Doses of capecitabine and oral vinorelbine are not relevant for efficacy in breast cancer patients: an analysis of dose intensity.

Background: The combination of capecitabine and vinorelbine is a valuable regimen in metastatic breast cancer treatment, even in pretreated patients.

Patients And Methods: Forty-one pretreated consecutive patients were treated with capecitabine, 1000 mg/m2, twice daily, for two of three weeks, and vinorelbine, given orally at a dose of 60 mg/m2, days 1 and 8 in three-week cycles.

Results: A total of 301 courses was given, with a median of 8 courses (range, 3-13). Median dose intensity of capecitabine was 75% of the planned dose and for vinorelbine it was 72%. We observed 18 partial response (43.9%), 15 stable disease (36.6%), and 8 progressive disease (19.5%). Median progression-free survival was 9 months (range, 1-22) and median overall survival was 27.2 months (range, 4-40). Overall response rate (complete + partial response) was not statistically different between patients who received more or less than the median dose intensity of capecitabine and vinorelbine, and there was no difference in overall survival or progression-free survival. CONCLUSIONS; Capecitabine and oral vinorelbine is an effective and well-tolerated "all-oral" regimen for advanced breast cancer patients. The use of lower doses than those currently recommended should be not detrimental in terms of efficacy.