Oral Vinorelbine in Patients With Endocrine-Pretreated Breast Cancer
Based on the findings of the NORBREAST-228 phase II trial, first-line oral vinorelbine chemotherapy may prove to be an active alternative to intravenous chemotherapy in endocrine-pretreated patients with hormone receptor–positive metastatic breast cancer with bone metastases but no visceral involvement. Guenther G. Steger, MD, Chair for Medical Breast Cancer Research at the Medical University of Vienna, Austria, and colleagues reported the preliminary results with this oral therapy in Clinical Breast Cancer.
A total of 70 patients received a median of 6 cycles of oral vinorelbine (60 mg/m2 on days 1, 8, 15, and 22 every 4 weeks) until disease progression or unacceptable toxicity. In the absence of grade 3/4 toxicity, the dose was escalated to 80 mg/m2 from cycle 2. Nearly three-quarters of patients continued treatment until disease progression.
With a median follow-up of 43 months, the median progression-free survival was 8.2 months, with a clinical benefit rate of 56%. The median overall survival was 35.2 months.
Although neutropenia was the most common grade 3/4 adverse event, occurring in 38% of patients, no febrile neutropenia was reported. Bone pain, fatigue, and gastrointestinal side effects were the most common grade 1/2 toxicities.