Randomized trial of first-line docetaxel + capecitabine (XT) versus docetaxel + epirubicin (ET) for metastatic breast cancer (MBC): Efficacy results of ERASME-4/CAPEDOC-EPIDOC

1049 Background: In MBC, XT improves time to progression and overall survival (OS) vs docetaxel alone (O'Shaughnessy, 2002) and first-line capecitabine + paclitaxel shows similar efficacy to epirubicin + paclitaxel (Luck, 2007). The ERASME-4 and CAPEDOC- EPIDOC trials were designed to assess the efficacy of XT vs ET as first-line therapy for MBC. Methods: Patients (pts) with MBC and no prior chemotherapy (adjuvant therapy permitted) were randomized to 3-weekly cycles of either XT (docetaxel 75 mg/m², d1 + capecitabine 1,000 mg/m² twice daily, d1–14) or ET (docetaxel 75 mg/m², epirubicin 75 mg/m², both d1). In the ET arm, primary prevention of febrile neutropenia with hematopoietic growth factor was recommended; ET pts received capecitabine at progression. The primary endpoint was progression-free rate 6 months after randomization. The planned sample size of 106 pts (Simon 1985), gave 95% power to test a progression-free rate of 75% (XT) vs 60% (ET). Secondary endpoints included progression-free survival (...