顺铂联合吉西他滨与长春瑞滨或吉西他滨与紫杉醇治疗局部晚期或转移性非小细胞肺癌的疗效：意大利南部肿瘤协作组（SICOG 0101）的一项III期随机试验

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).

作者信息

Comella P, Filippelli G, De Cataldis G, Massidda B, Frasci G, Maiorino L, Putzu C, Mancarella S, Palmeri S, Cioffi R, Roselli M, Buzzi F, Milia V, Gambardella A, Natale D, Bianco M, Ghiani M, Masullo P

机构信息

Department of Medical Oncology, National Tumor Institute, Naples, Italy.

出版信息

Ann Oncol. 2007 Feb;18(2):324-30. doi: 10.1093/annonc/mdl396. Epub 2006 Oct 27.

DOI:10.1093/annonc/mdl396

PMID:17071935

Abstract

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.

摘要

背景

在局部晚期或转移性非小细胞肺癌（NSCLC）中，偶尔有报道称三联方案比双联方案产生更高的缓解率（RR）。本试验旨在评估：（i）在吉西他滨（GEM）和长春瑞滨（VNR）或GEM和紫杉醇（PTX）的基础上加用顺铂（CDDP）是否能显著延长总生存期（OS）；（ii）比较含PTX和含VNR方案的毒性。

患者与方法

III期或IV期NSCLC患者被随机分配至：（i）第1天和第8天接受GEM 1000 mg/m²和VNR 25 mg/m²（GV组）；（ii）第1天和第8天接受GEM 1000 mg/m²和PTX 125 mg/m²（GT组）；（iii）第1天和第8天接受GV加CDDP 50 mg/m²（PGV组）；（iv）第1天和第8天接受GT加CDDP 50 mg/m²（PGT组）。每3周重复治疗，最多6个周期。

结果

共有433例（III期160例，IV期273例）患者被随机分配至本研究。三联方案的RR为48%[95%置信区间（CI），42%至54%]，双联方案为35%（95%CI，32%至38%）（P = 0.004）。中位无进展生存期（6.1个月对5.5个月，P = 0.706）和中位OS（10.7个月对10.5个月，P = 0.379）相似。CDDP显著增加了严重中性粒细胞减少（35%对13%）、血小板减少（14%对4%）、贫血（9%对3%）、呕吐（6%对0.5%）和腹泻（6%对2%）的发生率。相反，含VNR方案的严重中性粒细胞减少（30%对17%）和血小板减少（11%对6%）发生率显著更高。