Mao Yun-Tao, Wang Ying, Chen Xiao-Xiao, Liu Cheng-Jiang, Bao Qi
Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
J Cosmet Dermatol. 2024 Apr;23(4):1165-1177. doi: 10.1111/jocd.16105. Epub 2023 Nov 27.
BACKGROUND: Immune checkpoint inhibitors (ICIs) have advanced the therapeutic landscape for malignant melanoma patients. However, they can cause permanent and irreversible dermatologic immune-related adverse events (irAEs) that may lead to interruption of ICI treatment or become life-threatening. To assess the risk of severe dermatologic irAEs (grade 3 or higher) among ICIs for advanced melanoma, we conducted a network meta-analysis (NMA). METHODS: Phase II/III randomized controlled clinical trials (RCTs) involving ICIs were retrieved from various databases, including PubMed, Embase, Cochrane Library, and Web of Science. These trials were published from the inception of databases to October 15, 2022. In addition, the risk of severe dermatologic irAEs associated with ICI types and doses was evaluated and compared by NMA. RESULTS: This study included 20 Phase II/III RCTs with a total of 10 575 patients. The results indicated that ICIs carry a higher risk of severe dermatologic irAEs compared to chemotherapy. Additionally, the combinational therapy of Nivolumab + Ipilimumab was associated with a higher risk than ICI monotherapy. Comparatively, the latest treatment option involving dual ICI therapy with Relatlimab + Nivolumab showed a lower toxicity risk, but higher than Ipilimumab alone. Lastly, Nivolumab, at a dose of 3 mg/kg every 2 weeks, was observed as the lowest-risk dosing regimen for severe dermatologic irAEs in patients with advanced melanoma. CONCLUSION: The findings suggest that Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) administered every 3 weeks should be used cautiously in patients with advanced melanoma at high risk for dermatologic irAEs. While we recommend the preferred regimen of Nivolumab (dose = 3 mg/kg, every 2 weeks).
背景：免疫检查点抑制剂（ICIs）改善了恶性黑色素瘤患者的治疗前景。然而，它们可引发永久性和不可逆的皮肤免疫相关不良事件（irAEs），这可能导致ICI治疗中断或危及生命。为评估晚期黑色素瘤患者使用ICIs治疗时发生严重皮肤irAEs（3级或更高）的风险，我们进行了一项网状荟萃分析（NMA）。 方法：从多个数据库检索了涉及ICIs的II/III期随机对照临床试验（RCTs），包括PubMed、Embase、Cochrane图书馆和Web of Science。这些试验自数据库建立至2022年10月15日发表。此外，通过NMA评估并比较了与ICI类型和剂量相关的严重皮肤irAEs风险。 结果：本研究纳入了20项II/III期RCTs，共10575例患者。结果表明，与化疗相比，ICIs发生严重皮肤irAEs的风险更高。此外，纳武利尤单抗+伊匹木单抗联合治疗比ICI单药治疗的风险更高。相比之下，最新的Relatlimab+纳武利尤单抗双ICI治疗方案显示出较低的毒性风险，但高于伊匹木单抗单药治疗。最后，观察到每2周一次剂量为3mg/kg的纳武利尤单抗是晚期黑色素瘤患者严重皮肤irAEs风险最低的给药方案。 结论：研究结果表明，对于有高皮肤irAEs风险的晚期黑色素瘤患者，应谨慎使用每3周一次的纳武利尤单抗（1mg/kg）+伊匹木单抗（3mg/kg）。我们推荐首选方案为纳武利尤单抗（剂量=3mg/kg，每2周一次）。
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