Gemcitabine/Epirubicin/Paclitaxel Trials in Advanced Breast Cancer

ABSTRACT: Numerous trials have shown that the pharmacokineticinterferences of epirubicin (Ellence)/paclitaxel (Taxol) combinations produceless pharmacodynamic effect than doxorubicin/paclitaxel regimens. Paclitaxel ismore easily combined when infused over 3 (as compared to 24) hours; theadministration of optimal doses of both agents is important. Based on thesefindings, a phase II study was performed to evaluate the feasibility andactivity of the combination of gemcitabine (Gemzar), epirubicin, and paclitaxelas first-line therapy in advanced breast cancer. Patients received gemcitabineat 1,000 mg/m2 on days 1 and 4, plus epirubicinat 90 mg/m2 on day 1, plus paclitaxel at 175mg/m2/d on day 1 every 21 days. After sixcourses, patients less than 60 years old and in complete or partial remission orstable disease were treated with high-dose chemotherapy as consolidationtreatment. The overall response rate was 92%, with 31% complete responses; 25patients received high-dose chemotherapy, achieving a final overall responserate of 97%, with 47% complete responses. At a median follow-up of 25 months,median progression-free survival is 21 months. Grade 4 neutropenia was observedin 64% of patients. Other hematologic toxicities were mild. Mild to moderateperipheral neuropathy was experienced by 39% of patients; grade 2 or 3 mucositisoccurred in 25% and 17% of patients, respectively. Based on these results, amulticenter trial has been started in seven Italian centers to confirm thefeasibility of this regimen. [ONCOLOGY 15(Suppl 3):41-43, 2001]

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