Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer

Wolfgang Janni, Tomasz Sarosiek, Boguslawa Karaszewska, Joanna Pikiel, Elzbieta Staroslawska, Piotr Potemski, Christoph Salat, Etienne Brain, Christian Caglevic, Kathryn Briggs, Kim Mahood, Michelle DeSilvio (+2 others)
2015 Breast  
Lapatinib plus capecitabine (lapþcap) is approved as treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC), who have progressed on prior trastuzumab in the metastatic setting. We previously reported progression-free survival (PFS), overall survival (OS) and safety results from this open-label, multicentre, phase II study (VITAL; NCT01013740) conducted in women with HER2 positive MBC, to evaluate the efficacy and safety of lap plus
more » ... orelbine (lapþvin), an important chemotherapy option for MBC, compared with lapþcap. In total, 112 patients were randomised 2:1 to treatment with lapþvin (N ¼ 75) or lapþcap (N ¼ 37). Results showed that the median PFS (primary endpoint) and OS (secondary endpoint) post-randomisation were comparable between treatment arms, with no new safety signals detected. Here, we assessed the final OS in this study at 40 months post-randomisation. At the time of final analyses, 24 (32%) patients were ongoing in the lapþvin arm, compared with 14 (38%) patients in the lapþcap arm (92% in both arms had discontinued treatment). Median OS in the lapþvin arm was 23.3 months (95% confidence intervals [CI]: 18.5, 31.1), compared with 20.3 months (95% CI: 16.4, 31.8) in the lapþcap arm. The median follow-up in the lapþvin arm was 18.86 months (95% CI: 10.68, 26.02), compared with 19.38 (95% CI: 25.56) months in the lapþcap arm. Similar rates of death (56e57%) were observed in both arms. The final OS was consistent with the previously reported data and suggest that lapþvin offers an effective treatment option for women with HER2-positive MBC.
doi:10.1016/j.breast.2015.08.005 pmid:26384789 fatcat:64mebnnxkjbn5nvbzmnzkn37lq