Biweekly vinorelbine and tegafur/uracil in patients with metastatic breast cancer previously treated with anthracyclines and taxanes:: GEICAM 2000�02 phase II study

• Autores: A. Antón Torres, Agustí Barnadas i Molins, Jesús Florián Jericó, Nuria Ribelles Entrena, María Lomas Garrido, Juan Lao, Ana González-Quintás, Mireia Margelí Vila, Ana Belén Paules, Javier Gayo, Manuel Ramos Vázquez
• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 13, Nº. 4, 2011, págs. 281-286
• Idioma: inglés
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• Resumen

  • Introduction To assess the efficacy and safety profile of biweekly vinorelbine and tegafur/uracil (UFT) as treatment in patients with metastatic breast cancer previously treated with anthracyclines and taxanes.

    Patients and methods Patients with histologically confirmed breast cancer, measurable disease, no more than one prior chemotherapy regimen for metastatic disease, an Eastern Cooperative Oncology Group (ECOG) performance status ?2, and adequate bone marrow, renal and liver function were eligible. Patients received vinorelbine (30 mg/m2 on day 1) and UFT (250 mg/m2 daily) every two weeks for 12 cycles unless progression or unacceptable toxicity was observed.

    Results Thirty-seven patients were included and received 311 cycles of chemotherapy. Efficacy and toxicity analyses were carried out on an intention-to-treat basis. The overall response rate was 35% (95% CI: 20�53). With a median follow-up of 18.6 months (95% CI: 1.0�74.3), the median time to progression was 7.0 months (96% CI: 5.2�8.9) and the median overall survival was 19.4 months (95% CI: 11.1�27.8). The most common severe toxicities were neutropenia (38% of patients) and asthenia (11% of patients).

    Conclusion The combination of biweekly vinorelbine and UFT in patients with metastatic breast cancer pretreated with anthracyclines and taxanes is a well tolerated and effective regimen. AEMPS Trial Registration No.: 00-0534.