A phase II study of combination therapy with irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer.
OBJECTIVE
A combination of irinotecan with continuous infusional 5-fluorouracil (5-FU) is the standard treatment for advanced colorectal cancer. The aim of this study was to determine the efficacy and safety of combining irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer.


METHODS
Irinotecan was administered as an intravenous infusion at a dose of 120 mg/m(2) on day 1 and 15. And S-1 was administered orally on days 1-14 of a 28-day cycle. S-1 was given orally at a dose that did not exceed 40 mg/m(2) based BSA: BSA < 1.25 m(2), 40 mg twice daily; 1.25-1.5 m(2), 50 mg twice daily, and BSA > 1.5 m(2), 60 mg twice daily, for 14 consecutive days.


RESULTS
A total of 38 patients were enrolled. An intent-to-treat analysis showed a complete response and partial response to occur in 13.2% and 50.0%, respectively. The disease control rate was 84.2%. The median progression-free survival and overall survival were 10.0 months and 29.1 months, respectively. The rates of grade 3/4 toxicity over 4 cycles were the following: neutropenia, 15.8%; leucopenia, 7.9%; anorexia, 15.8%; diarrhea, 10.5%.


CONCLUSIONS
IRIS is an effective, well tolerated and convenient treatment regimen for patients with advanced colorectal cancer.
Shiozawa
Manabu
M
Department of Gastrointestinal Sugery, Kanagawa Cancer Center, Asahi-ku, Yokohama, Japan. shioz@coral.ocn.ne.jp
Akaike
Makoto
M
Sugano
Nobuhiro
N
Tsuchida
Kazuhito
K
Yamamoto
Naoto
N
Morinaga
Soichiro
S
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001830:Body Surface Area; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D013534:Survival; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin