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Overall survival benefit for sequential doxorubicin-docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer-8-year results of the Breast International Group 02-98 phase III trial
Hospital Prato, Italy .
Peter MacCallum Cancer Centre, Australia .
Irish Clin Oncology Research Grp, Ireland .
Int Institute Drug Dev, Belgium .
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2013 (English)In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 24, no 5, 1203-1211 p.Article in journal (Refereed) Published
Abstract [en]

Background: In women with node-positive breast cancer, the Breast International Group (BIG) 02-98 tested the incorporation of docetaxel (Taxotere) into doxorubicin (Adriamycin)-based chemotherapy, and compared sequential and concurrent docetaxel. At 5 years, there was a trend for improved disease-free survival (DFS) with docetaxel. We present results at 8-year median follow-up and exploratory analyses within biologically defined subtypes. less thanbrgreater than less thanbrgreater thanMethods: Patients were randomly assigned to one of four treatments: (i) sequential control: doxorubicin (A) (75 mg/m(2)) x 4 -andgt; classical cyclophosphamide, methotrexate, 5-fluorouracil (CMF); (ii) concurrent control: doxorubicin, cyclophosphamide (AC)(60/600 mg/m(2)) x 4 -andgt; CMF; (iii) sequential docetaxel: A (75 mg/m(2)) x3 -andgt; docetaxel (T) (100 mg/m(2)) x3. CMF and (iv) concurrent docetaxel: AT(50/75 mg/m(2)) x 4 -andgt; CMF. The primary comparison evaluated docetaxel efficacy regardless of the schedule. Exploratory analyses were undertaken within biologically defined subtypes. less thanbrgreater than less thanbrgreater thanResults: Two thousand eight hundred and eighty-seven patients were enrolled. After 93.4 months of median follow-up, there were 916 DFS events. For the primary comparison, there was no significant improvement in DFS from docetaxel [hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.80-1.05, P = 0.187]. In secondary comparisons, sequential docetaxel significantly improved DFS compared with sequential control (HR = 0.81, 95% CI = 0.67-0.99, P = 0.036), and significantly improved DFS (HR = 0.84, 95% CI = 0.72-0.99, P = 0.035) and overall survival (OS) (HR = 0.79, 95% CI = 0.65-0.98, P = 0.028) compared with concurrent doxorubicin-docetaxel. Luminal-A disease had the best prognosis. HRs favored addition of sequential docetaxel in all subtypes, except luminal-A; but this observation was not statistically supported because of limited numbers. less thanbrgreater than less thanbrgreater thanConclusion: With further follow-up, the sequential docetaxel schedule resulted in significantly better OS than concurrent doxorubicin-docetaxel, and continued to show better DFS than sequential doxorubicin-based control.

Place, publisher, year, edition, pages
Oxford University Press (OUP): Policy A1 , 2013. Vol. 24, no 5, 1203-1211 p.
Keyword [en]
adjuvant, breast cancer, chemotherapy, docetaxel, doxorubicin, sequential
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-93386DOI: 10.1093/annonc/mds627ISI: 000318105000008OAI: diva2:624498

Funding Agencies|sanofi-aventis||Associazione Italiana Ricerca Cancro (AIRC), Milan, Italy||National Health and Medical Research Council|100925351164|Sanofi||Roche||Novartis||

Available from: 2013-05-31 Created: 2013-05-31 Last updated: 2013-05-31

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