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Randomized 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)

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Title: Randomized 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)
Authors: Komatsu, Yoshito Browse this author →KAKEN DB
Takahashi, Yutaka Browse this author
Kimura, Yutaka Browse this author
Oda, Hisashi Browse this author
Tajima, Yusuke Browse this author
Tamura, Shigeyuki Browse this author
Sakurai, Jo Browse this author
Wakasugi, Takehiro Browse this author
Tatebe, Shigeru Browse this author
Takahashi, Masahiro Browse this author
Sakata, Yuh Browse this author
Kitajima, Masaki Browse this author
Sakamoto, Junichi Browse this author
Saji, Shigetoyo Browse this author
Keywords: gastric cancer
irinotecan
S-1
tailored chemotherapy
Issue Date: Jul-2011
Publisher: Lippincott Williams & Wilkins
Journal Title: Anti-Cancer Drugs
Volume: 22
Issue: 6
Start Page: 576
End Page: 583
Publisher DOI: 10.1097/CAD.0b013e328345b509
PMID: 21512394
Abstract: Objective: 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.
Rights: This is a non-final version of an article published in final form in Anti-Cancer Drugs, Jul 2011, 22(6), 576-583
Relation: http://journals.lww.com/anti-cancerdrugs/pages/default.aspx
Type: article (author version)
URI: http://hdl.handle.net/2115/49475
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小松 嘉人

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