OBJECTIVES: This phase II study was designed to evaluate the efficacy and safety of oral fluoropyrimidine S-1 plus irinotecan (IRIS regimen) in patients with previously untreated metastatic colorectal cancer. METHODS: The response rate was the primary endpoint. Safety, progression-free survival time, and median survival time were secondary endpoints. The subjects were untreated patients with inoperable advanced colorectal cancer. Irinotecan was administered at a dose of 100 mg/m² (on days 1 and 15). S-1 (40 mg/m²) was administered for 2 weeks (on days 1 to 14) and followed by a 2-week rest. RESULTS: Forty patients were enrolled. Four patients had grade 4 neutropenia, and six patients had grade 3 diarrhea. No other serious hematologic or nonhematologic adverse reactions occurred, and all patients received IRIS safely on an outpatient basis. The response rate was 52.5% (95% confidence interval [CI], 36.1-68.5%). Median progression-free survival was 8.6 months (95% CI, 5.3-11.9), and median survival time was 23.4 months (95% CI, 15.9-30.8). CONCLUSIONS: IRIS produced a high response rate and could be given safely. IRIS may become a first-line treatment for inoperable or recurrent advanced colorectal cancer.
OBJECTIVES: This phase II study was designed to evaluate the efficacy and safety of oral fluoropyrimidineS-1 plus irinotecan (IRIS regimen) in patients with previously untreated metastatic colorectal cancer. METHODS: The response rate was the primary endpoint. Safety, progression-free survival time, and median survival time were secondary endpoints. The subjects were untreated patients with inoperable advanced colorectal cancer. Irinotecan was administered at a dose of 100 mg/m² (on days 1 and 15). S-1 (40 mg/m²) was administered for 2 weeks (on days 1 to 14) and followed by a 2-week rest. RESULTS: Forty patients were enrolled. Four patients had grade 4 neutropenia, and six patients had grade 3 diarrhea. No other serious hematologic or nonhematologic adverse reactions occurred, and all patients received IRIS safely on an outpatient basis. The response rate was 52.5% (95% confidence interval [CI], 36.1-68.5%). Median progression-free survival was 8.6 months (95% CI, 5.3-11.9), and median survival time was 23.4 months (95% CI, 15.9-30.8). CONCLUSIONS: IRIS produced a high response rate and could be given safely. IRIS may become a first-line treatment for inoperable or recurrent advanced colorectal cancer.
Authors: W Ichikawa; K Uehara; K Minamimura; C Tanaka; Y Takii; H Miyauchi; S Sadahiro; K Fujita; T Moriwaki; M Nakamura; T Takahashi; A Tsuji; K Shinozaki; S Morita; Y Ando; Y Okutani; M Sugihara; T Sugiyama; Y Ohashi; Y Sakata Journal: Br J Cancer Date: 2015-04-16 Impact factor: 7.640
Authors: T Ioka; Y Komatsu; N Mizuno; A Tsuji; S Ohkawa; M Tanaka; H Iguchi; A Ishiguro; M Kitano; T Satoh; T Yamaguchi; K Takeda; M Kida; K Eguchi; T Ito; M Munakata; T Itoi; J Furuse; C Hamada; Y Sakata Journal: Br J Cancer Date: 2017-01-12 Impact factor: 7.640