Weekly schedule of vinorelbine in pretreated breast cancer patients

Purpose: In this phase II study, we explored tolerability and activity of v inorelbine administered according to a dose-dense weekly schedule with hema topoietic growth factor support in pretreated, advanced breast cancer patie nts. Patients and Methods: From January 1994 to March 1996, 40 patients with met astatic breast cancer, pretreated with at least one prior anthracycline-con taining regimen, were entered into the study. Patient characteristics: medi an age 53 years (range 32-70); ECOG performance status 0-1: 34 patients, 2: 6 patients; dominant visceral metastatic disease: 15 patients, dominant no n-visceral: 25; anthracycline-refractory/resistant: 2 patients, sensitive: 38 patients. Six patients were treated as first-line therapy for metastatic disease and 34 in second- or subsequent lines. All patients received vinorelbine at the dose of 25 mg/m(2)/week as a short intravenous infusion, together with routine antiemetic medication. Granulo cyte-colony stimulating factor (Lenograstim) at the dose of 150 mu g/m(2) s ubcutaneously on day 3 was included in the treatment schedule. Results: The median number of treatment weeks was 23 (range: 4-24), with a delivered dose-intensity (DDI) of 23.8 mg/m(2)/week (range: 18.7-25, 95.2% of projected dose-intensity). Toxicity was mild, with non-complicated neutropenia being the main toxicity observed (grade 3-4 in 25% of the patients but only 2% of treatment weeks) . Overall response rate was 52.5%, with complete responses in 12.5% of pati ents. Median duration of the response and median time to progression were 1 0 and 9 months, respectively. Median overall survival was 19 months. Conclusion: Dose-dense weekly vinorelbine is safe and effective with minima l toxicity in pretreated advanced breast cancer patients.