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.
Data(s) |
01/07/2002
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Resumo |
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 >or= 3 neutropenia occurred in cycle 1. The primary efficacy end point was progression-free survival (PFS). 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 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 Clinical Trial Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't info:eu-repo/semantics/published |
Formato |
No full-text files |
Identificador |
uri/info:pmid/12118025 http://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/55266 |
Idioma(s) |
en |
Fonte |
Journal of clinical oncology, 20 (14 |
Palavras-Chave | #Sciences bio-médicales et agricoles #Adult #Aged #Antineoplastic Combined Chemotherapy Protocols -- adverse effects #Antineoplastic Combined Chemotherapy Protocols -- therapeutic use #Breast Neoplasms -- drug therapy #Breast Neoplasms -- pathology #Cyclophosphamide -- administration & dosage #Disease Progression #Disease-Free Survival #Doxorubicin -- administration & dosage #Drug Administration Schedule #Europe #Female #Humans #Middle Aged #Paclitaxel -- administration & dosage #Survival Analysis #Treatment Outcome |
Tipo |
info:eu-repo/semantics/article info:ulb-repo/semantics/articlePeerReview info:ulb-repo/semantics/openurl/article |