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Everolimus plus exemestane extended PFS in invasive lobular carcinoma

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SAN FRANCISCO — The addition of everolimus to exemestane significantly prolonged PFS in a subset of patients with HR-positive, HER-2–negative advanced breast cancer who had invasive lobular carcinoma at baseline, according to a subanalysis of the BOLERO-2 trial presented at the Breast Cancer Symposium.

Gabriel N. Hortobagyi, MD, FACP, professor of medicine in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center, and colleagues evaluated data from 104 patients with invasive lobular carcinoma. The cohort included patients with predominantly peritoneal, gastrointestinal and ovarian metastases.

Gabriel N. Hortobagyi

Patients received exemestane (Aromasin, Pfizer) with everolimus (Afinitor, Novartis; n=64) or placebo (n=40).

The median age of the patients was 63 years, and 47.1% had measurable disease. Thirty-six percent of patients had visceral metastases of the lung, liver, pleural and peritoneum; 10% had lung metastases; and 23% had liver metastases.

Patients who received everolimus achieved significantly longer median PFS than those in the placebo arm (6.9 months vs. 4.2 months; HR=0.59; 95% CI, 0.37-0.95).

A greater proportion of patients who received everolimus demonstrated an objective response (14.1% vs. 0%) and clinical benefit (45.3% vs. 30%).

Results from the overall study population — which included an additional 556 patients with ductal carcinoma — demonstrated a greater clinical benefit with everolimus vs. placebo (51.3% vs. 26.4%). Objective response rates in the overall population were 12.6% in the combination arm and 1.7% in the placebo arm.

Overall, toxicities were comparable between patients in the subset analysis and the overall study population. The most common adverse events among patients with invasive lobular carcinoma who received everolimus were stomatitis (50%), diarrhea (41%), nausea (36%), fatigue (34%) and rash (33%).

For more information:

Hortobagyi GN. Abstract #152. Presented at: Breast Cancer Symposium; Sept. 4-6, 2014; San Francisco.

Disclosure: The researchers report consultant/advisory roles and employment with; research funding, honoraria and travel expenses from; and stock ownership in Amgen, Antigen Express, AstraZeneca, Bayer, Chugai Pharma, Daiichi Sankyo, Eisai, Galena, Genentech, Nippon Kayaku, Novartis, Pfizer, Sanofi, Taiho Pharmaceutical and Takeda.