顺铂联合吉西他滨对比含顺铂三联方案与非铂类序贯双药方案治疗晚期非小细胞肺癌：西班牙肺癌研究组III期随机试验

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.

作者信息

Alberola V, Camps C, Provencio M, Isla D, Rosell R, Vadell C, Bover I, Ruiz-Casado A, Azagra P, Jiménez U, González-Larriba J L, Diz P, Cardenal F, Artal A, Carrato A, Morales S, Sanchez J J, de las Peñas R, Felip E, López-Vivanco G

机构信息

Hospital Arnau de Vilanova, San Clemente 12, 46015 Valencia, Spain.

出版信息

J Clin Oncol. 2003 Sep 1;21(17):3207-13. doi: 10.1200/JCO.2003.12.038.

DOI:10.1200/JCO.2003.12.038

PMID:12947054

Abstract

PURPOSE

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).

PATIENTS AND METHODS

Stage IIIB to IV NSCLC patients were randomly assigned to receive cisplatin 100 mg/m2 day 1 plus gemcitabine 1,250 mg/m2 days 1 and 8, every 3 weeks for six cycles (CG); cisplatin 100 mg/m2 day 1 plus gemcitabine 1,000 mg/m2 and vinorelbine 25 mg/m2 days 1 and 8, every 3 weeks for six cycles (CGV); or gemcitabine 1,000 mg/m2 plus vinorelbine 30 mg/m2 days 1 and 8, every 3 weeks for three cycles, followed by vinorelbine 30 mg/m2 days 1 and 8 plus ifosfamide 3 g/m2 day 1, every 3 weeks for three cycles (GV-VI).

RESULTS

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).

CONCLUSION

On the basis of these results, CG remains a standard regimen for first-line treatment of advanced NSCLC.

摘要

目的

比较顺铂联合吉西他滨、含顺铂的三联方案以及非铂类序贯双联方案在晚期非小细胞肺癌（NSCLC）中所获得的生存获益。

患者与方法

ⅢB期至Ⅳ期NSCLC患者被随机分配接受以下治疗：顺铂100mg/m²第1天联合吉西他滨1250mg/m²第1天和第8天，每3周1次，共6个周期（CG）；顺铂100mg/m²第1天联合吉西他滨1000mg/m²及长春瑞滨25mg/m²第1天和第8天，每3周1次，共6个周期（CGV）；或吉西他滨1000mg/m²联合长春瑞滨30mg/m²第1天和第8天，每3周1次，共3个周期，随后长春瑞滨30mg/m²第1天和第8天联合异环磷酰胺3g/m²第1天，每3周1次，共3个周期（GV-VI）。

结果

557例患者被分配接受治疗（182例CG，188例CGV，187例GV-VI）。非铂类序贯双联方案的缓解率显著更低（CG为42%；CGV为41%；GV-VI为27%；CG与GV-VI比较，P = 0.003）。未观察到中位生存期或疾病进展时间存在差异。三联方案的毒性更高：3至4级中性粒细胞减少（CG为32%；CGV为57%；GV-VI为27%；P < 0.05）；中性粒细胞减少性发热（CG为4%；CGV为19%；GV-VI为5%；P < 0.0001）；3至4级血小板减少（CG为19%；CGV为23%；GV-VI为3%；P = 0.0001）；以及3至4级呕吐（CG为22%；CGV为32%；GV-VI为6%；P < 0.0001）。