Cisplatin plus gemcitabine versus a cisplatin-based triplet versus nonplatinum sequential doublets in advanced non-small-cell lung cancer:: A Spanish lung cancer group phase III randomized trial

被引:138
作者
Alberola, V
Camps, C
Provencio, M
Isla, D
Rosell, R
Vadell, C
Bover, I
Ruiz-Casado, A
Azagra, P
Jiménez, U
González-Larriba, JL
Diz, P
Cardenal, F
Artal, A
Carrato, A
Morales, S
Sánchez, JJ
de las Peñas, R
Felip, E
López-Vivanco, G
机构
[1] Hosp Arnau Vilanova, Div Med Oncol, Valencia 46015, Spain
[2] Univ Valencia, Gen Hosp, Div Med Oncol, Valencia, Spain
[3] Puerta Hierro Hosp, Div Med Oncol, Madrid, Spain
[4] La Princesa Hosp, Div Med Oncol, Madrid, Spain
[5] San Carlos Univ Hosp, Div Med Oncol, Madrid, Spain
[6] Autonomous Univ Madrid, Dept Prevent Med, E-28049 Madrid, Spain
[7] Univ Hosp, Div Med Oncol, Zaragoza, Spain
[8] Hosp Badalona Germans Trias & Pujol, Div Med Oncol, Badalona, Spain
[9] Hosp Mar, Div Med Oncol, Barcelona, Spain
[10] Duran Reynals Hosp, Div Med Oncol, Barcelona, Spain
[11] Hosp Gen Valle Hebron, Div Med Oncol, Barcelona, Spain
[12] San Juan Hosp, Div Med Oncol, Reus, Spain
[13] Arquitecto Marcide Hosp, Div Med Oncol, El Ferrol, Spain
[14] Leon Hosp, Div Med Oncol, Leon, Spain
[15] Miguel Servet Hosp, Div Med Oncol, Zaragoza, Spain
[16] Univ Alicante, Elche Hosp, Div Med Oncol, E-03080 Alicante, Spain
[17] Arnau Vilanova Hosp, Div Med Oncol, Lerida, Spain
[18] Provincial Hosp, Div Med Oncol, Castellon de La Plana, Spain
[19] Cruces Hosp, Div Med Oncol, Bilbao, Spain
关键词
D O I
10.1200/JCO.2003.12.038
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
(P) under bar(u) under bar(r) under bar(p) under bar(o) under bar(s) under bar(e) under bar: To compare the survival benefit obtained with cisplatin plus gemcitabine, a cisplatin-based triplet, and nonplatinum sequential doublets in advanced non-small-cell lung cancer (NSCLC). (P) under bar(a) under bar(t) under bar(i) under bar(e) under bar(n) under bar(t) under bar(s) under bar (a) under bar(n) under bar(d) under bar (M) under bar(e) under bar(t) under bar(h) under bar(o) under bar(d) under bar(s) under bar: Stage IIIB to IV NSCLC patients were randomly assigned to receive cisplatin 100 mg/m(2) day 1 plus gemcitabine 1,250 mg/m(2) days 1 and 8, every 3 weeks for six cycles (CG); cisplatin 100 mg/m(2) day 1 plus gemcitabine 1,000 mg/m(2) and vinorelbine 25 mg/m(2) days 1 and 8, every 3 weeks for six cycles (CGV); or gemcitabine 1,000 mg/m(2) plus vinorelbine 30 mg/m(2) days 1 and 8, every 3 weeks for three cycles, followed by vinorelbine 30 mg/m(2) days 1 and 8 plus ifosfamide 3 g/m(2) day 1, every 3 weeks for three cycles (GV-VI). (R) under bar(e) under bar(s) under bar(u) under bar(l) under bar(t) under bar(s) under bar: Five hundred fifty-seven patients were assigned to treatment (182 CG, 188 CGV, 187 GV-VI). Response rates were significantly inferior for the nonplatinum sequential doublet (CG, 42%; CGV, 41%; GV-VI, 27%; CG v GV-VI, P = .003). No differences in median survival or time to progression were observed. Toxicity was higher for the triplet: grade 3 to 4 neutropenia (GC, 32%; CGV, 57%; GV-VI, 27%; P < .05); neutropenic fever (CG, 4%; CGV, 19%; GV-VI, 5%; P < .0001); grade 3 to 4 thrombocytopenia (CG, 19%; CGV, 23%; GV-VI, 3%; P = .0001); and grade 3 to 4 emesis (GC, 22%; GCV, 32%; GV-VI, 6%; P < .0001). (C) under bar(o) under bar(n) under bar(c) under bar(l) under bar(u) under bar(s) under bar(i) under bar(o) under bar(n) under bar: On the basis of these results, CG remains a standard regimen for first-line treatment of advanced NSCLC. (C) 2003 by American Society of Clinical Oncology.
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页码:3207 / 3213
页数:7
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