title: A phase II study of irinotecan in combination with doxifluridine, an intermediate form of capecitabine, in patients with metastatic colorectal cancer.
abstract: The purpose of this study was to examine the efficacy of a combination treatment of sequential irinotecan and doxifluridine, an intermediate of capecitabine, evaluated by the response rate and safety in patients with metastatic colorectal cancer. In all, 60 metastatic colorectal cancer patients with measurable disease were enrolled. The schedule of the treatment consisted of a 90 min intravenous (IV) infusion of irinotecan 150 mg/m2 for on days 1 and 15, and 600-1,000 mg/body of oral doxifluridine on days 3-14 and 17-28. Cycles were repeated every 35 days. A median of three cycles of the combination therapy (range 1-14 cycles) was administered. A total of 57 patients (95%) completed at least two cycles of the therapy without any dose reductions. There was one complete response and 23 partial responses with an overall response rate of 40% [95% confidence interval (CI): 28-53%]. A total of 19 patients had stable disease, 43(72%) achieved disease control. The median time to progression was 5.9 months and the median overall survival was 20.5 months. Ten (17%) and 17 (28%) patients developed Grade 3-4 leukopenia and neutropenia, respectively. Grade 3-4 fatigue was observed in 7(12%) patients, nausea in five (8%), vomiting in four (7%), and diarrhea,in three (5%) patients. No treatment-related deaths were noted during the study. From these results, the combination of sequential irinotecan and doxifluridine is considered to be an effective, easy-to-administer regimen with acceptable tolerability.
authors: Minoh City Hospital, 5-7-1 Kayano, Minoh City, Osaka 562-8562, Japan. takeshi_kato@maple.city.minoh.lg.jp
authors: Takeshi
authors: T
authors: Kato
authors: Hideyuki
authors: H
authors: Mishima
authors: Masakazu
authors: M
authors: Ikenaga
authors: Kouhei
authors: K
authors: Murata
authors: Hideyuki
authors: H
authors: Ishida
authors: Mutsumi
authors: M
authors: Fukunaga
authors: Hirofumi
authors: H
authors: Ota
authors: Shusei
authors: S
authors: Tominaga
authors: Tadashi
authors: T
authors: Ohnishi
authors: Masahiro
authors: M
authors: Amano
authors: Kimimasa
authors: K
authors: Ikeda
authors: Masataka
authors: M
authors: Ikeda
authors: Mitsugu
authors: M
authors: Sekimoto
authors: Junichi
authors: J
authors: Sakamoto
authors: Morito
authors: M
authors: Monden
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000097:blood / Q000139:chemically induced; D006801:Humans; D000077146:Irinotecan; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D018401:Sample Size; D016019:Survival Analysis
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D005467:Floxuridine; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; C025034:doxifluridine; D002166:Camptothecin