ABSTRACT
The aim of this study was to investigate the efficacy and safety of Vinorelbine, 5 Fluorouracil and Folinic acid [Fu Fol-Nav] versus Paclitaxel [P] in patients with metastatic breast cancer [MBC] previously treated with Anthracycline. Between January 2001 and September 2003, 50 eligible patients with MBC were randomized to either Folinic acid 3Omg/m2 followed by 5Fu 600 mg/m2 given as intravenous holus injection then Vinorelbine 25 mglm2 [10 minute-infusion] q3 weeks [group A], or Paclitaxel 175 mg/m2 [3 hour infusion] q3 weeks [group B]. Eligibility criteri included: measurable MBC previous treatment with Anthracycline in [neo] adjuvant setting. The two randomized arms were well balanced for FuFol-Nav vs. P, median age [44 vs. 51], nearly three quarter of patients in each group had ECOG performance status 0,1. Hormonal receptor positivity for group A was 60% vs. 72% for group B, about half the patients had one metastatic site [56% vs. 47%] with predominant visceral sites in 68% vs. 60% in groups A and B respectively. Overall, both regimens were relatively well tolerated, grade 314 toxicities for group A vs. B: neutropenia and alopecia were significantly higher in group B: [28% vs. 8, 24% vs. 0] hut neurosensory [4% vs. 8%] and mucositis [8% vs. 4%] were not significantly different between the 2 groups. Other toxicities were mild and manageable and no treatment related mortality has been reported in both arms. Overall response rate was 44% [95% CI 42.1 to 45.9] for group A versus 48% [95% CI 46.9 to 50.1] in group B [P> 0.05]. Median time to progression TTP was 7.5 ms vs. 8ms in groups A and B respectively, median duration of response was comparable in both groups [8.5 vs 9ms]. Notably the median OS was similar in both arms [l3ms]. The present study failed to demonstrate a significant difference in response rate, median time to progression and overall survival between the two regimens, so FuFol-Nav is a well tolerated regimen with comparable efficiency as Paclitaxel hut with less cost burden in the treatment of MBC patients