Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: Results from a randomized phase III trial with 5 years' follow-up

被引:354
作者
Sundstrom, S
Bremnes, RM [1 ]
Kaasa, S
Aasebo, U
Hatlevoll, R
Dahle, R
Boye, N
Wang, M
Vigander, T
Vilsvik, J
Skovlund, E
Hannisdal, E
Aamdal, S
机构
[1] Univ Tromso Hosp, Dept Oncol, N-9038 Tromso, Norway
[2] Univ Tromso Hosp, Dept Pulmonol, N-9038 Tromso, Norway
[3] Univ Trondheim Hosp, Dept Oncol, N-7006 Trondheim, Norway
[4] Univ Trondheim Hosp, Dept Pulmonol, N-7006 Trondheim, Norway
[5] Ulleval Hosp, Dept Oncol, Oslo, Norway
[6] Ulleval Hosp, Dept Pulmonol, Oslo, Norway
[7] Norwegian Radium Hosp, Dept Oncol, Oslo, Norway
[8] Ostfold Sent Sykehus, Dept Internal Med, Fredrikstad, Norway
[9] Haukeland Hosp, Dept Pulmonol, N-5021 Bergen, Norway
关键词
D O I
10.1200/JCO.2002.12.111
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To investigate whether chemotherapy with etoposide and cisplatin (EP) is superior to cyclophosphamide, epirubicin, and vincristine (CEV) in small-cell lung cancer (SCLC). Patients and Methods: A total of 436 eligible patients were randomized to chemotherapy with EP (n=218) or CEV (n=218). Patients were stratified according to extent of disease (limited disease [LD], n=214; extensive disease [ED], n=222). The EP group received five courses of etoposide 100 mg/m(2) intravenously (IV) and cisplatin 75 mg/m(2) IV on day 1, followed by oral etoposide 200 mg/m(2) daily on days 2 to 4. The CEV group received five courses of epirubicin 50 mg/m(2), cyclophosphamide 1,000 mg/m(2), and vincristine 2 mg, all IV on day 1. In addition, LD patients received thoracic radiotherapy concurrent with chemotherapy cycle 3, and those achieving complete remission during the treatment period received prophylactic cranial irradiation. Results: The treatment groups were well balanced with regard to age, sex, and prognostic factors such as weight loss, and performance status. The 2- and 5-year survival rates in the EP arm (14% and 5%, P=.0004) were significantly higher compared with those in the CEV arm (6% and 2%a). Among LD patients, median survival time was 14.5 months versus 9.7 months in the EP and CEV arms, respectively (P=.001). The 2- and 5-year survival rates of 25% and 10% in the EP arm compared with 8% and 3% in the CEV arm (P=.0001). For ED patients, there was no significant survival difference between the treatment arms. Quality-of-life assessments revealed no major differences between the randomized groups. Conclusion: EP is superior to CEV in LD-SCLC patients. In ED-SCLC patients, the benefits of EP and CEV chemotherapy seem equivalent, with similar survival time and quality of life.
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页码:4665 / 4672
页数:8
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