High-Dose Fulvestrant for Advanced Breast Cancer

A modest improvement in survival without an increase in toxicity is confirmed.

The prior phase III, randomized CONFIRM trial compared the previously approved dose of fulvestrant (250 mg every 28 days) versus a higher dose (500 mg every 28 days plus an additional 500 mg on day 14 of the first month) in postmenopausal women with locally advanced or metastatic estrogen-receptor–positive breast cancer that recurred or progressed after endocrine therapy (NEJM Journal Watch Oncol Hematol Nov 9 2010). The initial analysis showed that higher-dose fulvestrant significantly improved progression-free survival (PFS) without increasing toxicity. Based on those results, 500 mg is now the approved dose of fulvestrant in the U.S., Japan, and Europe.

Now, the CONFIRM investigators have completed a final analysis of survival that was pr…

Reviewing Author

William J. Gradishar, MD

Disclosures

Consultant/Advisory BoardLilly; AstraZeneca; Gilead

Grant/Research SupportBreast Cancer Research Foundation

Editorial BoardsClinical Breast Cancer; Oncology; Annals of Surgery; Breast Cancer Research and Treatment

Leadership Positions in Professional SocietiesNational Comprehensive Cancer Network (Chair, Breast Cancer Panel); American Board of Internal Medicine (Medical Oncology Board)