Richard Pazdur, MD, of the U.S. Food & Drug Administration’s Oncology Center of Excellence, discusses the rapid changes in evaluating and approving new and effective agents, incorporating the view of patients in the process, and modernizing clinical trial design with broader eligibility criteria.
Louis Fehrenbacher, MD, of Kaiser Permanente, discusses study findings comparing adjuvant chemotherapy with doxorubicin and cyclophosphamide followed by weekly paclitaxel—or docetaxel and cyclophosphamide—with or without a year of trastuzumab in women with node-positive or high-risk node-negative disease (Abstract GS1-02).
Lynn J. Howie, MD, of the U. S. Food & Drug Administration, discusses a pooled analysis of outcomes of older women with hormone receptor–positive metastatic breast cancer treated with a CDK4/6 inhibitor as initial endocrine-based therapy (Abstract GS5-06).
Eric S. Winer, MD, of the Dana-Farber Cancer Institute, addresses the much-discussed controversy over whether all women diagnosed with metastatic breast cancer should undergo next-generation sequencing.
Lee S. Schwartzberg, MD, of the West Cancer Center, discusses phase II study findings evaluating exemestane with or without enzalutamide in patients with hormone receptor–positive breast cancer (Abstract GS4-07).
Michael Gnant, MD, of the Medical University of Vienna, discusses phase III study findings on giving an additional 2 vs an additional 5 years of anastrozole after the first 5 years of adjuvant endocrine therapy (Abstract GS3-01).
