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タイトル
  • en 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)
その他のタイトル
  • en 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)
作成者
    • en Ikezawa, Yasuyuki
    • en Watanabe, Masahiro
    • en Takamura, Kei
    • en Kawai, Yasutaka
    • en Yamada, Noriyuki
    • en Harada, Toshiyuki
    • en Fujita, Yuka
    • en Miyauchi, Eisaku
    • en Ogi, Takahiro
    • en Amano, Toraji
    • en Furuta, Megumi
アクセス権 open access
権利情報
  • en The final publication is available at link.springer.com
主題
  • Other en Erlotinib
  • Other en S-1
  • Other en Non-small cell lung cancer
  • Other en Third-line therapy
  • Other en Fourth-line therapy
  • NDC 490
内容注記
  • Abstract en 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.
出版者 en Springer
日付
    Issued2017-11
言語
  • eng
資源タイプ journal article
出版タイプ AM
資源識別子 HDL http://hdl.handle.net/2115/71783
関連
  • isVersionOf DOI https://doi.org/10.1007/s00280-017-3432-4
  • PMID 28905108
収録誌情報
    • PISSN 0344-5704
      • en Cancer chemotherapy and pharmacology
      • 巻80 号5 開始ページ955 終了ページ963
ファイル
コンテンツ更新日時 2023-07-26