Dr. Garcia on Combination Therapy for Breast Cancer

Agustin A. Garcia, MD, Associate Professor of Medicine, Keck School of Medicine of the University of Southern California, discusses three clinical trials that examined the efficacy of combining therapeutics for the treatment of patients with hormone receptor positive advanced breast cancer.

Garcia explains that results from the BOLERO-2 trial have shown a significant benefit for the combination of everolimus and exemestane. The phase III BOLERO-2 trial enrolled 724 postmenopausal women with estrogen receptor (ER)-positive, unresectable, locally advanced or metastatic breast cancer. The primary endpoint for this trial was progression-free survival (PFS), by local assessment, with several secondary endpoints, including overall survival (OS). The impressive results from this trial led to the FDA approval of the combination, Garcia notes.

Other combinations are showing promising results, although they have not yet been FDA approved, Garcia adds. The phase III randomized SWOG-S0226 trial compared anastrozole plus fulvestrant to anastrozole alone as a first-line therapy for postmenopausal ER or PgR-positive women with metastatic breast cancer. A significant improvement in both PFS and OS was observed; however, conflicting results were demonstrated in the European FACT trial that showed that single agent anastrozole was superior.

Further combination trials with the agent everolimus continue to stress the efficacy of combining therapies for breast cancer. A phase II randomized trial investigated tamoxifen plus everolimus in postmenopausal women with ER-positive breast cancer. This trial demonstrated promising results by prolonging both time to progression and overall survival.