2016 年至 2021 年澳大利亚北领地顶端实体瘤患者免疫检查点抑制剂的真实经验:一项回顾性观察队列研究。
Real-world experience of immune checkpoint inhibitors in patients with solid tumours in the Top End of the Northern Territory, Australia from 2016 to 2021: a retrospective observational cohort study.
发表日期:2024 Jul 05
作者:
Abigail R Miller, Aries Balino, Sandy Tun Min, Teesha Downton, Narayan V Karanth, Alison Backen, Michail Charakidis
来源:
Immunity & Ageing
摘要:
免疫检查点抑制剂的使用正在增长,但临床试验数据可能不适用于原住民患者或居住在偏远地区的患者。提供北领地顶端免疫相关不良事件 (irAE) 的真实发生率并进行比较这项回顾性、观察性、队列研究收集了 2016 年 1 月至 2021 年 12 月期间居住在北端地区接受免疫治疗的实体器官癌患者的电子记录数据。主要结果是任何级别和严重癌症的累积发生率红外辐射发射机。次要结局是总生存期、治疗持续时间和治疗停止的原因。226 名患者接受了免疫治疗。四十八人 (21%) 居住在偏远或非常偏远地区,其中 36 人 (16%) 是原住民。任何级别 irAE 的累积发生率为 54%(122/226 名患者);严重 irAE 的发生率为 26%(59/226 名患者)。任何级别(42% vs 56%,P = 0.11)和严重(11% vs 18%,P = 0.29)irAE 的土著和非土著患者之间的发生率相似。然而,土著患者的治疗持续时间较短,由于患者偏好而更频繁地停止治疗,并且中位总生存期似乎比非土著患者更短(17.1 个月与 30.4 个月;风险比 (HR) = 1.5,95% 置信区间 (CI) ) = 0.92-2.66)。偏远地区和城市患者之间的死亡率没有差异(中位总生存期为 27.5 个月与 30.2 个月;HR = 1.1,95% CI = 0.7-1.7)。我们队列中的 irAE 发生率与已发表的文献中的相当。土著和非土著患者之间观察到的任何级别或严重 irAE 发生率没有显着差异。© 2024 作者。约翰·威利 (John Wiley) 出版的内科杂志
Use of immune checkpoint inhibitors is growing, but clinical trial data may not apply to Indigenous patients or patients living in remote areas.To provide real-world incidence of immune-related adverse events (irAE) in the Top End of the Northern Territory and compare incidence between demographic subgroups.This retrospective, observational, cohort study collected data from electronic records of patients living in the Top End with solid organ cancer treated with immunotherapy between January 2016 and December 2021. The primary outcome was cumulative incidence of any-grade and severe irAE. Secondary outcomes were overall survival, treatment duration and reason for treatment discontinuation.Two hundred and twenty-six patients received immunotherapy. Forty-eight (21%) lived in a remote or very remote area, and 36 (16%) were Indigenous. Cumulative incidence of any-grade irAE was 54% (122/226 patients); incidence of severe irAE was 26% (59/226 patients). Rates were similar between Indigenous and non-Indigenous patients of any-grade (42% vs 56%, P = 0.11) and severe (11% vs 18%, P = 0.29) irAE. However, Indigenous patients had shorter treatment duration, more frequently discontinued treatment due to patient preference and appeared to have shorter median overall survival than non-Indigenous patients (17.1 vs 30.4 months; hazard ratio (HR) = 1.5, 95% confidence interval (CI) = 0.92-2.66). There was no difference in mortality between remote and urban patients (median overall survival 27.5 vs 30.2 months; HR = 1.1, 95% CI = 0.7-1.7).Rates of irAE in our cohort are comparable to those in the published literature. There was no significant difference in any-grade or severe irAE incidence observed between Indigenous and non-Indigenous patients.© 2024 The Author(s). Internal Medicine Journal published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Physicians.