Hope S Rugo1, R Bryan Rumble1, Erin Macrae1, Debra L Barton1, Hannah Klein Connolly1, Maura N Dickler1, Lesley Fallowfield1, Barbara Fowble1, James N Ingle1, Mohammad Jahanzeb1, Stephen R D Johnston1, Larissa A Korde1, James L Khatcheressian1, Rita S Mehta1, Hyman B Muss1, Harold J Burstein1. 1. Hope S. Rugo, University of California San Francisco Comprehensive Cancer Center; Barbara Fowble, University of California San Francisco, San Francisco; Rita S. Mehta, University of California Irvine, Orange, CA; R. Bryan Rumble, American Society of Clinical Oncology, Alexandria; James L. Khatcheressian, Virginia Cancer Institute, Richmond, VA; Erin Macrae, Columbus Oncology and Hematology Associates, Columbus, OH; Debra L. Barton, University of Michigan School of Nursing, Ann Arbor, MI; Hannah Klein Connolly, Patient Representative, Edina, MN; Maura N. Dickler, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Lesley Fallowfield, Sussex Health Outcomes Research and Education in Cancer, Brighton and Sussex Medical School, University of Sussex, Sussex; Stephen R.D. Johnston, Royal Marsden Hospital, London, United Kingdom; James N. Ingle, Mayo Clinic, Rochester, MN; Mohammad Jahanzeb, University of Miami Sylvester Comprehensive Cancer Center, Deerfield Beach, FL; Larissa A. Korde, University of Washington, Seattle, WA; Hyman B. Muss, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; and Harold J. Burstein, Dana-Farber Cancer Center, Boston, MA.
Abstract
PURPOSE: To develop recommendations about endocrine therapy for women with hormone receptor (HR) -positive metastatic breast cancer (MBC). METHODS: The American Society of Clinical Oncology convened an Expert Panel to conduct a systematic review of evidence from 2008 through 2015 to create recommendations informed by that evidence. Outcomes of interest included sequencing of hormonal agents, hormonal agents compared with chemotherapy, targeted biologic therapy, and treatment of premenopausal women. This guideline puts forth recommendations for endocrine therapy as treatment for women with HR-positive MBC. RECOMMENDATIONS: Sequential hormone therapy is the preferential treatment for most women with HR-positive MBC. Except in cases of immediately life-threatening disease, hormone therapy, alone or in combination, should be used as initial treatment. Patients whose tumors express any level of hormone receptors should be offered hormone therapy. Treatment recommendations should be based on type of adjuvant treatment, disease-free interval, and organ function. Tumor markers should not be the sole criteria for determining tumor progression; use of additional biomarkers remains experimental. Assessment of menopausal status is critical; ovarian suppression or ablation should be included in premenopausal women. For postmenopausal women, aromatase inhibitors (AIs) are the preferred first-line endocrine therapy, with or without the cyclin-dependent kinase inhibitor palbociclib. As second-line therapy, fulvestrant should be administered at 500 mg with a loading schedule and may be administered with palbociclib. The mammalian target of rapamycin inhibitor everolimus may be administered with exemestane to postmenopausal women with MBC whose disease progresses while receiving nonsteroidal AIs. Among patients with HR-positive, human epidermal growth factor receptor 2-positive MBC, human epidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates.
PURPOSE: To develop recommendations about endocrine therapy for women with hormone receptor (HR) -positive metastatic breast cancer (MBC). METHODS: The American Society of Clinical Oncology convened an Expert Panel to conduct a systematic review of evidence from 2008 through 2015 to create recommendations informed by that evidence. Outcomes of interest included sequencing of hormonal agents, hormonal agents compared with chemotherapy, targeted biologic therapy, and treatment of premenopausal women. This guideline puts forth recommendations for endocrine therapy as treatment for women with HR-positive MBC. RECOMMENDATIONS: Sequential hormone therapy is the preferential treatment for most women with HR-positive MBC. Except in cases of immediately life-threatening disease, hormone therapy, alone or in combination, should be used as initial treatment. Patients whose tumors express any level of hormone receptors should be offered hormone therapy. Treatment recommendations should be based on type of adjuvant treatment, disease-free interval, and organ function. Tumor markers should not be the sole criteria for determining tumor progression; use of additional biomarkers remains experimental. Assessment of menopausal status is critical; ovarian suppression or ablation should be included in premenopausal women. For postmenopausal women, aromatase inhibitors (AIs) are the preferred first-line endocrine therapy, with or without the cyclin-dependent kinase inhibitor palbociclib. As second-line therapy, fulvestrant should be administered at 500 mg with a loading schedule and may be administered with palbociclib. The mammalian target of rapamycin inhibitor everolimus may be administered with exemestane to postmenopausal women with MBC whose disease progresses while receiving nonsteroidal AIs. Among patients with HR-positive, humanepidermal growth factor receptor 2-positive MBC, humanepidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates.
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