2024-03-28T12:56:25Zhttps://eprints.lib.hokudai.ac.jp/dspace-oai/requestoai:eprints.lib.hokudai.ac.jp:2115/494752022-11-17T02:08:08Zhdl_2115_20043hdl_2115_137Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)Komatsu, YoshitoTakahashi, YutakaKimura, YutakaOda, HisashiTajima, YusukeTamura, ShigeyukiSakurai, JoWakasugi, TakehiroTatebe, ShigeruTakahashi, MasahiroSakata, YuhKitajima, MasakiSakamoto, JunichiSaji, Shigetoyogastric canceririnotecanS-1tailored chemotherapy494Objective: The pharmacokinetics of irinotecan vary markedly between individuals. This study sought to compare tailored irinotecan and S-1 therapy with S-1 monotherapy for the treatment of patients with advanced/recurrent gastric cancer. Methods: Patients with advanced/recurrent gastric cancer were randomized to receive tailored irinotecan and S-1 (arm A) or S-1 alone (arm B). Arm A received S-1 (80-120 mg/m2/day) for 14 days, with irinotecan on days 1 and 15. The initial irinotecan dose of 75 mg/m2 (level 0) was adjusted for toxicity during the previous course. In arm B, S-1 (80-120 mg/day) was administered alone for 28 days, followed by 14 days without therapy. Results: Ninety-five patients were randomized (48 to arm A and 47 to arm B). The response rate of the primary tumor (Japanese criteria) was 25.0% in arm A (12/48) and 14.9% in arm B (7/47), whereas the response rates according to Response Evaluation Criteria In Solid Tumors (RECIST) were 27.8% (10/36) versus 21.9% (7/32). Hematological toxicity, anorexia, and diarrhea were significantly more common in arm A, but both arms had similar grade 3-4 toxicities. Conclusion: These findings suggest the usefulness of tailored irinotecan plus S-1 therapy for gastric cancer.Lippincott Williams & WilkinsJournal Articleapplication/pdfhttp://hdl.handle.net/2115/49475https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/49475/1/ACD22-6_576-583.pdf0959-4973Anti-Cancer Drugs2265765832011-07enginfo:pmid/21512394info:doi/10.1097/CAD.0b013e328345b509This is a non-final version of an article published in final form in Anti-Cancer Drugs, Jul 2011, 22(6), 576-583author