Resumen de 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
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
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.
