1. ¹Division of Medical Oncology B, 'Regina Elena' Institute for Cancer Research, Via Elio Chianesi, 53, Rome 00144, Italy
2. ²Division of Medical Oncology, San Giuseppe Hospital, Albano Laziale 00041, Italy
3. ³Division of Medical Oncology, Toraldo Hospital, Tropea 88038, Italy
4. ⁴Biostatistics Unit, 'Regina Elena' Institute for Cancer Research, Rome 00144, Italy

Correspondence: Dr L Di Lauro, E-mail: dilauro@ifo.it

Received 18 May 2007; Revised 4 July 2007; Accepted 9 July 2007; Published online 31 July 2007.

Abstract

This phase II study was designed to evaluate the activity and safety of a combination of irinotecan, docetaxel and oxaliplatin in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Forty patients with measurable distant metastasis received irinotecan 150 mg m^-2 and docetaxel 60 mg m^-2 on day 1, and oxaliplatin 85 mg m^-2 on day 2. Cycles were repeated every 3 weeks. The primary end point was to demonstrate a 50% improvement in time-to-progression (TTP) over historical controls. All patients were evaluable. Median TTP was 6.5 months (95% confidence interval (CI) 5.6–7.4), the overall response rate was 50% (95% CI 35–65%) and the median overall survival was 11.5 months (95% CI 8.7–14.3). Grade 3/4 neutropaenia occurred in 47.5% of patients. There were four episodes of febrile neutropaenia in three patients. Other non-haematological grade 3 toxicities included diarrhoea in four patients (10%), vomiting in three patients (7.5%) and mucositis in two patients (5%). The irinotecan, docetaxel and oxaliplatin combination chemotherapy is an active and well-tolerated novel regimen for treating metastatic gastric or GEJ adenocarcinoma and deserves further evaluation in randomised trials and in combination with molecular targeting agents.