BACKGROUND: The potential cardiotoxicity 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/m(2)) followed 30 minutes later by paclitaxel (175 mg/m(2) 3-hour infusion; AT) or a standard doxorubicin-cyclophosphamide regimen (AC; 60/600 mg/m(2)). 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/m(2). Copyright 2003 American Cancer Society.
RCT Entities:
BACKGROUND: The potential cardiotoxicity 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 carcinomapatients were randomized to receive either doxorubicin (60 mg/m(2)) followed 30 minutes later by paclitaxel (175 mg/m(2) 3-hour infusion; AT) or a standard doxorubicin-cyclophosphamide regimen (AC; 60/600 mg/m(2)). 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 carcinomapatients, when the maximum planned cumulative dose of doxorubicin does not exceed 360 mg/m(2). Copyright 2003 American Cancer Society.
Authors: Arlene O Siefker-Radtke; Matthew T Campbell; Mark F Munsell; Deborah R Harris; Robert L Carolla; Lance C Pagliaro Journal: Urology Date: 2015-12-23 Impact factor: 2.649
Authors: Davina Ghersi; Melina L Willson; Matthew Ming Ki Chan; John Simes; Emma Donoghue; Nicholas Wilcken Journal: Cochrane Database Syst Rev Date: 2015-06-10
Authors: Alistair M Middleton; Joe Reynolds; Sophie Cable; Maria Teresa Baltazar; Hequn Li; Samantha Bevan; Paul L Carmichael; Matthew Philip Dent; Sarah Hatherell; Jade Houghton; Predrag Kukic; Mark Liddell; Sophie Malcomber; Beate Nicol; Benjamin Park; Hiral Patel; Sharon Scott; Chris Sparham; Paul Walker; Andrew White Journal: Toxicol Sci Date: 2022-08-25 Impact factor: 4.109