Author/Editor		Biganzoli, Laura; Čufer, Tanja; Bruning, Peter; Coleman, Robert E; Duchateau, Luc; Rapoport, Bernardo; Nooij, Marianne; Delhaye, Francois; Miles, D; Sulkes, Aaron
Title		Doxorubicin-paclitaxel: a safe regimen in terms of cardiac toxicity in metastatic breast carcinoma patients. Results from a European organization for research and treatment of cancer multicenter trial
Type		članek
Source		Cancer
Vol. and No.		Letnik 97, št. 1
Publication year		2003
Volume		str. 40-5
Language		eng
Abstract		BACKGROUND. The potential cardiotoxicy of the doxorubicin-paclitaxel regimen, when paclitaxel is given shortly after the end of the anthracycline infusion, is an issue of concern, as suggested by small single institution Phase II studies. METHODS. In a large multicenter Phase III trial, 275 anthracycline naive metastatic breast carcinoma patients were randomized to receive either doxorubicin (60 mg/m2) followed 30 minutes later by paclitaxel (175 mg/ m2 3-hour infusion; AT) or a standard doxorubicin-cyclophosphamide regimen (AC; 60/600 mg/m2). Both treatments were given once every 3 weeks for a maximum of six cycles. Close cardiac monitoring was implemented in the study design. RESULTS. Congestive heart failure (CHF) occurred in three patients in the AT arm and in one patient in the AC arm (P = 0.62). Decreases in left ventricular ejection fraction to below the limit of normal were documented in 33% AT and 19% AC patients and were not predictive of CHF development. CONCLUSIONS. AT is devoid of excessive cardiac risk among metastatic breast carcinoma patients, when the maximum planned cumulative dose of doxorubicin does not exceed-360 mg/m2.
Descriptors		ADENOCARCINOMA CYCLOPHOSPHAMIDE BREAST NEOPLASMS DOXORUBICIN PACLITAXEL HEART FAILURE, CONGESTIVE NEOPLASM METASTASIS MULTICENTER STUDIES ANTINEOPLASTIC AGENTS, COMBINED DISEASE PROGRESSION DISEASE-FREE SURVIVAL FOLLOW-UP STUDIES HEART RISK FACTORS SURVIVAL ANALYSIS TREATMENT OUTCOME