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Vinorelbine plus trastuzumab combination as first-line therapy for HER 2-positive metastatic breast cancer patients: an international phase II trial

2006; Springer Nature; Volume: 95; Issue: 7 Linguagem: Inglês

10.1038/sj.bjc.6603351

1532-1827

Arlene Chan, M Martín, Michael Untch, Marta Gil, V Guillem-Porta, Marek Z. Wojtukiewicz, Pirkko Kellokumpu‐Lehtinen, Harald Sommer, V. Georgoulias, Nicola Battelli, Marek Pawlicki, D. Aubert, T. Bourlard, J. Gasmi, G. Villanova, Luboš Petruželka,

Peptidase Inhibition and Analysis

The aim of this international phase II trial was to determine the efficacy and safety profile of weekly vinorelbine plus trastuzumab as first-line chemotherapy for women with HER 2-overexpressing metastatic breast cancer. Sixty-nine patients with tumours overexpressing HER 2 received vinorelbine: 30 mg m−2 week−1 and trastuzumab: 4 mg kg−1 on day 1 as a loading dose followed by 2 mg kg−1 week−1 starting on day 8. Sixty-two patients were evaluable for response and 69 patients were evaluable for toxicity. The overall response rate was 62.9%. The median time to response was 8.4 weeks, the median duration of response was 17.5 months, the median progression-free survival was 9.9 months (95% CI, 5.6–12.1) and the one-year progression-free survival was 39.1%. The median survival for all patients was 23.7 months (95% CI, 18.4–32.6). This regimen was safe: grade 3–4 neutropenia were observed over 17.7% of courses in 83.8% of patients, with only two episodes of febrile neutropenia (0.1%) in two patients (2.9%). Only one patient discontinued treatment due to grade 3 symptomatic cardiac dysfunction that resolved with therapy. Vinorelbine plus trastuzumab is one of the most active treatment regimens for patients with HER 2-positive metastatic breast cancer and demonstrates a very favourable safety profile allowing prolonged treatment with long-term survival. This study has been presented in part at the following conferences: The San Antonio Breast Cancer Symposium, San Antonio, TX, USA, 2003; The American Society of Clinical Oncology, Orlando, FL, USA, 2005.