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Abstract:

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.

Registro:

Documento: Artículo
Título: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
Autor:Blajman, C.; Balbiani, L.; Block, J.; Coppola, F.; Chacon, R.; Fein, L.; Bonicatto, S.; Alvarez, A.; Schmilovich, A.; Delgado, F.M.
Filiación:Argentina Oncology Group, Buenos Aires, Argentina
Inst. de Recherche Pierre Fabre-45, Boulogne, France
Arcos 2626, 1428 Buenos Aires, Argentina
Palabras clave: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
Año:1999
Volumen:85
Número:5
Página de inicio:1091
Página de fin:1097
DOI: http://dx.doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1091::AID-CNCR12>3.0.CO;2-A
Título revista:Cancer
Título revista abreviado:Cancer
ISSN:0008543X
CODEN:CANCA
CAS:Antineoplastic Agents, Phytogenic; CAF protocol; Cyclophosphamide, 50-18-0; Doxorubicin, 23214-92-8; Fluorouracil, 51-21-8; Vinblastine, 865-21-4; vinorelbine, 71486-22-1
Registro:https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_0008543X_v85_n5_p1091_Blajman

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Citas:

---------- APA ----------
Blajman, C., Balbiani, L., Block, J., Coppola, F., Chacon, R., Fein, L., Bonicatto, S.,..., Delgado, F.M. (1999) . 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. Cancer, 85(5), 1091-1097.
http://dx.doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1091::AID-CNCR12>3.0.CO;2-A
---------- CHICAGO ----------
Blajman, C., Balbiani, L., Block, J., Coppola, F., Chacon, R., Fein, L., et al. "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" . Cancer 85, no. 5 (1999) : 1091-1097.
http://dx.doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1091::AID-CNCR12>3.0.CO;2-A
---------- MLA ----------
Blajman, C., Balbiani, L., Block, J., Coppola, F., Chacon, R., Fein, L., et al. "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" . Cancer, vol. 85, no. 5, 1999, pp. 1091-1097.
http://dx.doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1091::AID-CNCR12>3.0.CO;2-A
---------- VANCOUVER ----------
Blajman, C., Balbiani, L., Block, J., Coppola, F., Chacon, R., Fein, L., et al. 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. Cancer. 1999;85(5):1091-1097.
http://dx.doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1091::AID-CNCR12>3.0.CO;2-A