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 / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
; : 332-338, 2005.
Article
in English
| WPRIM (Western Pacific)
| ID: wpr-24108
Responsible library:
WPRO
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 ANDMETHODS:
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Arm
/
Adenocarcinoma
/
Prospective Studies
/
Cisplatin
/
Carcinoma, Non-Small-Cell Lung
/
Etoposide
/
Fatigue
/
Febrile Neutropenia
Type of study:
Controlled clinical trial
/
Observational study
/
Prognostic study
/
Risk factors
Limits:
Humans
Language:
English
Journal:
Cancer Research and Treatment
Year:
2005
Document type:
Article