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Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial

Lookup NU author(s): Professor Alan Calvert

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Abstract

Purpose: To compare the efficacy and tolerability of the combination of doxorubicin and paclitaxel (AT) with a standard doxorubicin and cyclophosphamide (AC) regimen as first-line chemotherapy for metastatic breast cancer. Patients and Methods: Eligible patients were anthracycline-naive and had bidimensionally measurable metastatic breast cancer. Two hundred seventy-five patients were randomly assigned to be treated with AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel 175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. A paclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) dose escalation was planned at cycle 2 if no grade greater than or equal to 3 neutropenia occurred in cycle 1. The primary efficacy end point was progression-free survival (PIPS). Secondary end points were response rate (RR), safety, overall survival (OS), and quality of life. Results: A median number of six cycles were delivered in the two treatment arms. The relative close-intensity and delivered cumulative dose of doxorubicin were lower in the AT arm. Dose escalation was only possible in 17% and 20% of the AT and AC patients, respectively. Median PFS was 6 months in the two treatments arms. RR was 58% versus 54%, and median OS was 20.6 versus 20.5 months in the AT and AC arms, respectively. The AT regimen was characterized by a higher incidence of febrile neutropenia, 32% versus 9% in the AC arm. Conclusion: No differences in the efficacy study end points were observed between the two treatment arms. Treatment-related toxicity compromised doxorubicin-delivered dose-intensity in the paclitaxel-based regimen (C) 2002 by American Society of Clinical Oncology.

Publication metadata

Author(s): Biganzoli, L., Cufer, T., Bruning, P., Coleman, R., Duchateau, L., Calvert, A. H., Gamucci, T., Twelves, C., Fargeot, P., Epelbaum, R., Lohrisch, C., Piccart, M. J.

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Oncology

Year: 2002

Volume: 20

Issue: 14

Pages: 3114-3121

ISSN (print): 0732-183X

ISSN (electronic): 1527-7755

URL: http://dx.doi.org/10.1200/JCO.2002.11.005

DOI: 10.1200/JCO.2002.11.005

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