Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer
| Autor: | Joanna Pikiel, Boguslawa Karaszewska, Michelle DeSilvio, Elżbieta Starosławska, Luca Marini, Kathryn Briggs, Christos Papadimitriou, Etienne Brain, Christoph Salat, Tomasz Sarosiek, Piotr Potemski, Wolfgang Janni, Christian Caglevic, Kim Mahood |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
medicine.medical_specialty Receptor ErbB-2 Phases of clinical research Breast Neoplasms Vinblastine Vinorelbine Lapatinib Gastroenterology Disease-Free Survival Capecitabine chemistry.chemical_compound Breast cancer HER2 Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Overall survival Aged Gynecology business.industry digestive oral and skin physiology General Medicine Middle Aged medicine.disease Survival Analysis Metastatic breast cancer Treatment Outcome Docetaxel chemistry Trastuzumab emtansine Lymphatic Metastasis Quinazolines Female Surgery business human activities Follow-Up Studies medicine.drug |
| Zdroj: | The Breast. 24(6):769-773 |
| ISSN: | 0960-9776 |
| DOI: | 10.1016/j.breast.2015.08.005 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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