Multicenter phase II study of irinotecan plus bolus fluorouracil/l-leucovorin for metastasic colorectal cancer
Mishima, H.; Ikenaga, M.; Ishida, H.; Iwamoto, S.; Morimoto, T.; Narahara, H.; Kato, T.; Tsujie, M.; Kitai, T.; Fukunaga, M.; Nakanishi, M.; Tsujinaka, T.; Furukawa, H.; Taguchi, T.
Anticancer Research 27(2): 1003-1008
2007
ISSN/ISBN: 0250-7005 PMID: 17465234 Document Number: 610620
Treatment of metastatic colorectal cancer remains inadequate. Patients and Methods: In a multicentre Phase II study, irinotecan (100 mg/m(2)), 5-fluorouracil (5-FU) (500 mg/m(2)), and I-leucovorin (l-LV) (256 mg/m(2)) 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.