[Modified FOLFIRI (l-LV, 5-fluorouracil and irinotecan) therapy for Japanese patients with metastatic colorectal cancer].
OBJECTIVE
As a project of the Kanagawa Colorectal Cancer Study Group, we performed this study to analyze the efficacy and the safety of modified FOLFIRI (irinotecan: 150 mg/m2) therapy for Japanese patients with metastatic colorectal cancer.


METHODS
We treated PS 0-1 Japanese patients with measurable or assessable colorectal cancer who either had not received preliminary treatment, or were postoperative with metastasis and had undergone radiation therapy or adjuvant chemotherapy before more than four weeks, and further had provided written acceptance of our proposed procedures. Twenty patients received modified FOLFIRI therapy as a 2-hour infusion of CPT-11 150 mg/m/2 and l-LV 200 mg/m2 followed by a bolus 5-FU 400 mg/m/2 and 46-hour infusion 5-FU 2, 400 mg/m2. Tumor response was assessed by RECIST and toxicity by NCI-CTC.


RESULTS
Thirty males and seven females underwent an average 10 courses of treatment. This therapy achieved a 50% response rate, 80%disease-control rate, and 316+/-40 days PHS. Regarding hematological toxicity, 11 patients (55%) experienced leukemia, which developed to grade 3/4 in 5 (25%) of them. Twelve patients (65%) experienced neutropenia, which developed to grade 3/4 in 10 (50%) of them. Digestive toxicity was observed in 16 patients (80%), which developed to grade 3/4 in only one patient (5%) with gastric ulcer. Six patients (30%) experienced alopecia, which was grade 1/2 only.


CONCLUSIONS
This clinical study was safely carried out. The efficacy was as good as in previous reports using a regular dose of CPT-11.
Yukawa
Norio
N
Department of Surgery, Yokohama City University, Yokohama City University Hospital.
Yamamoto
Yuji
Y
Akaike
Makoto
M
Shiozawa
Manabu
M
Takahashi
Makoto
M
Shiraishi
Ryuji
R
Matsukawa
Hiroshi
H
Suzuki
Hiroharu
H
Tamura
Isao
I
Ozawa
Yukihiro
Y
Yamamoto
Naoto
N
Rino
Yasushi
Y
Masuda
Munetaka
M
Imada
Toshio
T
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D015996:Survival Rate
D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin