High-dose DICEP chemotherapy versus observation in metastatic breast cancer patients with monotopic disease responding to induction chemotherapy with paclitaxel plus epirubicin. Final results of a phase III GEICAM trial

• Autores: Emilio Alba, María Dolores Menéndez, Antonio Casado Herráez, Amadeu Pelegrí, Miguel Martín Jiménez, María del Carmen Talavera, Ana Balil, Álvaro Rodríguez Lescure, José Luis García Puche
• Localización: Revista de oncología: Publicación oficial de la Federación de Sociedades Españolas de Oncología y del Instituto Nacional de Cancerología de México, ISSN 1575-3018, Vol. 5, Nº. 3, 2003, págs. 148-155
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Purpose. To determine the efficacy of high-dose consolidation DICEP chemotherapy (HD-DICEP) in prolonging progression free survival (PFS) of chemotherapy-responsive metastatic breast cancer (MBC) patients with monotopic disease.

    Patients and methods. Patients with MBC and only one metastatic site were administered 6 courses of paclitaxel plus epirubicin (ET). Patients with complete responses or partial responses that could be treated with radical radiotherapy were randomized to receive or not two courses of HD-DICEP. All patients were to be treated with radical radiotherapy when feasible.

    Results. The response rate to induction ET was 86% (44 of 51 eligible patients, 95% c.i. 74%-94%). 38 patients were actually randomized after ET. After a median follow-up of 42 months for patients still alive, the median PFS was of 13 months (DICEP) and 16 months (observation), respectively (p = 0.028). Median OS was similar in both arms (58 months vs 58 months, p = 0.91). Four patients (11% of all randomized patients, one in DICEP and three in observation) are continuously free of disease, for 4 or more years. No toxic deaths occurred.

    Conclusion. In this study, consolidation HD-DICEP was unable to prolong PFS or OS of patients with monotopic MBC Purpose. To determine the efficacy of high-dose consolidation DICEP chemotherapy (HD-DICEP) in prolonging progression free survival (PFS) of chemotherapy-responsive metastatic breast cancer (MBC) patients with monotopic disease.