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Phase II Study of Irinotecan plus S-1 Combination for Previously Untreated Advanced Non-Small Cell Lung Cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 0601

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Title: Phase II Study of Irinotecan plus S-1 Combination for Previously Untreated Advanced Non-Small Cell Lung Cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 0601
Authors: Akie, Kenji Browse this author
Oizumi, Satoshi Browse this author →KAKEN DB
Ogura, Shigeaki Browse this author
Shinagawa, Naofumi Browse this author
Kikuchi, Eiki Browse this author
Fukumoto, Shinichi Browse this author
Harada, Masao Browse this author
Kinoshita, Ichiro Browse this author
Kojima, Tetsuya Browse this author
Harada, Toshiyuki Browse this author
Fujita, Yuka Browse this author
Ohsaki, Yoshinobu Browse this author
Dosaka-Akita, Hirotoshi Browse this author
Isobe, Hiroshi Browse this author
Nishimura, Masaharu Browse this author
Keywords: Irinotecan
S-1
Chemotherapy
Nonplatinum regimens
Non-small cell lung cancer
phase II
Issue Date: Oct-2011
Publisher: Karger
Journal Title: Oncology
Volume: 81
Issue: 2
Start Page: 84
End Page: 90
Publisher DOI: 10.1159/000331681
Abstract: Objective: Platinum-free regimens can represent an alternative for advanced non-small cell lung cancer (NSCLC) if similar efficacy is provided with better tolerability. This study evaluated the efficacy and safety of combined irinotecan and S-1 for chemotherapy-naïve advanced NSCLC. Methods: Chemotherapy consisted of 4-week cycles of intravenous irinotecan (100 mg/m2, days 1 and 15) and oral S-1 (80 mg/m2, days 1-14). The primary endpoint was response rate, while secondary endpoints were overall survival (OS), progression-free survival (PFS), and safety. Results: A total of 112 cycles was administered to 40 patients (median, 3 cycles; range 1-6 cycles). Twelve patients showed partial response (PR) and 17 patients exhibited stable disease (SD), representing a response rate of 30% and a disease control rate of 72.5%. Median survival time and median PFS were 16.1 months and 4.8 months, respectively. Hematological toxicities of grade 3 or 4 were neutropenia (32.5%) and anemia (5.0%). The most common non-hematological toxicities of grade 3 or 4 included diarrhea (15.0%) and anorexia (17.5%). Patients homo- or heterozygous for UGTA1A*6 tended to show a higher incidence of grade 3 diarrhea (p = 0.055). Conclusion: The combination of irinotecan and S-1 offers good efficacy and tolerability for previously untreated advanced NSCLC.
Rights: © 2011 S. Karger AG, Basel
Type: article (author version)
URI: http://hdl.handle.net/2115/47435
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: 大泉 聡史

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