Efficacy of the combination of cisplatin with either gemcitabine and vinorelbine or gemcitabine and paclitaxel in the treatment of locally advanced or metastatic non-small-cell lung cancer: a phase III randomised trial of the Southern Italy Cooperative Oncology Group (SICOG 0101)
Efficacy of the combination of cisplatin with either gemcitabine and vinorelbine or gemcitabine and paclitaxel in the treatment of locally advanced or metastatic non-small-cell lung cancer: a phase III randomised trial of the Southern Italy Cooperative Oncology Group (SICOG 0101)
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DOI：
10.1093/annonc/mdl396
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发表时间：
2007-02-01
影响因子：
50.5
通讯作者：
Masullo, P.
中科院分区：
文献类型：
--
作者：
Comella, P.;Filippelli, G.;Masullo, P.
背景资料：在局部晚期或转移性非小细胞肺癌（NSCLC）中，三联方案的缓解率（RR）偶尔高于双联方案。进行该试验以评估（i）将顺铂（CDDP）添加至吉西他滨（GEM）和长春瑞滨（VNR）或GEM和紫杉醇（PTX）是否显著延长总生存期（OS）和（ii）比较含PTX和含VNR组合的毒性。III期或IV期NSCLC患者被随机分配至（i）GEM 1000 mg/m2（第1天和第8天）和VNR 25 mg/m2（GV组）;（ii）GEM 1000 mg/m2和PTX 125 mg/m2，第1天和第8天（GT组）;（iii）GV加CDDP 50 mg/m2，第1天和第8天（PGV组）;和（iv）GT加CDDP 50 mg/m2，第1天和第8天（PGT组）。治疗每3周重复一次，最多6个cycles.Results：共433（III期，160; IV期，273）患者被随机分配到研究。三胞胎的RR为48% [95%置信区间（CI），42%至54%]，双胞胎为35%（95% CI，32%至38%）（P = 0.004）。中位无进展生存期（6.1 vs 5.5个月，P = 0.706）和中位OS（10.7 vs 10.5个月，P = 0.379）相似。CDDP显著增加了重度中性粒细胞减少（35% vs 13%）、血小板减少（14% vs 4%）、贫血（9% vs 3%）、呕吐（6% vs 0.5%）和腹泻（6% vs 2%）的发生率。相反，严重的中性粒细胞减少症（30%比17%）和血小板减少症（11%比6%）的频率显着较高的VNR含regiments.Conclusions：CDDP添加到GV或GT显着增加RR，但没有延长患者的OS。在双联治疗中，鉴于GT方案的安全性更好，应首选GT方案。
Background: Triplet regimens were occasionally reported to produce a higher response rate (RR) than doublets in locally advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was conducted to assess (i) whether the addition of cisplatin (CDDP) to either gemcitabine (GEM) and vinorelbine (VNR) or GEM and paclitaxel (PTX) significantly prolongs overall survival (OS) and (ii) to compare the toxicity of PTX-containing and VNR-containing combinations.Patients and methods: Stage III or IV NSCLC patients were randomly assigned to (i) GEM 1000 mg/m(2) and VNR 25 mg/m(2) on days 1 and 8 (GV arm); (ii) GEM 1000 mg/m(2) and PTX 125 mg/m(2) on days 1 and 8 (GT arm); (iii) GV plus CDDP 50 mg/m(2) on days 1 and 8 (PGV arm); and (iv) GT plus CDDP 50 mg/m(2) on days 1 and 8 (PGT arm). Treatments were repeated every 3 weeks for a maximum of six cycles.Results: A total of 433 (stage III, 160; stage IV, 273) patients were randomly allocated to the study. RR was 48% [95% confidence interval (CI), 42% to 54%] for triplets and 35% (95% CI, 32% to 38%) for doublets (P = 0.004). Median progression-free survival (6.1 versus 5.5 months, P = 0.706) and median OS (10.7 versus 10.5 months, P = 0.379) were similar. CDDP significantly increased the occurrence of severe neutropenia (35% versus 13%), thrombocytopenia (14% versus 4%), anaemia (9% versus 3%), vomiting (6% versus 0.5%), and diarrhoea (6% versus 2%). Conversely, frequency of severe neutropenia (30% versus 17%) and thrombocytopenia (11% versus 6%) was significantly higher with VNR-containing regimens.Conclusions: Adding CDDP to GV or GT significantly increased RR, but did not prolong the OS of patients. Among doublets, the GT regimen should be preferred in view of its better safety profile.