Abstract：
BACKGROUND: The data on immune checkpoint inhibitors (ICI) use in lung cancer individuals generally underrepresented in clinical trials are limited. We aimed to examine the ICI access, safety, and outcome in these populations using real-world data.
METHODS: Patients with lung cancer newly started on ICIs from 2018 to 2021 were included. Patient factors (age, sex, race, insurance, Charlson comorbidity index (CCI), Eastern Cooperative Oncology Group (ECOG) performance status, histories of autoimmune disease (AD), infection within 3 months before treatment, and brain metastasis) were collected and grouped. Associations of each patient factor with the time-to-treatment initiation (TTI) of ICIs and immune-related adverse events (irAEs) were examined via cumulative incidence analyses and Chi-squared tests, respectively. Log-rank tests and Cox models were used to assess association of patient factors with overall survival (OS).
RESULTS: Of 125 patients (median age:70 years (50-88), 68 (54.4 %) males), 9 (7.2 %) had Medicaid/uninsured, 44 (35.2 %) had ECOG ≥ 2, 101 (80.8 %) had CCI ≥ 3, 16 (12.8 %) had ADs, 14 (11.2 %) had infections, and 26 (20.8 %) had brain metastases. In newly diagnosed stage IV patients (N = 62), no difference in TTI was found by patient factors. Fifty irAEs occurred within 12 months and no differences in irAEs occurrence by patient factors. In advanced-stage group (N = 123), OS did not differ by patient factors, except for race (p = 0.045). Whites showed an inferior OS than non-Whites in multivariable regression. (Hazards ratio = 2.82 [1.01-7.87], p = 0.047).
CONCLUSIONS: Previously poorly represented subgroups were shown to have no significant delays in ICI use, general tolerance, and comparable outcomes. This adds practical evidence to ICI use in clinically and/or socio-demographically marginalized populations.
METHODS: Patients with lung cancer newly started on ICIs from 2018 to 2021 were included. Patient factors (age, sex, race, insurance, Charlson comorbidity index (CCI), Eastern Cooperative Oncology Group (ECOG) performance status, histories of autoimmune disease (AD), infection within 3 months before treatment, and brain metastasis) were collected and grouped. Associations of each patient factor with the time-to-treatment initiation (TTI) of ICIs and immune-related adverse events (irAEs) were examined via cumulative incidence analyses and Chi-squared tests, respectively. Log-rank tests and Cox models were used to assess association of patient factors with overall survival (OS).
RESULTS: Of 125 patients (median age:70 years (50-88), 68 (54.4 %) males), 9 (7.2 %) had Medicaid/uninsured, 44 (35.2 %) had ECOG ≥ 2, 101 (80.8 %) had CCI ≥ 3, 16 (12.8 %) had ADs, 14 (11.2 %) had infections, and 26 (20.8 %) had brain metastases. In newly diagnosed stage IV patients (N = 62), no difference in TTI was found by patient factors. Fifty irAEs occurred within 12 months and no differences in irAEs occurrence by patient factors. In advanced-stage group (N = 123), OS did not differ by patient factors, except for race (p = 0.045). Whites showed an inferior OS than non-Whites in multivariable regression. (Hazards ratio = 2.82 [1.01-7.87], p = 0.047).
CONCLUSIONS: Previously poorly represented subgroups were shown to have no significant delays in ICI use, general tolerance, and comparable outcomes. This adds practical evidence to ICI use in clinically and/or socio-demographically marginalized populations.
摘要：
背景：在临床试验中通常代表性不足的肺癌个体中使用免疫检查点抑制剂（ICI）的数据有限。我们的目的是检查ICI访问权限，安全,以及使用真实世界数据在这些人群中的结果。
方法：纳入2018年至2021年新开始接受ICIs治疗的肺癌患者。患者因素（年龄，性别,种族,保险,Charlson合并症指数（CCI），东部肿瘤协作组（ECOG）的表现状况，自身免疫性疾病（AD）的历史，治疗前3个月内感染，和脑转移）被收集和分组。通过累积发生率分析和卡方检验，检查了每个患者因素与ICI治疗开始时间（TTI）和免疫相关不良事件（irAE）的关联。分别。使用Log-rank测试和Cox模型来评估患者因素与总生存期（OS）的关联。
结果：125名患者（中位年龄：70岁（50-88岁），68（54.4%）男性，9人（7.2%）有医疗补助/没有保险，44（35.2％）的ECOG≥2，101（80.8％）的CCI≥3，16（12.8％）的AD，14人（11.2%）有感染，26例（20.8%）发生脑转移。在新诊断的IV期患者中（N=62），患者因素没有发现TTI的差异.在12个月内发生了50次irAE，患者因素的irAE发生率没有差异。在晚期组（N=123）中，OS没有因患者因素而异，种族除外（p=0.045）。在多变量回归中，白人的OS比非白人低。(危险比=2.82[1.01-7.87],p=0.047)。
结论：以前代表性较差的亚组显示ICI使用没有明显延迟，一般公差,和可比较的结果。这为ICI在临床和/或社会人口统计学上边缘化的人群中的使用增加了实际证据。
方法：纳入2018年至2021年新开始接受ICIs治疗的肺癌患者。患者因素（年龄，性别,种族,保险,Charlson合并症指数（CCI），东部肿瘤协作组（ECOG）的表现状况，自身免疫性疾病（AD）的历史，治疗前3个月内感染，和脑转移）被收集和分组。通过累积发生率分析和卡方检验，检查了每个患者因素与ICI治疗开始时间（TTI）和免疫相关不良事件（irAE）的关联。分别。使用Log-rank测试和Cox模型来评估患者因素与总生存期（OS）的关联。
结果：125名患者（中位年龄：70岁（50-88岁），68（54.4%）男性，9人（7.2%）有医疗补助/没有保险，44（35.2％）的ECOG≥2，101（80.8％）的CCI≥3，16（12.8％）的AD，14人（11.2%）有感染，26例（20.8%）发生脑转移。在新诊断的IV期患者中（N=62），患者因素没有发现TTI的差异.在12个月内发生了50次irAE，患者因素的irAE发生率没有差异。在晚期组（N=123）中，OS没有因患者因素而异，种族除外（p=0.045）。在多变量回归中，白人的OS比非白人低。(危险比=2.82[1.01-7.87],p=0.047)。
结论：以前代表性较差的亚组显示ICI使用没有明显延迟，一般公差,和可比较的结果。这为ICI在临床和/或社会人口统计学上边缘化的人群中的使用增加了实际证据。
