来源：SCI
- Passiglia Francesco,Cappuzzo Federico,Alabiso Oscar et al. Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations.[J] .Br. J. Cancer, 2018, undefined: undefined.
- Correspondence: Federico Cappuzzo (federico.cappuzzo@auslromagna.it)
BACKGROUND 背景
The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouringKRASmutations.
本研究调查了nivolumab在具有KRAS突变晚期NSCLC预治疗患者中的疗效和安全性。
METHODS 方法
Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events.
在IEAP计划中使用nivolumab治疗的患者中分析临床数据和KRAS突变状态。评估客观反应率，无进展生存期和总生存期。使用美国国家癌症研究所不良事件常用术语标准监测患者的不良事件。
RESULTS 结果
Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) wereKRASwild-type mutations.KRASstatus did not influence nivolumab efficacy in terms of ORR (20% vs 17%,P=0.39) and DCR (47% vs 41%,P=0.23).
在评估KRAS突变的530名患者中，206名（39％）为阳性，而324名（61％）为KRASwild型突变.KRASstatus在ORR（20％vs 17％，P = 0.39）和DCR方面不影响nivolumab疗效（ 47％对41％，P = 0.23）。
The median PFS and OS were 4 vs 3 months (P=0.5) and 11.2 vs 10 months (P=0.8) in theKRAS-positive vs the KRAS-negative group. The 3-months PFS rate was significantly higher in theKRAS-positive group as compared to theKRAS-negative group (53% vs 42%,P=0.01). The percentage of any grade and grade 3–4 AEs were 45% vs 33% (P=0.003) and 11% vs 6% (P=0.03) inKRASpositive andKRAS-negative groups, respectively.
KAS阳性与KRAS阴性组相比，中位PFS和OS分别为4 vs 3个月（P = 0.5）和11.2 vs 10个月（P = 0.8）。与KRAS阴性组相比，KRAS阳性组的3个月PFS率显着更高（53％vs 42％，P = 0.01）。在KRASP阳性和KRAS阴性组中，任何等级和3-4级AE的百分比分别为45％和33％（P = 0.003）和11％对6％（P = 0.03）。
CONCLUSIONS 结论
Nivolumab is an effective and safe treatment option for patients with previously treated, advanced non-squamous NSCLC regardless of KRAS mutations
对于既往治疗的晚期非鳞癌患者，无论是否有kras突变，Nivolumab是一种有效且安全的治疗选择