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Medline ® Abstract for Reference 26

of 'Systemic therapy for advanced non-small cell lung cancer with an activating mutation in the epidermal growth factor receptor'

Randomized Phase III Study Comparing Gefitinib With Erlotinib in Patients With Previously Treated Advanced Lung Adenocarcinoma: WJOG 5108L.
Urata Y, Katakami N, Morita S, Kaji R, Yoshioka H, Seto T, Satouchi M, Iwamoto Y, Kanehara M, Fujimoto D, Ikeda N, Murakami H, Daga H, Oguri T, Goto I, Imamura F, Sugawara S, Saka H, Nogami N, Negoro S, Nakagawa K, Nakanishi Y
J Clin Oncol. 2016;34(27):3248.
PURPOSE: 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.
PATIENTS AND METHODS: 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).
RESULTS: 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).
CONCLUSION: 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.
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, Hiroshima City Hospital, Hiroshima; Norihiko Ikeda, Tokyo Medical University, Tokyo; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Haruko Daga, Osaka City General Hospital; Fumio Imamura, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Isao Goto, Osaka Medical College, Takatsuki; Hideo Saka, National Hospital Organization Nagoya Medical Center; Tetsuya Oguri, Nagoya City University Graduate School of Medical Sciences, Nagoya; Shunichi Sugawara, Sendai Kousei Hospital, Sendai; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Kazuhiko Nakagawa, Kinki University Faculty of Medicine, Osaka-Sayama, Japan. urata@hp.pref.hyogo.jp.