tamoxifen (with or without ovarian suppression) has long been the mainstay of treatment for these patients. However, results from the SOFT and TEXT trials showed a significant improvement in breast cancer-free survival and distant recurrence-free survival with the combination of exemestane plus ovarian suppression compared with tamoxifen alone in premenopausal patients who previously received adjuvant chemotherapy, particularly in those younger than 35 years of age. In addition, data from the POEMS trial suggest that inclusion of a luteinizing hormone-releasing hormone agonist during adjuvant chemotherapy can help to preserve ovarian function and improve survival outcomes for premenopausal women with breast cancer.

Targeted therapies are revolutionizing the treatment of HR-positive/HER2-negative metastatic breast cancer. Everolimus, the mTOR inhibitor, in combination with exemestane has been approved for several years. More recently, the CDK4/6 inhibitor palbociclib was approved by the FDA in combination with letrozole as a first-line endocrine therapy and in combination with fulvestrant as an option for AI-pretreated patients. Dr. O’Regan summarized evidence from the PALOMA-1 through PALOMA-3 trials supporting these approvals, as well as new data from the phase III MONALEESA-2 trial that compared first-line therapy with letrozole with or without ribociclib and showed a significant progression-free survival (PFS) benefit with the addition of the CDK4/6 inhibitor. In addition, she reviewed new data from the phase III FALCON trial, which showed a significant improvement in PFS with fulvestrant monotherapy compared with anastrozole in the first-line setting, particularly for patients without visceral disease.

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2 of 3
PER Pulse™ Recap

The School of Breast Oncology® provides oncologists with a curriculum-based program focused exclusively on the clinical management of breast cancer, with a comprehensive review of data on the most important aspects of breast cancer biology, diagnostics, prevention, and treatment (including surgery, radiation therapy, and systemic therapy). The 14th Annual School of Breast Oncology® was held November 3-5, 2016, in Atlanta, Georgia, and featured internationally recognized experts in breast cancer who discussed best practices and key advances for the treatment of patients across all stages of the disease. This second of 3 PER Pulse Recaps from the School of Breast Oncology® focuses on the treatment of HER2-positive breast cancer, as presented by William J. Gradishar, MD, FASCO, FACP, and Edward Romond, MD.

Dr. Gradishar reviewed current treatment algorithms for HER2+ metastatic breast cancer. Pertuzumab plus trastuzumab and a taxane has become the preferred first-line therapy, while trastuzumab emtansine (T-DM1) has become the preferred second-line option, based on results from the CLEOPATRA and EMILIA trials, respectively, both of which showed an overall survival benefit. Later-line options include trastuzumab/chemotherapy options and lapatinib alone or in combination with either capecitabine or trastuzumab. In addition, he discussed considerations with regard to HER2 testing, including ASCO/CAP guidelines, and the challenge of interpreting equivocal or ambiguous results.

Dr. Romond summarized data from the pivotal trials that led to the inclusion of trastuzumab in adjuvant treatment regimens for HER2+ early stage breast cancers and discussed considerations such as the optimal duration of HER2-targeted therapy, individualization of therapy for patients with cardiac risk factors, and options for patients with small, node-negative HER2+ cancers. In addition, he reviewed data from trials investigating the incorporation of HER2-targeted agents in preoperative regimens, as well as results from the phase III ExteNET trial that showed a significant improvement in invasive disease-free survival when adjuvant treatment was extended for 1 year with neratinib, the HER2-targeted tyrosine kinase inhibitor. Neratinib is not yet approved, but an FDA submission is under review.

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3 of 3
PER Pulse™ Recap

The School of Breast Oncology® provides oncologists with a curriculum-based program focused exclusively on the clinical management of breast cancer, with a comprehensive review of data on the most important aspects of breast cancer biology, diagnostics, prevention, and treatment (including surgery, radiation therapy, and systemic therapy). The 14th Annual School of Breast Oncology® was held November 3-5, 2016, in Atlanta, Georgia, and featured internationally recognized experts in breast cancer who discussed best practices and key advances for the treatment of patients across all stages of the disease. This third of 3 PER Pulse Recaps from the School of Breast Oncology® focuses on the treatment of triple negative breast cancer (TNBC), as presented by Joseph Sparano, MD, and Anne Moore, MD.

Dr. Moore reviewed treatment options for TNBC and endocrine-resistant ER+ metastatic breast cancer. Cytotoxic chemotherapy remains the only standard option for these patients, outside of clinical trials. She emphasized the importance of rebiopsying metastatic lesions in patients who originally present with early stage disease and later develop metastases, because biomarkers (estrogen, progesterone, and HER2 receptors) may change over time and affect treatment. In addition, Dr. Moore addressed other clinical considerations, such as selecting between sequential single agents versus combination treatment, determining duration of therapy, and managing patients with isolated resectable metastases.

TNBC is perceived to be the most challenging of the breast cancer subtypes to treat, due to the lack of validated molecular targets and proven targeted therapies, and Dr. Sparano discussed a number of investigational therapies. One of the keys to understanding TNBC is recognizing that this classification itself encompasses at least 6 molecular subtypes, each with a distinct biology and potential molecular targets. Poly (ADP-ribose) polymerase (PARP) inhibitors remain an active area of investigation, specifically in BRCA-mutated TNBCs, and phase III trials are ongoing with olaparib, rucaparib, veliparib, niraparib, and talazoparib. For patients with TNBC that overexpresses the androgen receptor, preliminary clinical activity has been observed in some patients with the androgen receptor antagonists bicalutamide and enzalutamide, and further studies are ongoing. Dr. Sparano also talked about several antibody-drug conjugates that are in late-stage development for TNBC, including the Trop2-directed sacituzumab govitecan (IMMU-132) and the GPNMB-directed glembatumumab vedotin (CDX-011). Finally, the anti-PD1/PD-L1 immune checkpoint inhibitors have perhaps generated the most attention; durable responses have been observed with pembrolizumab, atezolizumab, and avelumab, and several phase III trials are now underway.

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