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

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... 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.