Dr. Hortobagyi Discusses the BOLERO-2 Everolimus Trial

Gabriel N. Hortobagyi, MD, professor of medicine, chair, Department of Breast Medical Oncology, director, Multidisciplinary Breast Cancer Research Program, University of Texas MD Anderson Cancer Center, discusses the BOLERO-2 trial that examined everolimus (Afinitor) plus exemestane (Aromasin) in hormone receptor-positive (HR+) breast cancer.

The trial was a prospective, double blind, placebo-controlled, phase III trial examining 724 postmenopausal women with HR+ metastatic breast cancer that had previously been treated with an aromatase inhibitor such as anastrozole or letrozole. Patients were randomized 2:1 to receive exemestane plus everolimus or exemestane plus placebo.

At the median follow-up of 12.5 months the progression-free survival (PFS) was 7.4 months for the everolimus arm and 3.2 in the control arm. The hazard ratio was 0.44 with a highly significant P-value. At this point it is too early to determine an overall-survival benefit.

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