title: Randomized, multi-center phase II trial of docetaxel plus cisplatin versus etoposide plus cisplatin as the first-line therapy for patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  We prospectively conducted a multi-center, open-label, randomized phase II trial to compare the efficacy and safety of docetaxel plus cisplatin (DC) and etoposide plus cisplatin (EC) for treating advanced stage non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m(2) on day 1 and either docetaxel 75 mg/m(2) on day 1 or etoposide 100 mg/m(2) on days 1 to 3 in the DC or EC arm, respectively, every 3 weeks.
  
  
  RESULTS
  The objective response rate was 39.4% (15/38) and 18.4% (7/38) (p=0.023) in the DC and EC arms, respectively. The median time to progression (TTP) was 5.9 and 2.7 months (p=0.119), and the overall survival was 12.1 and 8.7 months (p=0.168) in the DC and EC arms, respectively. The prognostic factors for longer survival were an earlier disease stage (stage III, p=0.0095), the responders to DC (p=0.0174) and the adenocarcinoma histology (p=0.0454). The grades 3 and 4 toxicities were similar in both arms, with more febrile neutropenia (7.9% vs. 0%) and fatigue (7.9% vs. 0%) being noted in the DC arm.
  
  
  CONCLUSIONS
  DC offered a superior overall response rate than does EC, along with tolerable toxicity profiles, although the DC drug combination did not show significantly improved survival and TTP.
authors: Department of Internal Medicine, College of Medicine, Soon Chun Hyang University, Seoul, Korea.
authors: Nam-Su
authors: NS
authors: Lee
authors: Hee-Sook
authors: HS
authors: Park
authors: Jong-Ho
authors: JH
authors: Won
authors: Dae-Sik
authors: DS
authors: Hong
authors: Su-Taek
authors: ST
authors: Uh
authors: Sang-Jae
authors: SJ
authors: Lee
authors: Joo-Hang
authors: JH
authors: Kim
authors: Se-Kyu
authors: SK
authors: Kim
authors: Myung-Ju
authors: MJ
authors: Ahn
authors: Jung-Hye
authors: JH
authors: Choi
authors: Suk-Chul
authors: SC
authors: Yang
authors: Jung-Ae
authors: JA
authors: Lee
authors: Keun-Seok
authors: KS
authors: Lee
authors: Chang-Yeol
authors: CY
authors: Yim
authors: Yong-Chul
authors: YC
authors: Lee
authors: Chul-Soo
authors: CS
authors: Kim
authors: Moon-Hee
authors: MH
authors: Lee
authors: Kab-Do
authors: KD
authors: Jung
authors: Hanlim
authors: H
authors: Moon
authors: Yl-Sub
authors: YS
authors: Lee