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.
- Author:
Nam Su LEE
1
;
Hee Sook PARK
;
Jong Ho WON
;
Dae Sik HONG
;
Su Taek UH
;
Sang Jae LEE
;
Joo Hang KIM
;
Se Kyu KIM
;
Myung Ju AHN
;
Jung Hye CHOI
;
Suk Chul YANG
;
Jung Ae LEE
;
Keun Seok LEE
;
Chang Yeol YIM
;
Yong Chul LEE
;
Chul Soo KIM
;
Moon Hee LEE
;
Kab Do JUNG
;
Hanlim MOON
;
Yl Sub LEE
Author Information
1. Department of Internal Medicine, College of Medicine, Soon Chun Hyang University, Seoul, Korea. parkhs@hosp.sch.ac.kr
- Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Docetaxel;
Etoposide;
Cisplatin;
Non-small- cell lung carcinoma
- MeSH:
Adenocarcinoma;
Arm;
Carcinoma, Non-Small-Cell Lung*;
Cisplatin*;
Etoposide*;
Fatigue;
Febrile Neutropenia;
Humans;
Prospective Studies
- From:Cancer Research and Treatment
2005;37(6):332-338
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: 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). MATERIALS AND METHODS: Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m2 on day 1 and either docetaxel 75 mg/m2 on day 1 or etoposide 100 mg/m2 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. CONCLUSION: 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.
