Inhibitors of the programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) axis are the newest treatment option for metastatic non-small-cell lung cancer (NSCLC). Nivolumab, the first approved PD-1 inhibitor, demonstrated significant survival benefits compared with standard chemotherapy in the second-line setting for both squamous (Checkmate 017) and non-squamous (Checkmate 057) NSCLC. However, subgroup analysis of the Checkmate 057 study revealed that this survival advantage was not observed in patients with epidermal growth factor receptor (EGFR) mutations [1]. This observation was confirmed in the meta-analysis, including three randomized trials comparing PD-1/PD-L1 inhibitors with docetaxel [2]. Currently, it is widely accepted that PD-1/PD-L1 inhibitors are not as effective in patients with EGFR mutations as in patients with wild-type EGFR. On the other hand, anecdotal evidence suggests that some EGFR mutation-positive patients greatly benefit from PD-1/PD-L1 inhibitors. Indeed, in the phase I study of nivolumab, two patients with EGFR mutations survived more than 5 years [3]. Therefore, it is clinically meaningful to identify patient characteristics that affect the efficacy of PD-1/PD-L1 inhibitors in patients with EGFR mutations.

中文翻译：

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Nivolumab在具有EGFR突变的非小细胞肺癌中的应用。

程序性死亡1（PD-1）/程序性死亡配体1（PD-L1）轴的抑制剂是转移性非小细胞肺癌（NSCLC）的最新治疗选择。与鳞癌（Checkmate 017）和非鳞状（Checkmate 057）NSCLC的二线治疗相比，首批批准的PD-1抑制剂Nivolumab与标准化疗相比具有显着的生存获益。然而，对Checkmate 057研究的亚组分析表明，在具有表皮生长因子受体（EGFR）突变的患者中未观察到这种生存优势[1]。该观察结果在荟萃分析中得到了证实，包括三项比较PD-1 / PD-L1抑制剂与多西他赛[2]的随机试验。目前，PD-1 / PD-L1抑制剂在患有以下疾病的患者中不那么有效：EGFR突变与野生型EGFR患者相同。另一方面，轶事证据表明，某些EGFR突变阳性的患者可从PD-1 / PD-L1抑制剂中受益匪浅。确实，在nivolumab的I期研究中，两名EGFR突变患者存活超过5年[3]。因此，鉴定影响EGFR突变患者中PD-1 / PD-L1抑制剂功效的患者特征在临床上具有重要意义。