FIRST LINE GEFITINIB THERAPY FOR NSCLC

N Engl J Med. 2009 Aug 19. [Epub ahead of print]

Related Articles, Links

Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma.

Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M.

From the State Key Laboratory in Oncology in South China, Sir YK Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), Guangdong General Hospital, Guangzhou (Y-L.W., J.-J.Y.), Cancer Hospital, Chinese Academy of Medical Sciences, Beijing (D.-T.C.), and Shanghai Chest Hospital, Shanghai (B.H.) - all in China; Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai (S.T., B.C.), and Prince of Songkla University, Songkla (P.S.) - both in Thailand; National Taiwan University Hospital, Taipei, Taiwan (C.-H.Y.); National Cancer Center Hospital East, Chiba (N.S., Y.N.), National Kyushu Cancer Center, Fukuoka (Y.I.), National Cancer Center Hospital, Tokyo (Y.O.), AstraZeneca, Osaka (H.J.), and Kinki University School of Medicine, Osaka (M.F.) - all in Japan; Dr. Soetomo Hospital, Surabaya, Indonesia (B.M.); and AstraZeneca, Macclesfield, United Kingdom (E.L.D., C.L.W., A.A.A.). This article (10.1056/NEJMoa0810699) was published on August 19, 2009, at NEJM.org.

BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. METHODS: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. RESULTS: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001).>