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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

From the National Kyushu Cancer Center, Fukuoka; National Cancer Center Hospital East, Chiba; National Cancer Center Hospital; Tokyo Medical University Hospital, Tokyo; Shizuoka Cancer Center, Shizuoka; Kinki University School of Medicine; Osaka Medical Center for Cancer and Cardiovascular Diseases; Osaka City General Hospital; AstraZeneca KK, Osaka; Shikoku Cancer Center, Ehime; Hyogo Medical Center for Adults; Kobe City General Hospital, Hyogo; Tokai University Hospital, Kanagawa; Tohoku University Hospital, Miyagi; Hokkaido Cancer Center, Hokkaido; and Kitasato University School of Medicine, Kanagawa, Japan

Corresponding author: Yukito Ichinose, MD, Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1 Notame Minami-ku, Fukuoka, 811-1395, Japan; e-mail: yichinos{at}nk-cc.go.jp

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% CI, 0.89 to 1.40) according to the predefined criterion (upper CI 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 improvement 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.

Supported by AstraZeneca.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00252707 [ClinicalTrials.gov] .

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