NATIONAL HARBOR, MD—Preliminary results of an ongoing trial suggest that a combination of trastuzumab, bevacizumab, and docetaxel is safe and effective as first-line therapy in women with metastatic breast cancer (MBC).
Fourteen of the 18 patients treated to date had a partial response or stable disease, a clinical benefit rate of 77.7, the investigators reported.
Previous studies have demonstrated the efficacy of trastuzumab combined with bevacizumab in MBC but the high rate of cardiotoxicity was a concern. Docetaxel has also been shown to be effective alone or combined with trastuzumab or bevacizumab. In the current study, Bhuvaneswari Ramaswamy, MD, of Ohio State University, Columbus, and her colleagues studied the safety and efficacy of the three drugs combined in previously untreated women with HER2-positive MBC. Their findings on the first 18 patients enrolled in the ongoing trial were reported at the 2010 American Society of Clinical Oncology Breast Cancer Symposium.
All patients received six cycles of trastuzumab, bevacizumab, and do cetaxel, after which docetaxel could be discontinued at the physician’s discretion. The other two agents were continued until disease progression or development of unacceptable toxicity.
Median progression-free survival was 56 weeks. Eight patients had a partial response and six had stable disease. Grade 3 and 4 nonhematologic toxicities included nausea, fatigue, diarrhea, wound dehiscence, retinal edema, pulmonary embolism, neuropathy, nephrotic syndrome, and hypertension. Grade 3 and 4 hematologic toxicities were neutropenia and febrile neutropenia. One patient had an asymptomatic drop in left ventricular ejection fraction after three cycles of therapy, but no grade 3 or 4 cardiotoxicity was observed.
Accrual in the study is continuing at two institutions