Randomized Phase III Study Comparing Gefitinib With Erlotinib in Patients With Previously Treated Advanced Lung Adenocarcinoma: WJOG 5108L

  • Yoshiko Urata
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Nobuyuki Katakami
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Satoshi Morita
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Reiko Kaji
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Hiroshige Yoshioka
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Takashi Seto
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Miyako Satouchi
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Yasuo Iwamoto
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Masashi Kanehara
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Daichi Fujimoto
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Norihiko Ikeda
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Haruyasu Murakami
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Haruko Daga
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Tetsuya Oguri
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Isao Goto
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Fumio Imamura
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Shunichi Sugawara
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Hideo Saka
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Naoyuki Nogami
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Shunichi Negoro
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Kazuhiko Nakagawa
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...
  • Yoichi Nakanishi
    Yoshiko Urata, Miyako Satouchi, and Shunichi Negoro, Hyogo Cancer Center, Akashi; Nobuyuki Katakami and Reiko Kaji, Institute of Biomedical Research and Innovation; Daichi Fujimoto, Kobe City Medical Center General Hospital, Kobe; Satoshi Morita, Kyoto University Graduate School of Medicine, Kyoto; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Takashi Seto, National Kyushu Cancer Center; Yoichi Nakanishi, Kyushu University, Graduate School of Medical Sciences, Fukuoka; Yasuo Iwamoto and...

抄録

<jats:sec><jats:title>Purpose</jats:title><jats:p> The epidermal growth factor receptor (EGFR) tyrosine kinase has been an important target for non–small-cell lung cancer. Several EGFR tyrosine kinase inhibitors (TKIs) are currently approved, and both gefitinib and erlotinib are the most well-known first-generation EGFR-TKIs. This randomized phase III study was conducted to investigate the difference between these two EGFR-TKIs. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Previously treated patients with lung adenocarcinoma were randomly assigned to receive gefitinib or erlotinib. This study aimed to investigate the noninferiority of gefitinib compared with erlotinib. The primary end point was progression-free survival (PFS). </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Five hundred sixty-one patients were randomly assigned, including 401 patients (71.7%) with EGFR mutation. All baseline factors (except performance status) were balanced between the arms. Median PFS and overall survival times for gefitinib and erlotinib were 6.5 and 7.5 months (hazard ratio [HR], 1.125; 95% CI, 0.940 to 1.347; P = .257) and 22.8 and 24.5 months (HR, 1.038; 95% CI, 0.833 to 1.294; P = .768), respectively. The response rates for gefitinib and erlotinib were 45.9% and 44.1%, respectively. Median PFS times in EGFR mutation–positive patients receiving gefitinib versus erlotinib were 8.3 and 10.0 months, respectively (HR, 1.093; 95% CI, 0.879 to 1.358; P = .424). The primary grade 3 or 4 toxicities were rash (2.2% for gefitinib v 18.1% for erlotinib) and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation (6.1%/13.0% for gefitinib v 2.2%/3.3% for erlotinib). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The study did not demonstrate noninferiority of gefitinib compared with erlotinib in terms of PFS in patients with lung adenocarcinoma according to the predefined criteria. </jats:p></jats:sec>

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