A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction

• Published in: Annals of oncology Vol. 21; no. 1; pp. 71 - 77
• Main Authors: Moehler, M., Kanzler, S., Geissler, M., Raedle, J., Ebert, M. P., Daum, S., Flieger, D., Seufferlein, T., Galle, P. R., Hoehler, T.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.01.2010
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Capecitabine; cisplatin; Cisplatin - administration & dosage; Cisplatin - adverse effects; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; elderly patients; Esophagogastric Junction - pathology; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; gastric cancer; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Irinotecan; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; capecitabine; elderly patients; irinotecan; gastric cancer; cisplatin; Adenocarcinoma; Antineoplastic agent; Capecitabine; Multicenter study; Metastasis; Stomach cancer; Randomization; Isomerases; Phase II trial; Advanced stage; Topoisomerase I inhibitor; Pyrimidine nucleoside; Gastric disease; Platinum II Complexes; Camptothecin derivatives; Human; Stomach; Digestive system; Enzyme; Fluoropyrimidine derivatives; DNA topoisomerase; Enzyme inhibitor; Patient; Malignant tumor; Prodrug; Cisplatin; Irinotecan; Alkylating agent; Treatment; Gastroesophageal junction; Digestive diseases; Elderly; Comparative study; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdp269

Background: The combination of irinotecan with 5-fluorouracil demonstrates efficacy with tolerable safety in the first-line treatment of metastatic gastroesophageal cancer (mGC). This randomized phase II trial compared for the first time capecitabine with irinotecan or cisplatin in this setting. Patients and methods: Patients were randomly assigned to receive 3-week cycles of capecitabine 1000 mg/m2, twice daily for 14 days, with on day 1 either irinotecan 250 mg/m2 (XI) or cisplatin 80 mg/m2 (XP). The primary end point was overall response rate (ORR) and secondary end points included progression-free survival (PFS), overall survival (OS) and safety. Results: Of 118 patients recruited, 112 were eligible for safety analysis and 103 for efficacy analysis. In the XI and XP treatment arms, there were no marked differences in ORR, 37.7% versus 42.0%, and median PFS, 4.2 versus 4.8 months, although median OS was longer, 10.2 versus 7.9 months, respectively. Grade 3/4 toxicity was higher in the XP regimen for thrombocytes (18.2% versus 1.8%), nausea (23.6% versus12.3%) and vomiting (16.4% versus 1.8%) and in the XI arm for diarrhea (22.8% versus 7.3%). Conclusion: The comparable activity and safety of the XI and XP regimens establish XI as a relevant platinum-free first-line treatment choice for patients with mGC.