RT Journal Article SR Electronic T1 Multicenter Phase II Study of Irinotecan Plus Bolus Fluorouracil/l-Leucovorin for Metastasic Colorectal Cancer JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 1003 OP 1008 VO 27 IS 2 A1 MISHIMA, HIDEYUKI A1 IKENAGA, MASAKAZU A1 ISHIDA, HIDEYUKI A1 IWAMOTO, SHIGENORI A1 MORIMOTO, TAKASHI A1 NARAHARA, HIROYUKI A1 KATO, TAKESHI A1 TSUJIE, MASAKI A1 KITAI, TOSHIYUKI A1 FUKUNAGA, MUTSUMI A1 NAKANISHI, MASAYOSHI A1 TSUJINAKA, TOSHIMASA A1 FURUKAWA, HIROSHI A1 TAGUCHI, TETSUO A1 OSAKA GASTROINTESTINAL CANCER CHEMOTHERAPY STUDY GROUP YR 2007 UL http://ar.iiarjournals.org/content/27/2/1003.abstract 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