Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer

Riichiroh Maruyama, Yutaka Nishiwaki, Tomohide Tamura, Nobuyuki Yamamoto, Masahiro Tsuboi, Kazuhiko Nakagawa, Tetsu Shinkai, Shunichi Negoro, Fumio Imamura, Kenji Eguchi, Koji Takeda, Akira Inoue, Keisuke Tomii, Masao Harada, Noriyuki Masuda, Haiyi Jiang, Yohji Itoh, Yukito Ichinose, Nagahiro Saijo, Masahiro Fukuoka

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356 Citations (Scopus)


Purpose: This phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m2) In patients (N = 489) with advanced/metastatic non - small-cell lung cancer (NSCLC) who had failed one or two chemotherapy regimens. Methods:The primary objective was to compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. An unadjusted Cox regression model was used for the primary analysis. Results:Noninferiority in overall survival was not achieved (hazard ratio [HR], 1.12; 95.24% Cl, 0.89 to 1.40) according to the predefined criterion (upper Cl limit for HR ≤ 1.25); however, no significant difference in overall survival (P = .330) was apparent between treatments. Poststudy, 36% of gefitinib-treated patients received subsequent docetaxel, and 53% of docetaxel-treated patients received subsequent gefitinib. Gefitinib significantly improved objective response rate and quality of life versus docetaxel; progression-free survival, disease control rates, and symptom mprovement were similar for the two treatments. Grades 3 to 4 adverse events occurred in 40.6% (gefitinib) and 81.6% (docetaxel) of patients. Incidence of interstitial lung disease was 5.7% (gefitinib) and 2.9% (docetaxel). Four deaths occurred due to adverse events in the gefitinib arm (three deaths as a result of interstitial lung disease, judged to be treatment related; one as a result of pneumonia, not treatment related), and none occurred in the docetaxel arm. Conclusion:Noninferiority in overall survival between gefitinib and docetaxel was not demonstrated according to predefined criteria; however, there was no statistically significant difference in overall survival. Secondary end points showed similar or superior efficacy for gefitinib compared with docetaxel. Gefitinib remains an effective treatment option for previously treated Japanese patients with NSCLC.

Original languageEnglish
Pages (from-to)4244-4252
Number of pages9
JournalJournal of Clinical Oncology
Issue number26
Publication statusPublished - 2008 Sept 10


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