RANDOMIZED PHASE III TRIAL COMPARING EPIRUBICIN/ DOXORUBICIN PLUS DOCETAXEL AND EPIRUBICIN/ DOXORUBICIN PLUS PACLITAXEL AS FIRST LINE TREATMENT IN WOMEN WITH ADVANCED BREAST CANCER

Abstract

Background: The purpose of this study was to compare Epirubicin/ doxorubicin plus docetaxel and Epirubicin/ doxorubicin plus paclitaxel as first line treatment in women with advanced breast cancer.

Patients and methods: previously untreated patients with advanced breast cancer randomly assigned to recieve Epirubicin 75mg/m² and docetaxel 75 mg/m² (ED) 1-hour intravenous (IV) infusion every 21 days, Epirubicin 75 mg/m² and paclitaxel 175 mg/m² (EP) 3-hour IV infusion every 21 days, Intravenous bolus injections of doxorubicin 50 mg/m² and docetaxel 75 mg/m² (DD) administered as a 1-hour intravenous infusion every 21 days and doxorubicin 50 mg/m² and paclitaxel 175 mg/m² (DP) administered as a 1-hour intravenous infusion every 21 days. Previous anthracycline-based neo-adjuvant chemotherapy was allowed if completed ? 1 year before entering the study.

Results: Ten women patients were treated on arm ED &EP and median TTP was 10 versus 11 months, 50 women patients were trated on DD & DP cand median TTP was  8.5 versus 9 months respectively. Severe toxicity include grade 3-4 leukopenia (4% versus 2%), neutropenia (20% versus 22%) , anemia (38% versus 34%), thrombocytopenia (18% versus 24%), neurotoxicity (2% versus 6%) with DD and DP, respectively.

Conclusion: The DD and DP regimens have similar efficacy but different toxicity. Either regimen can be used as front- line treatment of ABC. But in case of ED and EP regimen was difficult to compare the result due to very small sample size.

Keywords: Epirubicin, doxorubicin, docetaxel, paclitaxel, advanced breast cancer, chemotherapy, neurotoxicity.