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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: Results of a randomized, multicenter, phase III trial
Journal of Clinical Oncology, Volume 21, No. 6, Year 2003
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Description
Purpose: This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC). Patients and Methods: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m 2 plus docetaxel 75 mg/m2 (n = 214) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (n = 215) on day 1, every 3 weeks for up to eight cycles. Results: Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank p = .014; median TTF, 25.6 v 23.7 weeks; log-rank P = .048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P = .009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P < .001; 8% v 2%, P = .01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%). Conclusion: AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC. © 2003 by American Society of Clinical Oncology.
Authors & Co-Authors
Nabholtz, Jean Marc A.
South Africa, Pretoria
University of Pretoria
Falkson, Carla Isadora
South Africa, Pretoria
University of Pretoria
Arrabal-Martín, Miguel
South Africa, Pretoria
University of Pretoria
Chan, Stephen Y.T.
South Africa, Pretoria
University of Pretoria
Piénkowski, Tadeusz J.
South Africa, Pretoria
University of Pretoria
Załuski, Jerzy
South Africa, Pretoria
University of Pretoria
Pintér, Tamás
South Africa, Pretoria
University of Pretoria
Krzakowski, M. J.
South Africa, Pretoria
University of Pretoria
Vorobiof, Daniel Alberto
South Africa, Pretoria
University of Pretoria
Leonard, Robert C.F.
South Africa, Pretoria
University of Pretoria
Azli, Nasser
South Africa, Pretoria
University of Pretoria
Pouillart, Pierre
South Africa, Pretoria
University of Pretoria
Statistics
Citations: 379
Authors: 12
Affiliations: 1
Identifiers
Doi:
10.1200/JCO.2003.04.040
ISSN:
0732183X
Research Areas
Cancer
Noncommunicable Diseases