Objectives

To estimate the average treatment effect of immune checkpoint inhibitors in any line of treatment in a 2016–2018 population-based cohort of patients with advanced non-small-cell lung cancer (NSCLC).

Materials and methods

The cohort, and information on the tumor, were derived from the cancer registry of the Agency for Health Protection of Milan, Italy. Inclusion criteria were adult age, microscopically confirmed NSCLC, stage IIIB or IV at diagnosis, and having received at least one line of treatment. Treatment with all licensed anti PD-1/PD-L1 inhibitors was derived from inpatients and outpatients’ pharmaceutical databases of the ATS and vital status at 31 December 2019 from the health registry office of the Lombardy region. We investigated, with a causal approach, the relationship between survival and anti PD-1/PD-L1 treatment at any line constructing a directed acyclic graph and fitting a Marginal Structural Cox Model (MSCM).

Results

Of 1673 subjects, 324 received anti PD-1/PD-L1 at any treatment line. Overall, one-year survival was 61.1% (95 %CI, 55.6–66.2%) in the group treated with anti PD-1/PD-L1 at any line and 31.1% (95 %CI, 28.6–33.5%) among not treated. One-year hazard ratio (HR) of death for not treated vs. treated was 2.15 (95 %CI, 1.91–2.41), decreasing to 1.23 (95 %CI, 1.03–1.46) at two years and reaching one in the third year.

Conclusion

In un unselected population-based cohort with advanced lung cancer, treatment with anti PD-1/PD-L1 at any line lowered the hazard of death up to two-years from date of diagnosis, confirming the efficacy of immunotherapy outside clinical trials.

中文翻译：

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晚期 NSCLC 任何治疗线上的免疫检查点抑制剂：意大利大型队列的真实总生存率

目标

在 2016-2018 年基于人群的晚期非小细胞肺癌 (NSCLC) 患者队列中，评估免疫检查点抑制剂在任何治疗线中的平均治疗效果。

材料和方法

该队列和有关肿瘤的信息来自意大利米兰卫生保护局的癌症登记处。纳入标准为成年年龄、显微镜下确诊的非小细胞肺癌、诊断时为 IIIB 或 IV 期，并且已接受至少一种治疗。使用所有获得许可的抗 PD-1/PD-L1 抑制剂的治疗均来自伦巴第地区健康登记处截至 2019 年 12 月 31 日的 ATS 和生命状态的住院患者和门诊患者药物数据库。我们使用因果方法研究了在构建有向无环图并拟合边际结构 Cox 模型 (MSCM) 的任何线上的存活率与抗 PD-1/PD-L1 治疗之间的关系。

结果

在 1673 名受试者中，324 名在任何治疗线接受了抗 PD-1/PD-L1。总体而言，在任何线接受抗 PD-1/PD-L1 治疗组的一年生存率为 61.1%（95%CI，55.6-66.2%），未治疗组为 31.1%（95%CI，28.6-33.5%）治疗。未接受治疗与接受治疗的一年死亡风险比 (HR) 为 2.15 (95 % CI, 1.91–2.41)，两年后降至 1.23 (95 %CI, 1.03–1.46) 并在第三年达到 1 .

结论

在未经选择的晚期肺癌人群队列中，任何线的抗 PD-1/PD-L1 治疗均可将死亡风险降低至诊断之日起两年内，证实了临床试验之外免疫疗法的有效性。