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- Title
Phase I study of preoperative chemoradiotherapy with sequential oxaliplatin and irinotecan with S-1 for locally advanced rectal cancer.
- Authors
Fujikawa, Hiroyuki; Toiyama, Yuji; Inoue, Yasuhiro; Omura, Yusuke; Ide, Shozo; Kitajima, Takahito; Yasuda, Hiromi; Okugawa, Yoshinaga; Okita, Yoshiki; Yoshiyama, Shigeyuki; Hiro, Junichiro; Kobayashi, Minako; Ohi, Masaki; Araki, Toshimitsu; Kusunoki, Masato
- Abstract
The present study designed a novel preoperative chemoradiotherapy (CRT) with sequential oxaliplatin and irinotecan with S-1 for locally advanced rectal cancer (LARC). This phase I study evaluated the maximum tolerated dose and recommended dose (RD) of oxaliplatin following irinotecan with S-1. Patients with clinical stage T3 or 4 or involvement of the regional nodes and no evidence of distant metastases were treated with fixed doses of S-1 (80 mg/m2/day) on days 1–5, 8–12, 15–19, 22–27 and 29–33, and irinotecan (40 mg/m2/day) on days 1 and 8, followed by oxaliplatin on days 22 and 29. The dose of oxaliplatin was initially 40 mg/m2 (level 1) with a predefined dose escalation schedule. The radiation dose was 1.8 Gy/fraction to a total dose of 45 Gy. A total of 9 patients were enrolled in the present study and 7 patients completely received CRT with this study protocol. The maximum tolerated dose for oxaliplatin was 50 mg/m2 (level 2). Three of four patients experienced dose-limiting toxicity (grade 3 diarrhea) in oxaliplatin phase of level 2 dose. The RD of oxaliplatin was 40 mg/m2 (level 1 dose). In addition, 2 patients had pathological CR (28.5%). Novel preoperative CRT with sequential oxaliplatin and irinotecan with S-1 for LARC resulted in acceptable toxicity and promising efficacy. However, the RD of oxaliplatin was lower than in previous CRT studies that combined oxaliplatin with S-1. To administer higher oxaliplatin, we have planned a phase I trial of preoperative CRT with sequential oxaliplatin followed by irinotecan with S-1 for LARC.
- Subjects
RECTAL cancer; OXALIPLATIN; CHEMORADIOTHERAPY; RADIATION doses
- Publication
Oncology Letters, 2019, Vol 17, Issue 4, p3930
- ISSN
1792-1074
- Publication type
Article