SAN ANTONIO—Adding the antibody antiangiogenic therapy ramucirumab to docetaxel does not improve progression-free survival (PFS) or overall survival (OS) among patients with HER2-negative, advanced breast cancer, according to the interim analysis of a placebo-controlled, randomized phase 3 clinical study presented at the 2013 San Antonio Breast Cancer Symposium.
“We had hoped that ramucirumab would give patients a new option for metastatic breast cancer,” said John R. Mackey, MD, professor of oncology at the University of Alberta in Edmonton, Canada. “Antiangiogenic agents have been successful in prolonging survival in a number of solid tumor types, including colon cancer and gastric cancer, but unfortunately, for reasons we don’t understand, they have not yet been shown to work for breast cancer.”
“Not every new drug pans out, and sometimes knowing this is a road we don’t want to go down is important,” commented panel moderator Peter Ravdin, MD, PhD, clinical professor of oncology at the University of Texas Health Science Center in San Antonio, TX.
The Ramucirumab Overall Survival Evaluation (ROSE) trial, also known as TRIO-12, enrolled 1,144 participants and randomly assigned them 1:2 to receive docetaxel plus either ramucirumab or placebo. At a median follow-up of 16.2 months, PFS for patients in the ramucirumab and placebo arms were 9.5 months and 8.2 months, respectively (P = 0.077, not significant). Median OS was 27.3 and 27.2 months, respectively (P = 0.92, not significant).
“Ramucirumab plus docetaxel therapy had higher rates of adverse events including fatigue, hypertension, bleeding, febrile neutropenia and stomatitis,” Dr. Mackey reported.
The study was funded by Eli Lilly.
- Mackey JR. S5-04. Presented at: San Antonio Breast Cancer Symposium 2013. Dec. 10-14, 2013; San Antonio.