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Vol.49 No.6 contents | Japanese/English |
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- The 23rd Lung Cancer Workshop -
V15-32 and INTEREST
Seiji Niho11Division of Thoracic Oncology, National Cancer Center Hospital East, Japan
Objective. Two randomized trials (INTEREST and V15-32) were conducted to compare gefitinib with docetaxel on overall survival in patients with pretreated advanced non-small cell lung cancer (NSCLC) with the aim of demonstrating non-inferiority. Methods. Patients with advanced NSCLC who failed 1 or 2 chemotherapy regimens including platinum were randomized to gefitinib (250 mg/day) or docetaxel (75 mg/m2 in INTEREST, 60 mg/m2 in V15-32, every 3 weeks). Results. We registered 1466 and 489 eligible patients in INTEREST and V15-32, respectively. Non-inferiority in overall survival was achieved (hazard ratio (HR) 1.020; 96% confidence interval (CI) 0.905, 1.150) according to a predefined criterion (upper CI limit for HR<1.154) in INTEREST. On the other hand, non-inferiority was not achieved (HR 1.12; 95.24% CI 0.89, 1.40) according to a predefined criterion (upper CI limit for HR<1.25) in V15-32. Gefitinib significantly improved overall response rate in V15-32 (22.5% vs 12.8%; p=0.009). Incidence of interstitial lung disease was 5.7% (n=14) and 2.9% (n=7), respectively in V15-32. Conclusion. Non-inferiority in overall survival between gefitinib and docetaxel was demonstrated in INTEREST.
key words: Gefitinib, Docetaxel, Non-small cell lung cancer, Overall survival, Non-inferiority
JJLC 49 (6): 944-949, 2009
