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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial
Journal of the National Cancer Institute, Volume 100, No. 2, Year 2008
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Description
Background: Docetaxel is more effective than doxorubicin for patients with advanced breast cancer. The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration of doxorubicin and docetaxel. Methods: Patients with lymph node-positive breast cancer (n = 2887) were randomly assigned to one of four treatments: 1) sequential control (four cycles of doxorubicin at 75 mg/m2, followed by three cycles of cyclophosphamide, methotrexate, and 5-fluorouracil [CMF]); 2) concurrent control (four cycles of doxorubicin at 60 mg/m2 plus cyclophosphamide at 600 mg/m2, followed by three cycles of CMF); 3) sequential docetaxel (three cycles of doxorubicin at 75 mg/m2, followed by three cycles of docetaxel at 100 mg/m2, followed by three cycles of CMF); 4) concurrent docetaxel (four cycles of doxorubicin at 50 mg/m2 plus docetaxel at 75 mg/m2, followed by three cycles of CMF). The primary comparison evaluated the efficacy of including docetaxel regardless of schedule and was planned after 1215 disease-free survival (DFS) events (ie, relapse, second primary cancer, or death from any cause). Docetaxel and control treatment groups were compared by log-rank tests, and hazard ratios (HR) of DFS events were calculated by Cox modeling. All statistical tests were two-sided. Results: Due to a lower-than-anticipated rate of relapse, this analysis was performed after 5 years with 732 events. Patients in control arms had a 5-year DFS of 73% (95% confidence interval [CI] = 70% to 75%). Docetaxel treatment resulted in an improvement in DFS of borderline statistical significance compared with control treatment (HR = 0.86, 95% CI = 0.74 to 1.00; P =. 05). However, DFS in the sequential docetaxel arm was better than that in the concurrent docetaxel arm (HR = 0.83, 95% CI = 0.69 to 1.00) and in the sequential control arm (HR = 0.79, 95% CI = 0.64 to 0.98). Conclusions: Incorporating docetaxel into anthracycline-based therapy resulted in an improvement in DFS that was of borderline statistical significance. However, important differences may be related to doxorubicin and docetaxel scheduling, with sequential but not concurrent administration, appearing to produce better DFS than anthracycline-based chemotherapy. © The Author(s).
Authors & Co-Authors
Francis, Prudence A.
Australia, Melbourne
Peter Maccallum Cancer Centre
Australia, Newcastle
Australia and new Zealand Breast Cancer Trials Group
Switzerland, Bern
International Breast Cancer Study Group
Crown, John P.A.
Ireland, Dublin
All Ireland Cooperative Oncology Research Group
Di Leo, Angelo
Italy, Prato
Hospital of Prato
Buyse, Marc E.
Belgium, Louvain-la-neuve
International Drug Development Institute, Charleroi
Balil, Ana
Spain, Madrid
Geicam Grupo Geicam de Investigación en Cáncer de Mama
Spain, Valencia
Hospital Arnau de Vilanova
Andersson, Michael
Denmark, Copenhagen
Danish Breast Cancer Cooperative Group
Nordenskjòld, Bo A.
Sweden, Linkoping
Universitetssjukhuset I Linköping
Lang, Istvan
Hungary, Budapest
Országos Onkológiai Intézet Budapest
Jakesz, Raimund
Austria, Vienna
Medizinische Universität Wien
Vorobiof, Daniel Alberto
South Africa, Johannesburg
Sandton Oncology Centre
Gutiérrez, Jorge
Chile, Santiago
Clínica Las Condes
van Hazel, Guy Arthur
Australia, Perth
Mount Hospital
Dolci, Stella M.
Belgium, Brussels
Institut Jules Bordet
Jamin, Sophie
Belgium, Brussels
Institut Jules Bordet
Bendahmane, Belguendouz
France, Gentilly
Sanofi S.a.
Gelber, Richard D.
United States, Boston
Dana-farber Cancer Institute
Goldhirsch, Aaron
Italy, Milan
Istituto Europeo Di Oncologia
Castiglione-Gertsch, Monica
Switzerland, Bern
University Hospital Bern
Piccart-Gebhart, Martine J.
Belgium, Brussels
Institut Jules Bordet
Statistics
Citations: 167
Authors: 19
Affiliations: 20
Identifiers
Doi:
10.1093/jnci/djm287
ISSN:
00278874
e-ISSN:
14602105
Research Areas
Cancer
Environmental