Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Division of Oncology, Department of Medicine, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
J Immunother Cancer. 2021 Sep;9(9). doi: 10.1136/jitc-2021-002886.
In 2017, Massachusetts General Hospital implemented the Severe Immunotherapy Complications (SIC) Service, a multidisciplinary care team for patients hospitalized with immune-related adverse events (irAEs), a unique spectrum of toxicities associated with immune checkpoint inhibitors (ICIs). This study's objectives were to evaluate the intervention's (1) effect on patient outcomes and healthcare utilization, and (2) ability to collect biological samples via a central infrastructure, in order to study the mechanisms responsible for irAEs.
A hospital database was used to identify patients who received ICIs for a malignancy and were hospitalized with severe irAEs, before (April 2, 2016-October 3, 2017) and after (October 3, 2017-October 24, 2018) SIC Service initiation. The primary outcome was readmission rate after index hospitalization. Secondary outcomes included length of stay (LOS) for admissions, corticosteroid and non-steroidal second-line immunosuppression use, ICI discontinuation, and inpatient mortality.
In the pre-SIC period, 127 of 1169 patients treated with ICIs were hospitalized for irAEs; in the post-SIC period, 122 of 1159. After SIC service initiation, reductions were observed in irAE readmission rate (14.8% post-SIC vs 25.9% pre-SIC; OR 0.46; 95% CI 0.22 to 0.95; p=0.036) and readmission LOS (median 6 days post-SIC vs 7 days pre-SIC; 95% CI -16.03 to -0.14; p=0.046). No significant pre-initiation and post-initiation differences were detected in corticosteroid use, second-line immunosuppression, ICI discontinuation, or inpatient mortality rates. The SIC Service collected 789 blood and tissue samples from 234 patients with suspected irAEs.
This is the first study to report that establishing a highly subspecialized care team focused on irAEs is associated with improved patient outcomes and reduced healthcare utilization. Furthermore, the SIC Service successfully integrated blood and tissue collection safety into routine care.
2017 年，马萨诸塞州综合医院实施了严重免疫治疗并发症（SIC）服务，这是一个多学科的护理团队，负责治疗因免疫相关不良反应（irAEs）而住院的患者，这是一种与免疫检查点抑制剂（ICIs）相关的独特毒性谱。本研究的目的是评估该干预措施：（1）对患者结局和医疗保健利用的影响；（2）通过中央基础设施收集生物样本的能力，以便研究导致 irAEs 的机制。
使用医院数据库，确定在 SIC 服务启动之前（2016 年 4 月 2 日至 2017 年 10 月 3 日）和之后（2017 年 10 月 3 日至 2018 年 10 月 24 日）因恶性肿瘤接受 ICI 治疗并因严重 irAEs 住院的患者，作为原发性研究结果的指标住院患者出院后的再入院率。次要结局包括入院时的住院时间（LOS）、皮质类固醇和非皮质类固醇二线免疫抑制药物的使用、ICI 停药和住院死亡率。
在 SIC 前期间，1169 例接受 ICI 治疗的患者中有 127 例因 irAEs 住院；在 SIC 后期间，1159 例中有 122 例。在 SIC 服务启动后，irAE 再入院率（SIC 后为 14.8%，SIC 前为 25.9%；OR 0.46；95%CI 0.22 至 0.95；p=0.036）和再入院 LOS（中位数 SIC 后为 6 天，SIC 前为 7 天；95%CI -16.03 至 -0.14；p=0.046）均有所降低。在皮质类固醇使用、二线免疫抑制药物、ICI 停药或住院死亡率方面，未发现 SIC 服务启动前和启动后的显著差异。SIC 服务从 234 例疑似 irAEs 患者中收集了 789 份血液和组织样本。
这是第一项报道建立专门针对 irAEs 的高度专业化护理团队与改善患者结局和降低医疗保健利用相关的研究。此外，SIC 服务成功地将血液和组织采集安全纳入常规护理。
