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A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)

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Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/71783

Title: A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
Other Titles: A randomized phase II trial of erlotinib versus S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
Authors: Ikezawa, Yasuyuki Browse this author
Asahina, Hajime Browse this author →KAKEN DB
Oizumi, Satoshi Browse this author →KAKEN DB
Watanabe, Masahiro Browse this author
Takamura, Kei Browse this author
Kawai, Yasutaka Browse this author
Yamada, Noriyuki Browse this author
Harada, Toshiyuki Browse this author
Kinoshita, Ichiro Browse this author →KAKEN DB
Fujita, Yuka Browse this author
Miyauchi, Eisaku Browse this author
Ogi, Takahiro Browse this author
Amano, Toraji Browse this author
Furuta, Megumi Browse this author
Sakakibara-Konishi, Jun Browse this author →KAKEN DB
Nishihara, Hiroshi Browse this author →KAKEN DB
Dosaka-Akita, Hirotoshi Browse this author →KAKEN DB
Isobe, Hiroshi Browse this author →KAKEN DB
Nishimura, Masaharu Browse this author →KAKEN DB
Keywords: Erlotinib
S-1
Non-small cell lung cancer
Third-line therapy
Fourth-line therapy
Issue Date: Nov-2017
Publisher: Springer
Journal Title: Cancer chemotherapy and pharmacology
Volume: 80
Issue: 5
Start Page: 955
End Page: 963
Publisher DOI: 10.1007/s00280-017-3432-4
PMID: 28905108
Abstract: Purpose: A high proportion of patients with wild-type EGFR non-small cell lung cancer (NSCLC) receive third-line therapy and beyond, with no prospective randomized trials addressing the issue. This study aimed to select the most suitable regimen as a third- or fourth-line therapy for wild-type EGFR NSCLC. Methods: This multicenter, randomized phase II study in Japan included patients with recurrent or advanced NSCLC with wild-type or unknown EGFR, who progressed after two or three previous chemotherapies. The patients were randomly assigned to erlotinib (150 mg/day, days 1-21) or S-1 (80-120 mg/day, days 1-14) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), toxicity, and quality of life (QOL). Results: From 2011 to 2016, 37 patients were randomly assigned to receive erlotinib (E arm, n = 19) and S-1 (S arm, n = 18). This study was terminated prematurely because of poor patient accrual. DCR/ORR were 42.1%/15.8% in the E arm and 66.7%/16.7% in the S arm. Median PFS/OS were 1.6 months/8.0 months in the E arm and 3.3 months/12.2 months in the S arm. In both groups, the most commonly reported grade 3-4 toxicities were fatigue, anorexia, and nausea. One grade 5 pneumonitis occurred in the S arm. No significant difference was seen in QOL. Conclusions: S-1 as a third- or fourth-line therapy for wild-type EGFR NSCLC showed numerically better clinical outcomes than erlotinib. Clinical trial registration no. UMIN000005308.
Rights: The final publication is available at link.springer.com
Type: article (author version)
URI: http://hdl.handle.net/2115/71783
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: 朝比奈 肇

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