Watson Sutton, Marx Justin Bradley
University of Tennessee Medical Center, Knoxville, Tennessee.
Prisma Health Upstate - Cancer Institute, Greenville, South Carolina.
J Adv Pract Oncol. 2019 Nov-Dec;10(8):883-888. doi: 10.6004/jadpro.2019.10.8.10. Epub 2019 Nov 1.
Mogamulizumab-kpkc provides a novel mechanism of action for the treatment of mycosis fungoides and Sézary syndrome. The efficacy and safety of mogamulizumab-kpkc for the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome were demonstrated in a multicenter, open-label, randomized phase III trial comparing mogamulizumab-kpkc with vorinostat. Patients treated with mogamulizumab-kpkc showed a statistically significant increased progression-free survival (PFS; 7.7 months) compared with vorinostat (3.1 months). Overall response rates were higher with mogamulizumab-kpkc compared with vorinostat (28% vs. 5%; < .0001). The most common adverse events (> 20%) associated with mogamulizumab-kpkc include rash, infusion-related reaction, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. The use of mogamulizumab-kpkc up to 50 days prior to allogeneic hematopoietic stem cell transplantation has been associated with an increased risk of severe acute graft-vs.-host disease, steroid-refractory graft-vs.-host disease, and mortality. Additional labeled warnings include dermatologic toxicity, infection, and autoimmune complications. The overall benefit to risk assessment of mogamulizumab-kpkc is acceptable, but its use is constrained by the high cost of treatment and the short-term benefit.
莫加穆利单抗-kpkc为蕈样肉芽肿和塞扎里综合征的治疗提供了一种新的作用机制。在一项比较莫加穆利单抗-kpkc与伏立诺他的多中心、开放标签、随机III期试验中，证明了莫加穆利单抗-kpkc治疗复发或难治性蕈样肉芽肿和塞扎里综合征的疗效和安全性。与伏立诺他（3.1个月）相比，接受莫加穆利单抗-kpkc治疗的患者无进展生存期（PFS；7.7个月）有统计学显著提高。与伏立诺他相比，莫加穆利单抗-kpkc的总体缓解率更高（28%对5%；P<0.0001）。与莫加穆利单抗-kpkc相关的最常见不良事件（>20%）包括皮疹、输液相关反应、疲劳、腹泻、肌肉骨骼疼痛和上呼吸道感染。在异基因造血干细胞移植前50天内使用莫加穆利单抗-kpkc与严重急性移植物抗宿主病、类固醇难治性移植物抗宿主病和死亡率增加的风险相关。其他标签警告包括皮肤毒性、感染和自身免疫并发症。莫加穆利单抗-kpkc的总体风险效益评估是可以接受的，但其使用受到治疗成本高和短期效益的限制。
