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  • Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European organizationfor research and treatment of cancer 10961 multicenter phase III trial
    Biganzoli, L... ...
    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 breastcancer. Patients and methods: Eligible patients were anthracycline-naiveand had bidimensionally measurable metastatic breast cancer. Two hundred seventy-five patients were randomly assigned to be treatedwith AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) pluscyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. Apaclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) dose escalation was planned at cycle 2 if no grade >or= 3 neutropenia occurred in cycle 1. Theprimary efficacy end point was progression-free survival (PFS). Secondary end points were response rate (RR), safety, overall survival (OS), and qualityof life. Result: A median number of six cycles were delivered in the two treatment arms. The relative dose-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.
    Source: Journal of clinical oncology. - ISSN 0732-183X (Letn. 20, št. 14, 2002, str. 3114-3121)
    Type of material - article, component part
    Publish date - 2002
    Language - english
    COBISS.SI-ID - 15339993

source: Journal of clinical oncology. - ISSN 0732-183X (Letn. 20, št. 14, 2002, str. 3114-3121)
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