Cancer Res Treat.  2005 Dec;37(6):332-338.

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

• Lee NS
• Park HS
• Won JH
• Hong DS
• Uh ST
• Lee SJ
• Kim JH
• Kim SK
• Ahn MJ
• Choi JH
• Yang SC
• Lee JA
• Lee KS
• Yim CY
• Lee YC
• Kim CS
• Lee MH
• Jung KD
• Moon H
• Lee YS

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.

Keyword

Docetaxel; Etoposide; Cisplatin; Non-small- cell lung carcinoma

MeSH Terms

Adenocarcinoma
Arm
Carcinoma, Non-Small-Cell Lung*
Cisplatin*
Etoposide*
Fatigue
Febrile Neutropenia
Humans
Prospective Studies
Cisplatin
Etoposide

Figure

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  Fig. 1 Overall survival of the DC-treated and EC-treated patients.

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  Fig. 2 Survival curves of the responders and non-responders in each treatment arm. (A) Docetaxel group. (B) Etoposide group. (C) Both groups.

• 

  Fig. 3 Time to progression for the DC-treated and EC-treated patients.

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