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

• Published in: British journal of cancer Vol. 97; no. 5; pp. 593 - 597
• Main Authors: DI LAURO, L, NUNZIATA, C, ARENA, M. G, FOGGI, P, SPERDUTI, I, LOPEZ, M
• Format: Journal Article
• Language: English
• Published: Basingstoke Nature Publishing Group 28.08.2007
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Clinical Study; Diarrhea - chemically induced; Disease Progression; Docetaxel; Esophagogastric Junction - drug effects; Esophagogastric Junction - pathology; Female; Fever - chemically induced; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Irinotecan; Kaplan-Meier Estimate; Male; Medical sciences; 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; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Taxoids - administration & dosage; Taxoids - adverse effects; Treatment Outcome; Tumors; Vomiting - chemically induced; Antineoplastic agent; Drug combination; Enzyme; DNA topoisomerase; Docetaxel; Enzyme inhibitor; metastatic gastric cancer; Malignant tumor; Metastasis; Stomach adenocarcinoma; Stomach cancer; Irinotecan; Alkylating agent; Isomerases; Cancerology; Oxaliplatin; Gastroesophageal junction; Taxane derivatives; Digestive diseases; Advanced stage; Antimitotic; Gastric disease; Platinum II Complexes
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6603917

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.