title: Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer.
abstract: OBJECTIVE
  This phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m(2)) 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 <or= 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Riichiroh
authors.initials: R
authors.lastname: Maruyama
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Tetsu
authors.initials: T
authors.lastname: Shinkai
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Keisuke
authors.initials: K
authors.lastname: Tomii
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Masuda
authors.forename: Haiyi
authors.initials: H
authors.lastname: Jiang
authors.forename: Yohji
authors.initials: Y
authors.lastname: Itoh
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011799:Quinazolines / Q000627:therapeutic use*; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; D000077156:Gefitinib