Background: Current treatment guidelines for moderate to severe colitis (IMC) secondary to immune checkpoint inhibitors (ICI) recommend systemic corticosteroids as the primary therapy in conjunction with biologics, namely infliximab and/or vedolizumab. We aimed to explore the efficacy and safety of oral budesonide in the treatment of IMC. Methods: We performed a retrospective analysis at MD Anderson Cancer Center of adult cancer patients with a confirmed (based on clinical, radiographic and laboratory assessment) diagnosis of IMC between 1 January 2015 and 31 November 2022, treated with budesonide. Data collection included demographics, oncologic history, IMC-related information and outcomes up to 6 months after the last dose of ICI. Results: Our sample (n = 69) comprised primarily of Caucasian (76.8%) females (55.1%). The majority of patients received combination therapy with anti-PD-1/L1 and anti-CTLA-4 (49.3%), and the most common malignancy treated was melanoma (37.6%). The median grade of diarrhea was 3 and of colitis was 2. Of the 50 patients who underwent endoscopic evaluation, a majority had non-ulcerative inflammation (64%) and active colitis on histology (78%). Budesonide was used as primary treatment at onset of IMC in 56.5% patients, as well as a bridging therapy from systemic corticosteroids in 33.3%. Less than half of the patients (44.9%) required additional therapies such as biologics or fecal microbiota transplant. Additionally, 75.3% of patients achieved full remission of IMC and 24.6% had a recurrence of IMC. ICI was resumed in 31.9% of patients and 17.4% received other forms of cancer therapies. Conclusions: Budesonide may be an effective strategy to treat and prevent the recurrence of IMC. The remission rates observed in our analysis with budesonide alone are comparable to systemic corticosteroids. Patients that require an extended duration of steroid exposure and those with moderate to severe colitis may benefit from budesonide given its lower risk of infection and complications. Furthermore, we observe that budesonide may serve as a successful bridge from systemic corticosteroids with subsequent biologic treatment. Larger prospective studies are necessary to determine the role of budesonide as well as its safety profile.
背景：目前针对免疫检查点抑制剂（ICI）继发的中重度结肠炎（IMC）的治疗指南推荐全身性皮质类固醇作为主要疗法，并联合生物制剂（即英夫利西单抗和/或维多珠单抗）。本研究旨在探讨口服布地奈德治疗IMC的疗效与安全性。方法：我们在MD安德森癌症中心对2015年1月1日至2022年11月31日期间经临床、影像学及实验室评估确诊为IMC并接受布地奈德治疗的成年癌症患者进行回顾性分析。数据收集涵盖人口统计学特征、肿瘤病史、IMC相关信息以及末次ICI给药后6个月内的临床结局。结果：研究样本（n=69）以高加索人种（76.8%）和女性患者（55.1%）为主。多数患者接受抗PD-1/L1联合抗CTLA-4治疗（49.3%），最常见的基础恶性肿瘤为黑色素瘤（37.6%）。腹泻中位严重程度为3级，结肠炎为2级。在接受内镜评估的50例患者中，多数表现为非溃疡性炎症（64%）和组织学活动性结肠炎（78%）。56.5%的患者在IMC发作时将布地奈德作为初始治疗，33.3%的患者将其作为全身性皮质类固醇的桥接治疗。不足半数患者（44.9%）需要额外治疗（如生物制剂或粪便微生物移植）。75.3%的患者实现IMC完全缓解，24.6%出现IMC复发。31.9%的患者重启ICI治疗，17.4%接受其他形式的癌症治疗。结论：布地奈德可能是治疗并预防IMC复发的有效策略。本研究中单用布地奈德的缓解率与全身性皮质类固醇相当。对于需要延长类固醇暴露时间及中重度结肠炎患者，布地奈德因其较低的感染和并发症风险可能更具优势。此外，布地奈德可作为全身性皮质类固醇向后续生物治疗的成功桥接手段。未来需要更大规模的前瞻性研究以明确布地奈德的治疗地位及安全性特征。
肿瘤(癌症)患者之家