Fong Sophia, Hong Eric K, Khodadoust Michael S, Li Shufeng, Hoppe Richard T, Kim Youn H, Hiniker Susan M
Department of Dermatology, Stanford University, Stanford, California.
Department of Medicine, Division of Medical Oncology, Stanford University, Stanford, California.
Adv Radiat Oncol. 2020 Nov 26;6(3):100629. doi: 10.1016/j.adro.2020.11.014. eCollection 2021 May-Jun.
Management of patients with refractory mycosis fungoides and Sézary syndrome (SS) is often challenging, as available therapies lack durable response and consistent activity across disease compartments. Combining low-dose total skin electron beam therapy (LD-TSEBT) upfront with mogamulizumab could optimize the clinical outcome of these patients. LD-TSEBT is effective in clearing skin disease, and mogamulizumab is an antitumor immunotherapy with long-term tolerability, suggesting its potential as a maintenance therapy after maximal response. We examine the combination regimen in patients with SS who were previously treated.
Two patients with SS were treated with combination LD-TSEBT and mogamulizumab. Both patients received mogamulizumab 1 mg/kg weekly × 4 and then bi-weekly; LD-TSEBT (12 Gy) was initiated within 2 days of starting mogamulizumab and given over 2-3 weeks. Safety and clinical response were evaluated.
Total skin electron beam therapy plus mogamulizumab (TSE-Moga) was well-tolerated without any unanticipated adverse events. Patient 1 (T4N2bM0B2) was a 63-year-old woman with 4 prior systemic therapies; time to global response with TSE-Moga was 9 weeks. Patient 2 (T4NxM0B2) was a 75-year-old man with 5 prior systemic therapies; time to global response was 4 weeks. Both patients lacked global response to their prior therapies but achieved global complete response (blood and skin) with TSE-Moga. After a follow-up of 72 weeks and 43 weeks, respectively, global complete response continued.
TSE-Moga demonstrated excellent tolerability and promising clinical activity with ongoing global complete responses in 2 patients with refractory SS. This encouraging experience supports our ongoing clinical trial evaluating the efficacy and safety of TSE-Moga in mycosis fungoides and SS.
难治性蕈样肉芽肿和 Sézary 综合征（SS）患者的管理通常具有挑战性，因为现有疗法缺乏持久反应且在疾病各部分的活性不一致。将低剂量全身电子束治疗（LD-TSEBT）与莫加莫拉单抗联合作为初始治疗可能会优化这些患者的临床结局。LD-TSEBT 对清除皮肤病有效，而莫加莫拉单抗是一种具有长期耐受性的抗肿瘤免疫疗法，提示其作为最大反应后维持治疗的潜力。我们研究了该联合方案在既往接受过治疗的 SS 患者中的应用。
两名 SS 患者接受了 LD-TSEBT 与莫加莫拉单抗联合治疗。两名患者均接受莫加莫拉单抗 1 mg/kg，每周 1 次，共 4 次，然后每两周 1 次；LD-TSEBT（12 Gy）在开始使用莫加莫拉单抗的 2 天内开始，并在 2 - 3 周内给予。评估安全性和临床反应。
全身电子束治疗加莫加莫拉单抗（TSE-Moga）耐受性良好，未出现任何意外不良事件。患者 1（T4N2bM0B2）是一名 63 岁女性，既往接受过 4 次全身治疗；TSE-Moga 治疗至总体缓解的时间为 9 周。患者 2（T4NxM0B2）是一名 75 岁男性，既往接受过 5 次全身治疗；至总体缓解的时间为 4 周。两名患者对既往治疗均未达到总体缓解，但 TSE-Moga 治疗后均达到总体完全缓解（血液和皮肤）。分别随访 72 周和 43 周后，总体完全缓解持续存在。
TSE-Moga 在两名难治性 SS 患者中显示出极佳的耐受性和有前景的临床活性，且总体完全缓解持续存在。这一令人鼓舞的经验支持我们正在进行的评估 TSE-Moga 在蕈样肉芽肿和 SS 中的疗效和安全性的临床试验。
