A prospective, randomized phase III trial comparing combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil with vinorelbine plus doxorubicin in the treatment of advanced breast carcinoma

BACKGROUND. A prospective, multicenter, randomized, Phase III trial comparing the efficacy of combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) with a combination of vinorelbine and doxorubicin (NA) in the treatment of patients with advanced breast carcinoma was u...

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Detalles Bibliográficos
Autores principales: Blajman, C., Balbiani, L., Block, J., Coppola, F., Chacon, R., Fein, L., Bonicatto, S., Alvarez, A., Schmilovich, A., Delgado, F.M.
Formato: JOUR
Materias:
Advanced breast carcinoma
Combination chemotherapy
Randomized controlled trials
cyclophosphamide
doxorubicin
fluorouracil
navelbine
article
breast carcinoma
cancer combination chemotherapy
cancer staging
cancer survival
clinical trial
controlled clinical trial
controlled study
drug efficacy
drug potency
female
human
major clinical study
phase 3 clinical trial
priority journal
randomized controlled trial
Adult
Aged
Antineoplastic Agents, Phytogenic
Antineoplastic Combined Chemotherapy Protocols
Breast Neoplasms
Cyclophosphamide
Disease Progression
Disease-Free Survival
Doxorubicin
Female
Fluorouracil
Humans
Middle Aged
Neoplasm Recurrence, Local
Prospective Studies
Survival Analysis
Treatment Outcome
Vinblastine
Acceso en línea:http://hdl.handle.net/20.500.12110/paper_0008543X_v85_n5_p1091_Blajman
Aporte de:
Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) de Universidad de Buenos Aires
Descripción
Sumario:BACKGROUND. A prospective, multicenter, randomized, Phase III trial comparing the efficacy of combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) with a combination of vinorelbine and doxorubicin (NA) in the treatment of patients with advanced breast carcinoma was undertaken. METHODS. One hundred and seventy-seven patients who previously were untreated for recurrent or metastatic breast carcinoma were entered into the study; 7 patients could not be assessed. The final analysis relates to 85 patients who were treated with FAC and 85 patients who were treated with NA, of whom 21 (25%) and 44 (52%), respectively, had received prior adjuvant chemotherapy. RESULTS. The overall response rates were similar for the two treatments and were unaffected by prior exposure to adjuvant therapy; overall response rate (ORR) for FAC was 74% (95% confidence interval [95% CI], 65-83%), and the ORR for NA was 75% (95% CI, 68-84%). The activity of NA in patients with liver involvement was greater than that of FAC in terms of survival. Overall survivals were similar, with a median of 17.3 months for patients receiving FAC and 17.8 months for patients receiving NA. Severe toxicity was uncommon with World Health Organization Grade 3-4 neutropenia affecting only 7% of patients in each arm of the study. NA was associated with a higher incidence of mild to moderate constipation, neurotoxicity, and phlebitis, whereas FAC produced a slight excess of mild cardiotoxicity. CONCLUSIONS. The efficacy of these two regimens is very similar, although NA may be more active in a subset of patients with visceral metastatic disease, particularly liver involvement. It is clear that, in a direct comparison with an established three-drug regimen, the newer two-drug combination of NA demonstrated equivalent activity with no significant excess of Grade 3-4 toxicity.

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