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
- Alba, Emilio
- Menéndez, María Dolores
- Casado Herráez, Antonio
- Pelegrí, Amadeu
- Martín Jiménez, Miguel
- Talavera, María del Carmen
- Balil, Ana
- Rodríguez Lescure, Álvaro
- García Puche, José Luis
ISSN: 1575-3018
Año de publicación: 2003
Volumen: 5
Número: 3
Páginas: 148-155
Tipo: Artículo
Otras publicaciones en: Revista de oncología: Publicación oficial de la Federación de Sociedades Españolas de Oncología y del Instituto Nacional de Cancerología de México
Objetivos de desarrollo sostenible
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.