Phase II trial of oral vinorelbine for treatment of metastatic breast cancer in women 65 years and older: N003A

Abstract

740 Background: Intravenous vinorelbine is a semi synthetic vinca alkaloid with known antitumor activity in breast cancer. The aim of this NCCTG phase II trial was to assess the efficacy and safety of oral vinorelbine in patients 65 years and older with metastatic breast cancer, as first or second line chemotherapy. Methods: Women 65 years and older with stage IV breast cancer, who had received at most one prior chemotherapy regimen for metastatic disease were enrolled in this one stage phase II study from January 2002 to February 2003. Prior adjuvant therapy was permitted. Oral vinorelbine gel capsules were administered at 60 mg/ m2 for 4 doses on days 1, 8, 15 and 22 of a 28 day cycle. Dose was increased to 70 mg/ m2 if at most one episode of grade 3 and no grade 4 myelosuppression occurred. Results: Twenty five eligible patients were enrolled. Characteristics: median age 73 (65–84); PS: 0 (40%), 1 (48%), 2 (12%); ER positive: 68%; prior adjuvant therapy: hormonal (36%), chemotherapy (36%), both (16%). Prior first line therapy: chemotherapy (32%); hormonal therapy (44%). Eleven (44%) had 3 or more metastatic sites, 18 (72%) had dominant visceral metastases. Twenty five patients were evaluable for response, all are off study treatment. Median cycles administered: 4 (1–20). For cycle 2, 11 patients were able to initiate the higher dose, 5 required 25% dose reduction. The overall response rate was 4% (90% CI: 0.1–20.4%); one patient achieved a partial response for 17.4 months. One patient (4%) maintained stable disease for more than 6 months while on treatment and progressed at 11.5 months. Median time to progression was 4.8 months (95% CI: 2.0–5.5 months) and the Kaplan-Meier estimated one-year survival was 48% (95% CI: 30–74.5%). Toxicity data were available for 24 patients. Grade 3 toxicities included neutropenia (13%), fatigue (13%), dizziness (8%) and leucopenia (8%). Others included grade 2 neuro-motor toxicity (13%) and neuro-sensory toxicity (8%). Conclusion: Oral vinorelbine was well tolerated but provided minimal anti-tumor activity at this dose in this population with metastatic breast cancer. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi Aventis, Bristol-Myers Squibb, Eli Lilly, Genentech, Pfizer