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.
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.
Lee
Nam-Su
NS
Department of Internal Medicine, College of Medicine, Soon Chun Hyang University, Seoul, Korea.
Park
Hee-Sook
HS
Won
Jong-Ho
JH
Hong
Dae-Sik
DS
Uh
Su-Taek
ST
Lee
Sang-Jae
SJ
Kim
Joo-Hang
JH
Kim
Se-Kyu
SK
Ahn
Myung-Ju
MJ
Choi
Jung-Hye
JH
Yang
Suk-Chul
SC
Lee
Jung-Ae
JA
Lee
Keun-Seok
KS
Yim
Chang-Yeol
CY
Lee
Yong-Chul
YC
Kim
Chul-Soo
CS
Lee
Moon-Hee
MH
Jung
Kab-Do
KD
Moon
Hanlim
H
Lee
Yl-Sub
YS