Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA; Department of Dermatology, Weill Cornell Medicine, New York, USA.
Ann Oncol. 2021 Jun;32(6):736-745. doi: 10.1016/j.annonc.2021.02.016. Epub 2021 Mar 3.
Immunoglobulin E (IgE) blockade with omalizumab has demonstrated clinical benefit in pruritus-associated dermatoses (e.g. atopic dermatitis, bullous pemphigoid, urticaria). In oncology, pruritus-associated cutaneous adverse events (paCAEs) are frequent with immune checkpoint inhibitors (CPIs) and targeted anti-human epidermal growth factor receptor 2 (HER2) therapies. Thus, we sought to evaluate the efficacy and safety of IgE blockade with omalizumab in cancer patients with refractory paCAEs related to CPIs and anti-HER2 agents.
Patients included in this multicenter retrospective analysis received monthly subcutaneous injections of omalizumab for CPI or anti-HER2 therapy-related grade 2/3 pruritus that was refractory to topical corticosteroids plus at least one additional systemic intervention. To assess clinical response to omalizumab, we used the Common Terminology Criteria for Adverse Events version 5.0. The primary endpoint was defined as reduction in the severity of paCAEs to grade 1/0.
A total of 34 patients (50% female, median age 67.5 years) received omalizumab for cancer therapy-related paCAEs (71% CPIs; 29% anti-HER2). All had solid tumors (29% breast, 29% genitourinary, 15% lung, 26% other), and most (n = 18, 64%) presented with an urticarial phenotype. In total 28 of 34 (82%) patients responded to omalizumab. The proportion of patients receiving oral corticosteroids as supportive treatment for management of paCAEs decreased with IgE blockade, from 50% to 9% (P < 0.001). Ten of 32 (31%) patients had interruption of oncologic therapy due to skin toxicity; four of six (67%) were successfully rechallenged following omalizumab. There were no reports of anaphylaxis or hypersensitivity reactions related to omalizumab.
IgE blockade with omalizumab demonstrated clinical efficacy and was well tolerated in cancer patients with pruritus related to CPIs and anti-HER2 therapies.
奥马珠单抗对免疫球蛋白 E（IgE）的阻断已在瘙痒相关皮肤病（如特应性皮炎、大疱性类天疱疮、荨麻疹）中显示出临床益处。在肿瘤学中，免疫检查点抑制剂（CPIs）和靶向抗人表皮生长因子受体 2（HER2）治疗常伴有瘙痒相关皮肤不良反应（paCAEs）。因此，我们旨在评估奥马珠单抗治疗 CPIs 和抗 HER2 相关药物引起的难治性 paCAEs 中对癌症患者的疗效和安全性。
纳入本多中心回顾性分析的患者接受奥马珠单抗每月皮下注射，用于治疗 CPIs 或抗 HER2 治疗相关的 2/3 级瘙痒，这些瘙痒对局部皮质类固醇加至少一种其他全身干预措施耐药。为评估奥马珠单抗的临床反应，我们使用了不良事件通用术语标准 5.0。主要终点定义为 paCAEs 严重程度降至 1/0 级。
共 34 例患者（50%为女性，中位年龄 67.5 岁）因癌症治疗相关 paCAEs（71%为 CPIs；29%为抗 HER2）接受奥马珠单抗治疗。所有患者均患有实体瘤（29%为乳腺癌，29%为泌尿生殖系统肿瘤，15%为肺癌，15%为其他肿瘤），大多数（n=18，64%）表现为荨麻疹样表现。奥马珠单抗治疗后，共有 28 例（82%）患者有应答。随着 IgE 阻断，接受口服皮质类固醇作为瘙痒管理支持治疗的患者比例从 50%降至 9%（P < 0.001）。因皮肤毒性中断肿瘤治疗的患者有 10 例（32%）；6 例中有 4 例（67%）在奥马珠单抗治疗后成功重新用药。没有与奥马珠单抗相关的过敏反应或过敏样反应报告。
奥马珠单抗对 CPIs 和抗 HER2 治疗相关瘙痒的癌症患者具有临床疗效且耐受性良好。
