Abstract
542 Background: The aim of this study was to assess efficacy and safety of vinflunine (Javlor), a novel semi-synthetic vinca alkaloid, in patients with metastatic breast cancer who have progressed on or after anthracycline-taxane based regimens. Methods: So far, from 60 patients enrolled, for this analysis, 52 patients have been evaluated for safety and 45 patients for efficacy. Median age was 55 years [33–75], median Karnofsky's Performance Status was 90% [70–100]. Visceral involvement was present in 45 patients (86.5%), and 38 patients (73.1%) had liver metastases. VFL was administered intravenously at 320 mg/m2 every 21 days.Results: A total of 228 cycles with a median of 6 cycles [1–12] were analysed. Dose reduction was required in 11.4% cycles (36.5% patients). Relative dose intensity was 96.3%[50.4–104.7]. Safety: Grade ≥ 3 main related toxicities were: neutropenia 37.1% cycles (63.5% patients), neutropenic infection 1.3% cycles (5.8% patients), constipation 5.7% cycles (19.2% patients), abdominal pain 3.5% cycles (13.5% patients), nausea 2.2% cycles (9.6% pts), vomiting 2.2% cycles (7.7% patients). No grade ≥3 related peripheral neuropathy was observed. Efficacy: Partial response (PR) confirmed by independent review was obtained in 16 out of 45 evaluable patients (35.6%) [CI95%22—50], and stable disease in 15 patients (33.3%). By an intent to treat analysis PR was 30.8% and median progression free survival was 4.2 months [2.8–4.8]. From 16 out of 45 patients with a progression free interval < 3 months after taxane exposure, 7 patients (43.8%) achieved a partial response. Conclusions: Vinflunine has a high level of activity after anthracycline-taxane exposure, even in patients considered taxane-refractory (progression free interval after < 3 months). Its toxicity was manageable and reversible. Further phase III development is planned. Updated results and PK data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pierre Fabre Aventis Aventis Pierre Fabre
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