Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.
Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
Oncologist. 2024 Jan 5;29(1):e118-e130. doi: 10.1093/oncolo/oyad238.
Immune-related adverse events (irAEs) constitute a challenge in the clinical management of solid tumors. This study aims to collect real-world data on the occurrence of immune-mediated diarrhea and colitis (IMDC) in advanced non-small cell lung cancer (aNSCLC) treated with immune checkpoint inhibitors (ICIs) and to assess the clinical impact of a multidisciplinary approach (MDA) on IMDC management.
We retrospectively collected data on patients with aNSCLC consecutively treated with ICIs, either as single agent or in combination with chemotherapy, between September 2013 and July 2022. Among patients developing IMDC, we conducted blinded revision of colonic biopsies and evaluated the clinical impact of the introduction of MDA through predefined indicators.
Among the 607 patients included, 84 (13.8%) experienced IMDC. Pathological review highlighted a high prevalence of microscopic colitis (28%), with a collagenous pattern linked to longer symptoms duration (P = .01). IMDC occurred more frequently in females (P = .05) and PD-L1 expressors (P = .014) and was correlated with longer progression-free survival (17.0 vs 5.8, P < .001) and overall survival (28.3 vs 9.5, P < .001). The introduction of MDA was associated with increased employment of diagnostical tools such as fecal calprotectin test (P < .001), colonoscopy (P < .001), and gastroenterological evaluation (P = .017) and a significant decrease in both grade 3 conversion rate (P = .046) and recurrence after rechallenge (P = .016). Hospitalization rate dropped from 17.2% to 3.8% (P: ns).
These findings highlight the clinical relevance of IMDC and support the incorporation of a MDA to optimize the clinical management of this irAE to improve patient care. Prospective validation has been planned.
免疫相关不良事件（irAEs）是实体瘤临床管理中的一个挑战。本研究旨在收集免疫检查点抑制剂（ICI）治疗晚期非小细胞肺癌（aNSCLC）中发生免疫介导性腹泻和结肠炎（IMDC）的真实世界数据，并评估多学科方法（MDA）对 IMDC 管理的临床影响。
我们回顾性地收集了 2013 年 9 月至 2022 年 7 月间连续接受 ICI 治疗的 aNSCLC 患者的数据，ICI 单药或联合化疗。在发生 IMDC 的患者中，我们对结肠活检进行了盲法复查，并通过预设指标评估 MDA 引入的临床影响。
在 607 例患者中，84 例（13.8%）发生 IMDC。病理复查显示显微镜下结肠炎的患病率较高（28%），胶原模式与更长的症状持续时间相关（P=0.01）。IMDC 更常见于女性（P=0.05）和 PD-L1 表达者（P=0.014），与更长的无进展生存期（17.0 与 5.8，P<0.001）和总生存期（28.3 与 9.5，P<0.001）相关。MDA 的引入与更多地使用诊断工具相关，如粪便钙卫蛋白检测（P<0.001）、结肠镜检查（P<0.001）和胃肠病学评估（P=0.017），以及 3 级转化率（P=0.046）和再挑战后复发率（P=0.016）显著降低。住院率从 17.2%降至 3.8%（P：无统计学意义）。
这些发现强调了 IMDC 的临床相关性，并支持采用 MDA 来优化该 irAE 的临床管理，以改善患者的护理。已经计划了前瞻性验证。
