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Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer.
- Source :
-
Breast (Edinburgh, Scotland) [Breast] 2015 Dec; Vol. 24 (6), pp. 769-73. Date of Electronic Publication: 2015 Sep 16. - Publication Year :
- 2015
-
Abstract
- Lapatinib plus capecitabine (lap+cap) 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 vinorelbine (lap+vin), an important chemotherapy option for MBC, compared with lap+cap. In total, 112 patients were randomised 2:1 to treatment with lap+vin (N = 75) or lap+cap (N = 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 lap+vin arm, compared with 14 (38%) patients in the lap+cap arm (92% in both arms had discontinued treatment). Median OS in the lap+vin 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 lap+cap arm. The median follow-up in the lap+vin arm was 18.86 months (95% CI: 10.68, 26.02), compared with 19.38 (95% CI: 25.56) months in the lap+cap arm. Similar rates of death (56-57%) were observed in both arms. The final OS was consistent with the previously reported data and suggest that lap+vin offers an effective treatment option for women with HER2-positive MBC.<br /> (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Adult
Aged
Breast Neoplasms chemistry
Breast Neoplasms drug therapy
Breast Neoplasms pathology
Disease-Free Survival
Female
Follow-Up Studies
Humans
Lapatinib
Lymphatic Metastasis
Middle Aged
Survival Analysis
Treatment Outcome
Vinblastine administration & dosage
Vinorelbine
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Breast Neoplasms mortality
Quinazolines administration & dosage
Receptor, ErbB-2 analysis
Vinblastine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1532-3080
- Volume :
- 24
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Breast (Edinburgh, Scotland)
- Publication Type :
- Academic Journal
- Accession number :
- 26384789
- Full Text :
- https://doi.org/10.1016/j.breast.2015.08.005