PT - JOURNAL ARTICLE AU - MISHIMA, HIDEYUKI AU - IKENAGA, MASAKAZU AU - ISHIDA, HIDEYUKI AU - IWAMOTO, SHIGENORI AU - MORIMOTO, TAKASHI AU - NARAHARA, HIROYUKI AU - KATO, TAKESHI AU - TSUJIE, MASAKI AU - KITAI, TOSHIYUKI AU - FUKUNAGA, MUTSUMI AU - NAKANISHI, MASAYOSHI AU - TSUJINAKA, TOSHIMASA AU - FURUKAWA, HIROSHI AU - TAGUCHI, TETSUO AU - OSAKA GASTROINTESTINAL CANCER CHEMOTHERAPY STUDY GROUP TI - Multicenter Phase II Study of Irinotecan Plus Bolus Fluorouracil/<em>l</em>-Leucovorin for Metastasic Colorectal Cancer DP - 2007 Mar 01 TA - Anticancer Research PG - 1003--1008 VI - 27 IP - 2 4099 - http://ar.iiarjournals.org/content/27/2/1003.short 4100 - http://ar.iiarjournals.org/content/27/2/1003.full SO - Anticancer Res2007 Mar 01; 27 AB - Treatment of metastatic colorectal cancer remains inadequate. Patients and Methods: In a multicentre Phase II study, irinotecan (100 mg/m2), 5-fluorouracil (5-FU) (500 mg/m2), and l-leucovorin (l-LV) (250 mg/m2) were administered on days 1, 8, and 15 of a five-week cycle. Forty-five patients were enrolled. Results: The objective response rate was 26.7%. The median survival time was 21.8 months and the one-year survival rate was 73.3%. The median number of cycles was 4.0, with a median relative dose intensity of 83.3% for both irinotecan and 5-FU. Grade 3 or 4 haematological toxicities were anaemia in four patients, leukopaenia in six patients, and neutropaenia in 15 patients, while non-haematological toxicities were diarrhoea in three patients, and nausea, vomiting, anorexia and increased transaminases in two patients each. No treatment-related deaths occurred. Conclusion: Irinotecan plus 5-FU/l-LV can be used to treat metastatic colorectal cancer on an outpatient basis. Copyright© 2007 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved