Multicenter phase II study of irinotecan plus bolus fluorouracil/l-leucovorin for metastasic colorectal cancer.
Treatment of metastatic colorectal cancer remains inadequate.


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.


CONCLUSIONS
Irinotecan plus 5-FU/l-LV can be used to treat metastatic colorectal cancer on an outpatient basis.
Mishima
Hideyuki
H
Department of Gastroenterogical Surgery, Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka 540-0006, Japan. hmishima@onh.go.jp
Ikenaga
Masakazu
M
Ishida
Hideyuki
H
Iwamoto
Shigenori
S
Morimoto
Takashi
T
Narahara
Hiroyuki
H
Kato
Takeshi
T
Tsujie
Masaki
M
Kitai
Toshiyuki
T
Fukunaga
Mutsumi
M
Nakanishi
Masayoshi
M
Tsujinaka
Toshimasa
T
Furukawa
Hiroshi
H
Taguchi
Tetsuo
T
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis
D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin