A phase II, randomized, multicenter study evaluating the combination of lapatinib and vinorelbine in women with ErbB2 overexpressing metastatic breast cancerReport as inadecuate




A phase II, randomized, multicenter study evaluating the combination of lapatinib and vinorelbine in women with ErbB2 overexpressing metastatic breast cancer - Download this document for free, or read online. Document in PDF available to download.

Breast Cancer Research and Treatment

, Volume 143, Issue 3, pp 493–505

First Online: 09 January 2014Received: 21 November 2013Accepted: 23 December 2013DOI: 10.1007-s10549-013-2828-z

Cite this article as: Janni, W., Sarosiek, T., Karaszewska, B. et al. Breast Cancer Res Treat 2014 143: 493. doi:10.1007-s10549-013-2828-z

Abstract

Lapatinib is approved in combination with capecitabine for treatment of patients with human epidermal growth factor receptor 2 HER2-positive metastatic breast cancer MBC who have progressed on prior trastuzumab in the metastatic setting. Vinorelbine is an important chemotherapy option for MBC. We evaluated efficacy and safety of lapatinib plus vinorelbine, compared with lapatinib plus capecitabine, in women with HER2-positive MBC. In this open-label, multicenter, phase II study, eligible patients N = 112 were randomized 2:1 to lapatinib plus vinorelbine N = 75 1,250 mg orally once daily QD continuously plus 20 mg-m-day intravenously or lapatinib plus capecitabine N = 37 1,250 mg orally QD continuously plus 2,000 mg-m-day orally, 2 doses. The primary endpoint was progression-free survival PFS. Other endpoints included overall survival OS and safety. Patients progressing within the study were given the option of crossover to the other treatment arm; time to second progression was an exploratory endpoint. Patient demographics, stratification, and prognostic factors were well balanced between treatments. Median PFS in both arms was 6.2 months 95 % confidence interval CI 4.2, 8.8 lapatinib plus vinorelbine; 4.4, 8.3 lapatinib plus capecitabine. Median OS on lapatinib plus vinorelbine was 24.3 months 95 % CI 16.4, NE and 19.4 months 95 % CI 16.4, 27.2 on lapatinib plus capecitabine. In total, 42 patients opted to cross over; median PFS was 3.2 months 95 % CI 1.7, 5.1 on lapatinib plus vinorelbine and 4.0 months 95 % CI 2.1, 5.8 on lapatinib plus capecitabine. Lapatinib plus vinorelbine offers an effective treatment option for patients with HER2-overexpressing MBC, having displayed comparable efficacy and tolerability rates to lapatinib plus capecitabine.

KeywordsBreast cancer HER2 Lapatinib Vinorelbine Capecitabine Electronic supplementary materialThe online version of this article doi:10.1007-s10549-013-2828-z contains supplementary material, which is available to authorized users.

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Author: Wolfgang Janni - Tomasz Sarosiek - Boguslawa Karaszewska - Joanna Pikiel - Elzbieta Staroslawska - Piotr Potemski - Christop

Source: https://link.springer.com/







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