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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todo:paper_0008543X_v85_n5_p1091_Blajman2023-10-03T14:06:11Z 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 Blajman, C. Balbiani, L. Block, J. Coppola, F. Chacon, R. Fein, L. Bonicatto, S. Alvarez, A. Schmilovich, A. Delgado, F.M. 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 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. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_0008543X_v85_n5_p1091_Blajman |
| institution |
Universidad de Buenos Aires |
| institution_str |
I-28 |
| repository_str |
R-134 |
| collection |
Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) |
| topic |
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 |
| spellingShingle |
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 Blajman, C. Balbiani, L. Block, J. Coppola, F. Chacon, R. Fein, L. Bonicatto, S. Alvarez, A. Schmilovich, A. Delgado, F.M. 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 |
| topic_facet |
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 |
| description |
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. |
| format |
JOUR |
| author |
Blajman, C. Balbiani, L. Block, J. Coppola, F. Chacon, R. Fein, L. Bonicatto, S. Alvarez, A. Schmilovich, A. Delgado, F.M. |
| author_facet |
Blajman, C. Balbiani, L. Block, J. Coppola, F. Chacon, R. Fein, L. Bonicatto, S. Alvarez, A. Schmilovich, A. Delgado, F.M. |
| author_sort |
Blajman, C. |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| url |
http://hdl.handle.net/20.500.12110/paper_0008543X_v85_n5_p1091_Blajman |
| work_keys_str_mv |
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