Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, Connecticut.
JAMA Oncol. 2023 Mar 1;9(3):334-341. doi: 10.1001/jamaoncol.2022.6901.
IMPORTANCE: The introduction of immune checkpoint inhibitors (ICIs) has transformed the care of advanced non-small cell lung cancer (NSCLC). Although clinical trials suggest substantial survival benefits, it is unclear how outcomes have changed in clinical practice. OBJECTIVE: To assess temporal trends in ICI use and survival among patients with advanced NSCLC across age strata. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was performed in approximately 280 predominantly community-based US cancer clinics and included patients aged 18 years or older who had stage IIIB, IIIC, or IV NSCLC diagnosed between January 1, 2011, and December 31, 2019, with follow-up through December 31, 2020. Data were analyzed April 1, 2021, to October 19, 2022. MAIN OUTCOMES AND MEASURES: Median overall survival and 2-year survival probability. The predicted probability of 2-year survival was calculated using a mixed-effects logit model adjusting for demographic and clinical characteristics. RESULTS: The study sample included 53 719 patients (mean [SD] age, 68.5 [9.3] years; 28 374 men [52.8%]), the majority of whom were White individuals (36 316 [67.6%]). The overall receipt of cancer-directed therapy increased from 69.0% in 2011 to 77.2% in 2019. After the first US Food and Drug Administration approval of an ICI for NSCLC, the use of ICIs increased from 4.7% in 2015 to 45.6% in 2019 (P < .001). Use of ICIs in 2019 was similar between the youngest and oldest patients (aged <55 years, 45.2% vs aged ≥75 years, 43.8%; P = .59). From 2011 to 2018, the predicted probability of 2-year survival increased from 37.7% to 50.3% among patients younger than 55 years and from 30.6% to 36.2% in patients 75 years or older (P < .001). Similarly, median survival in patients younger than 55 years increased from 11.5 months to 16.0 months during the study period, while survival among patients 75 years or older increased from 9.1 months in 2011 to 10.2 months in 2019. CONCLUSIONS AND RELEVANCE: This cohort study found that, among patients with advanced NSCLC, the uptake of ICIs after US Food and Drug Administration approval was rapid across all age groups. However, corresponding survival gains were modest, particularly in the oldest patients.
重要性：免疫检查点抑制剂（ICI）的引入改变了晚期非小细胞肺癌（NSCLC）的治疗方式。虽然临床试验表明其具有显著的生存获益，但在临床实践中其疗效的变化尚不清楚。
目的：评估不同年龄组晚期 NSCLC 患者中 ICI 使用和生存的时间趋势。
设计、地点和参与者：本队列研究在大约 280 家主要为社区的美国癌症诊所进行，纳入了 2011 年 1 月 1 日至 2019 年 12 月 31 日期间诊断为 IIIB、IIIC 或 IV 期 NSCLC 的年龄在 18 岁及以上的患者，并随访至 2020 年 12 月 31 日。数据分析于 2021 年 4 月 1 日至 2022 年 10 月 19 日进行。
主要结局和测量指标：中位总生存期和 2 年生存率。采用混合效应 logit 模型预测 2 年生存率，该模型调整了人口统计学和临床特征。
结果：研究样本包括 53719 名患者（平均[SD]年龄 68.5[9.3]岁；28374 名男性[52.8%]），其中大多数为白人（36316 名[67.6%]）。接受癌症靶向治疗的比例从 2011 年的 69.0%增加到 2019 年的 77.2%。在美国食品药品监督管理局（FDA）首次批准 NSCLC 的 ICI 后，ICI 的使用从 2015 年的 4.7%增加到 2019 年的 45.6%（P<0.001）。2019 年，最年轻和最年长患者使用 ICI 的比例相似（年龄<55 岁患者为 45.2%，年龄≥75 岁患者为 43.8%；P=0.59）。从 2011 年到 2018 年，年龄<55 岁的患者 2 年生存率预测值从 37.7%增加到 50.3%，年龄≥75 岁的患者从 30.6%增加到 36.2%（P<0.001）。同样，年龄<55 岁的患者中位生存期从研究期间的 11.5 个月增加到 16.0 个月，而年龄≥75 岁的患者中位生存期从 2011 年的 9.1 个月增加到 2019 年的 10.2 个月。
结论和相关性：本队列研究发现，在美国 FDA 批准后，晚期 NSCLC 患者中 ICI 的使用率在所有年龄组均迅速上升。然而，相应的生存获益是适度的，尤其是在最年长的患者中。
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