Division of Hematology-Oncology, Department of Medicine, Tufts Medical Center, Boston, MA, United States; Department of Medicine, Tufts Medical Center, Boston, MA, United States.
Department of Medicine, Tufts Medical Center, Boston, MA, United States.
Cancer Treat Res Commun. 2024;40:100833. doi: 10.1016/j.ctarc.2024.100833. Epub 2024 Jul 9.
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.
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).
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).
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.
在临床试验中代表性不足的肺癌患者使用免疫检查点抑制剂（ICI）的数据有限。我们旨在使用真实世界的数据来研究这些人群的 ICI 获得途径、安全性和结局。
纳入 2018 年至 2021 年新开始接受 ICI 治疗的肺癌患者。收集患者因素（年龄、性别、种族、保险、Charlson 合并症指数（CCI）、东部合作肿瘤学组（ECOG）表现状态、自身免疫性疾病（AD）史、治疗前 3 个月内感染和脑转移）并进行分组。通过累积发生率分析和卡方检验分别评估每个患者因素与 ICI 治疗起始时间（TTI）和免疫相关不良事件（irAE）的关联。对数秩检验和 Cox 模型用于评估患者因素与总生存期（OS）的关联。
在 125 名患者中（中位年龄：70 岁（50-88），68 名男性（54.4%）），9 名（7.2%）为医疗补助/无保险，44 名（35.2%）ECOG≥2，101 名（80.8%）CCI≥3，16 名（12.8%）有 AD，14 名（11.2%）有感染，26 名（20.8%）有脑转移。在新诊断的 IV 期患者（N=62）中，患者因素对 TTI 无差异。在 12 个月内发生了 50 例 irAE，且患者因素对 irAE 发生无差异。在晚期患者组（N=123）中，除种族外（p=0.045），患者因素与 OS 无差异。在多变量回归中，白人的 OS 明显劣于非白人。（风险比=2.82[1.01-7.87]，p=0.047）。
先前代表性不足的亚组在 ICI 使用、总体耐受性和可比结局方面没有明显延迟。这为在临床和/或社会人口统计学上处于边缘地位的人群中使用 ICI 提供了实际证据。
