Phase II study of epirubicin, oxaliplatin and docetaxel combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Abstract

Background. This phase II study was designed to evaluate the activity and safety of a combination of epirubicin, oxaliplatin and docetaxel in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Methods. Forty patients with measurable distant metastases received epirubicin 50 mg/m 2, docetaxel 60 mg/m2 followed by oxaliplatin 100 mg/m2 on day 1 of each 21-day cycle. Primary end point was response rates (RR). Results. All patients were evaluable. The overall RR was 47.5% (95% confidence interval (CI) 32-63). The disease control was 80%. Median time for response was 6 weeks. Median time to progression was 6.3 months (95% CI 5.4-7.2) and the median overall survival time was 12.1 months (95% CI 10.7-13.5). Grade 3/4 neutropenia occurred in 50% of patients with two episodes of febrile neutropenia (5%). Other non-hematological grade 3 toxicities included sensory neuropathy in two patiens (5%), vomiting and mucositis in two patients (5%) and diarrhea in one patient (2.5%). Conclusion. The combination of epirubicin, oxaliplatin and docetaxel was found to be effective and well tolerated in patiens with metastatic gastric or GEJ adenocarcinoma and maybe an appropriate regimen to be used in the neoadjuvant setting and with molecularly targeted agents.