1.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.
Nam Su LEE ; 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
Cancer Research and Treatment 2005;37(6):332-338
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.
Adenocarcinoma
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Arm
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Carcinoma, Non-Small-Cell Lung*
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Cisplatin*
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Etoposide*
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Fatigue
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Febrile Neutropenia
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Humans
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Prospective Studies
Result Analysis
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