Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Br J Cancer. 2007 Sep 3;97(5):593-7. doi: 10.1038/sj.bjc.6603917. Epub 2007 Jul 31.

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Diarrhea / chemically induced
  • Disease Progression
  • Docetaxel
  • Esophagogastric Junction / drug effects*
  • Esophagogastric Junction / pathology
  • Female
  • Fever / chemically induced
  • Humans
  • Irinotecan
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Mucositis / chemically induced
  • Neoplasm Metastasis
  • Neutropenia / chemically induced
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Oxaliplatin
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Taxoids / administration & dosage
  • Taxoids / adverse effects
  • Treatment Outcome
  • Vomiting / chemically induced

Substances

  • Organoplatinum Compounds
  • Taxoids
  • Oxaliplatin
  • Docetaxel
  • Irinotecan
  • Camptothecin