Medical Oncology 2, IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genoa, Genova, Italy.
Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genoa, Genova, Italy.
ESMO Open. 2023 Feb;8(1):100791. doi: 10.1016/j.esmoop.2023.100791. Epub 2023 Feb 13.
BACKGROUND: Immune checkpoint inhibitors (ICIs) have revolutionized the management of multiple tumors, due to improved efficacy, quality of life, and safety. While most immune-related adverse events (irAEs) are mild and easily managed, in rare cases such events may be life-threatening, especially those affecting the neuromuscular and cardiac system. The management of neuromuscular/cardiac irAEs is not clear due to the lack of consistent data. Therefore, we carried out a pooled analysis of collected cases from selected Italian centers and individual data from published case reports and case series, in order to improve our understanding of these irAEs. PATIENTS AND METHODS: We collected retrospective data from patients treated in six Italian centers with ICIs (programmed cell death protein 1 or programmed death-ligand 1 and/or cytotoxic T-lymphocyte antigen 4 inhibitor) for any solid tumor who experienced neuromuscular and/or cardiovascular toxicity. Then, we carried out a search of case reports and series of neuromuscular/cardiac irAEs from ICIs with any solid tumor. RESULTS: This analysis includes cases from Italian institutions (n = 18) and the case reports identified in our systematic literature search (n = 120), for a total of 138 patients. Among these patients, 50 (36.2%) had complete resolution of their neuromuscular/cardiac irAEs, in 21 (15.2%) cases there was a clinical improvement with mild sequelae, and 53 (38.4%) patients died as a result of the irAEs. Factors significantly associated with worse outcomes were early irAE onset, within the first two cycles of ICI (Fisher P < 0.0001), clinical manifestation of both myositis and myocarditis when compared with patients who developed only myositis or myocarditis (chi-square P = 0.0045), and the development of arrhythmia (Fisher P = 0.0070). CONCLUSIONS: To the best of our knowledge, this is the largest collection of individual cases of immune-related myocarditis/myositis. Early irAE onset, concurrent development of myositis and myocarditis, as well as occurrence of arrhythmias are associated with worse outcomes and should encourage an aggressive immunomodulatory treatment.
背景：免疫检查点抑制剂（ICIs）由于提高了疗效、生活质量和安全性，从而彻底改变了多种肿瘤的治疗方式。虽然大多数免疫相关不良事件（irAEs）是轻微且易于管理的，但在极少数情况下，这些事件可能会危及生命，尤其是那些影响神经肌肉和心脏系统的事件。由于缺乏一致的数据，因此，神经肌肉/心脏 irAEs 的管理尚不清楚。因此，我们对来自选定的意大利中心的收集病例和已发表的病例报告和病例系列中的个体数据进行了汇总分析，以提高对这些 irAEs 的认识。
患者和方法：我们从意大利六家接受免疫检查点抑制剂（程序性细胞死亡蛋白 1 或程序性死亡配体 1 和/或细胞毒性 T 淋巴细胞相关抗原 4 抑制剂）治疗任何实体瘤的患者中收集了回顾性数据，这些患者经历了神经肌肉和/或心血管毒性。然后，我们对来自任何实体瘤的免疫检查点抑制剂引起的神经肌肉/心脏 irAEs 的病例报告和系列进行了检索。
结果：这项分析包括来自意大利机构的病例（n=18）和我们系统文献检索中确定的病例报告（n=120），共 138 例患者。在这些患者中，50 例（36.2%）的神经肌肉/心脏 irAEs 完全缓解，21 例（15.2%）患者的 irAEs 有临床改善但伴有轻微后遗症，53 例（38.4%）患者因 irAEs 而死亡。与 irAEs 结局较差相关的因素是 irAE 早期发作，即在 ICI 的前两个周期内（Fisher P<0.0001），与仅发生肌炎或心肌炎的患者相比，同时发生肌炎和心肌炎的临床表现（卡方检验 P=0.0045），以及心律失常的发生（Fisher P=0.0070）。
结论：据我们所知，这是最大的免疫相关心肌炎/肌炎个体病例集。irAE 早期发作、同时发生肌炎和心肌炎以及心律失常的发生与较差的结局相关，应鼓励进行积极的免疫调节治疗。
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