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)
|