Background/Objectives: The landscape of advanced melanoma treatments has shifted dramatically in recent years. Target therapy and immunotherapy have changed the management of patients with both metastatic (stage IV according to AJCC 8th ed.) and nodal (stage IIB/C and III) disease. As the use of novel agents has increased, so have the cutaneous toxicities associated with these medications. While most skin reactions are low-grade and can be managed conservatively with topical therapies, high-grade or life-threatening drug reactions can arise during therapy, requiring prompt dermatologic recognition and treatment. Given the survival benefit attributed to these new agents, treating skin toxicity and maintaining a patient’s quality of life is of paramount importance. Methods: We undertook a prospective, monocentric, and descriptive study in Bologna, Italy, including patients referred to the Oncologic Dermatology Unit of IRCCS AOU of Bologna who developed biopsy-proven cutaneous adverse events (AE) under treatment with immunotherapy for cutaneous melanoma with nodal (stage IIB/C, III) and metastatic (stage IV) disease from January 2016 to April 2024. Results: In 202 identified patients, 75 (37.5%) developed skin AEs. Ipilimumab was causal for 48.1% of skin AEs, followed by nivolumab (37%) and pembrolizumab (31.4%). Recorded types of skin AEs included erythematous rash, vitiligo, alopecia, lichenoid, maculopapular, acneiform, urticarial, psoriasiform, granulomatous, eczematous, and severe cutaneous AEs, such as Erythema multiforme/Stevens-Johnson syndrome and bullous autoimmune dermatoses. Most AEs were low-grade [CTCAE 1–2] (97%) and typically occurred after 10 weeks of treatment. Conclusions: This study comprehensively describes skin AEs occurring during systemic treatment with ICIs for cutaneous melanoma at a single center.
背景/目的：近年来，晚期黑色素瘤的治疗格局发生了巨大变化。靶向治疗和免疫治疗改变了转移性（根据AJCC第8版为IV期）及淋巴结转移性（IIB/C期和III期）黑色素瘤患者的治疗模式。随着新型药物的广泛应用，与之相关的皮肤毒性反应也日益增多。虽然大多数皮肤反应为低级别，可通过局部治疗进行保守处理，但在治疗过程中仍可能出现高级别甚至危及生命的药物反应，需要皮肤科医生及时识别并处理。鉴于这些新药带来的生存获益，有效治疗皮肤毒性并维持患者生活质量至关重要。方法：我们在意大利博洛尼亚开展了一项前瞻性、单中心描述性研究，纳入2016年1月至2024年4月期间在博洛尼亚IRCCS AOU肿瘤皮肤病科就诊的皮肤黑色素瘤患者，这些患者在淋巴结转移（IIB/C期、III期）和转移性（IV期）疾病接受免疫治疗期间，经活检证实出现了皮肤不良事件。结果：在202例确诊患者中，75例（37.5%）出现了皮肤不良事件。其中伊匹单抗引起的皮肤不良事件占48.1%，其次是纳武利尤单抗（37%）和帕博利珠单抗（31.4%）。记录的皮肤不良事件类型包括红斑性皮疹、白癜风、脱发、苔藓样疹、斑丘疹、痤疮样疹、荨麻疹样疹、银屑病样疹、肉芽肿性皮炎、湿疹样疹，以及严重皮肤不良事件如多形红斑/史蒂文斯-约翰逊综合征和大疱性自身免疫性皮肤病。绝大多数不良事件为低级别[CTCAE 1-2级]（97%），通常发生在治疗10周后。结论：本研究全面描述了单中心接受免疫检查点抑制剂全身治疗的皮肤黑色素瘤患者发生的皮肤不良事件。
肿瘤(癌症)患者之家