Background Long-term data with immune checkpoint inhibitors in non-small-cell lung cancer (NSCLC) are limited. Two phase III trials demonstrated improved overall survival (OS) and a favorable safety profile with the anti-programmed death-1 antibody nivolumab versus docetaxel in patients with previously treated advanced squamous (CheckMate 017) and nonsquamous (CheckMate 057) NSCLC. We report results from ≥3 years' follow-up, including subgroup analyses of patients with liver metastases, who historically have poorer prognosis among patients with NSCLC. Patients and methods Patients were randomized 1 : 1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks) until progression or discontinuation. The primary end point of each study was OS. Patients with baseline liver metastases were pooled across studies by treatment for subgroup analyses. Results After 40.3 months' minimum follow-up in CheckMate 017 and 057, nivolumab continued to show an OS benefit versus docetaxel: estimated 3-year OS rates were 17% [95% confidence interval (CI), 14% to 21%] versus 8% (95% CI, 6% to 11%) in the pooled population with squamous or nonsquamous NSCLC. Nivolumab was generally well tolerated, with no new safety concerns identified. Of 854 randomized patients across both studies, 193 had baseline liver metastases. Nivolumab resulted in improved OS compared with docetaxel in patients with liver metastases (hazard ratio, 0.68; 95% CI, 0.50-0.91), consistent with findings from the overall pooled study population (hazard ratio, 0.70; 95% CI, 0.61-0.81). Rates of treatment-related hepatic adverse events (primarily grade 1-2 liver enzyme elevations) were slightly higher in nivolumab-treated patients with liver metastases (10%) than in the overall pooled population (6%). Conclusions After 3 years' minimum follow-up, nivolumab continued to demonstrate an OS benefit versus docetaxel in patients with advanced NSCLC. Similarly, nivolumab demonstrated an OS benefit versus docetaxel in patients with liver metastases, and remained well tolerated. Clinical trial registration CheckMate 017: NCT01642004; CheckMate 057: NCT01673867.

中文翻译：

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在先前治疗的晚期非小细胞肺癌（CheckMate 017和CheckMate 057）中，Nivolumab与docetaxel的比较：肝转移患者的3年更新和预后。

背景非小细胞肺癌（NSCLC）中使用免疫检查点抑制剂的长期数据有限。两项III期临床试验表明，在先前接受过治疗的晚期鳞状（CheckMate 017）和非鳞状（CheckMate 057）NSCLC患者中，抗编程死亡1抗体尼伏鲁单抗与多西他赛相比，总生存率（OS）有所改善，并且安全性良好。我们报告了≥3年的随访结果，包括对肝转移患者的亚组分析，这些患者历来在NSCLC患者中预后较差。患者和方法患者按1：1的比例随机分配至nivolumab（每2周3 mg / kg）或多西他赛（每3周75 mg / m2），直至进展或停药。每个研究的主要终点是OS。基线肝转移的患者通过治疗进行分组研究，以进行亚组分析。结果在对CheckMate 017和057进行了至少40.3个月的随访之后，与多西紫杉醇相比，nivolumab仍然显示出OS获益：估计的3年OS率为17％[95％置信区间（CI），14％至21％]鳞状或非鳞状非小细胞肺癌合并人群中有8％（95％CI，6％至11％）。Nivolumab的耐受性一般良好，未发现新的安全隐患。在两项研究中的854位随机患者中，有193位发生了基线肝转移。与多西紫杉醇相比，Nivolumab可使肝转移患者的OS改善（危险比，0.68； 95％CI，0.50-0.91），与总研究人群的发现一致（危险比，0.70； 95％CI，0.61-0.81） ）。接受尼古鲁单抗治疗的肝转移患者（10％）的治疗相关肝不良事件（主要是1-2级肝酶升高）的发生率略高于总人群（6％）。结论最少随访3年后，对于晚期NSCLC患者，nivolumab继续表现出优于多西他赛的OS获益。同样，对于肝转移患者，nivolumab与多西紫杉醇相比具有OS获益，并且耐受性良好。临床试验注册CheckMate 017：NCT01642004；CheckMate 057：NCT01673867。在晚期NSCLC患者中，nivolumab继续显示出与多西他赛相比OS获益。同样，对于肝转移患者，nivolumab与多西紫杉醇相比具有OS获益，并且耐受性良好。临床试验注册CheckMate 017：NCT01642004；CheckMate 057：NCT01673867。在晚期NSCLC患者中，nivolumab继续显示出与多西他赛相比OS获益。同样，对于肝转移患者，nivolumab与多西紫杉醇相比具有OS获益，并且耐受性良好。临床试验注册CheckMate 017：NCT01642004；CheckMate 057：NCT01673867。