Multicenter phase II study of oral capecitabine plus irinotecan as first-line chemotherapy in advanced colorectal cancer: a Korean Cancer Study Group trial.

Abstract	A phase II study was conducted to assess the efficacy and tolerability of capecitabine in combination with irinotecan (CAPIRI) in advanced colorectal cancer. Forty-seven patients with previously untreated metastatic or unresectable colorectal adenocarcinoma received capecitabine 1000 mg/m2 twice daily on days 2-15 and intravenous irinotecan 100 mg/m2 on days 1 and 8, every 21 days. A total of 268 cycles of chemotherapy (median 6: range 1-11) were administered. According to an intent-to-treat analysis, the overall response rate was 49% (95% CI, 35-63%). Median time to progression and overall survival were 7.5 months (95% CI, 4.8-10.2) and 19.5 months (95% CI, 15.7-23.8), respectively. The most common grade 3/4 adverse events were diarrhea (24%) and neutropenia (11%). There were no treatment-related deaths. These results indicate that CAPIRI has comparable activity and tolerability to FOLFIRI as first-line treatment for advanced colorectal cancer.
Authors	Tae Won Kim, Won Ki Kang, Heung Moon Chang, Joon Oh Park, Baek Yeol Ryoo, Jin Seok Ahn, Dae Young Zang, Kyung Hee Lee, Yoon Koo Kang, Sung Rok Kim, Hoon-Kyo Kim, Korean Cancer Study Group
Journal	Acta oncologica (Stockholm, Sweden) (Acta Oncol) Vol. 44 Issue 3 Pg. 230-5 ( 2005) ISSN: 0284-186X [Print] England
PMID	16076694 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)
Chemical References	Antimetabolites, Antineoplastic Antineoplastic Agents, Phytogenic Prodrugs Topoisomerase I Inhibitors Deoxycytidine Capecitabine Irinotecan Fluorouracil Camptothecin
Topics	Adenocarcinoma (drug therapy, secondary) Adult Aged Antimetabolites, Antineoplastic (administration & dosage) Antineoplastic Agents, Phytogenic (administration & dosage) Antineoplastic Combined Chemotherapy Protocols (therapeutic use) Camptothecin (administration & dosage, analogs & derivatives) Capecitabine Colonic Neoplasms (drug therapy) Deoxycytidine (administration & dosage, analogs & derivatives) Diarrhea (chemically induced) Disease Progression Female Fluorouracil (analogs & derivatives) Follow-Up Studies Humans Irinotecan Male Middle Aged Neutropenia (chemically induced) Prodrugs (administration & dosage) Rectal Neoplasms (drug therapy) Remission Induction Survival Rate Topoisomerase I Inhibitors Treatment Outcome

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