Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Department of Medical Oncology, Sidney Kimmel Center, Thomas Jefferson University, Philadelphia, PA.
Clinical Outcomes Solutions, Tucson, AZ.
Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):97-105. doi: 10.1016/j.clml.2020.09.003. Epub 2020 Sep 18.
Sézary syndrome (SS) and mycosis fungoides (MF), 2 types of cutaneous T-cell lymphoma, cause significant morbidity and adversely affect patients' quality of life (QoL). The present study assessed the QoL measurement changes in patients receiving mogamulizumab versus vorinostat.
A multicenter phase III trial was conducted of patients with stage IB-IV MF/SS with ≥ 1 failed systemic therapy. The QoL measures included Skindex-29 and the Functional Assessment of Cancer Therapy-General. The symptoms, function, and QoL subdomains were longitudinally modeled using mixed models with prespecified covariates. Meaningful change thresholds (MCTs) were defined using distribution-based methods. The categorical changes by group over time and the time to clinically meaningful worsening were analyzed.
Of the 372 randomized patients, mogamulizumab demonstrated improvement in Skindex-29 symptoms (cycles 3, 5, and 7; P < .05) and functional (cycles 3 and 5; P < .05) scales. A significantly greater proportion of mogamulizumab-treated patients improved by MCTs or more from baseline in the Skindex-29 symptoms domain (cycles 3, 5, 7, and 11) and functioning domain (cycle 5). Significant differences in the Functional Assessment of Cancer Therapy-General physical well-being (cycles 1, 3, and 5; P < .05) were observed in favor of mogamulizumab and a greater proportion of patients had declined by MCTs or more at cycles 1, 3, 5, and 7 with vorinostat treatment. The median time to symptom worsening using Skindex-29 was 27.4 months for mogamulizumab versus 6.6 months for vorinostat. In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains. The time to worsening was similar for the 2 MF treatment arms.
The symptoms, function, and overall QoL of patients with MF/SS favored mogamulizumab over vorinostat across all time points. Patients with the greatest symptom burden and functional impairment derived the most QoL benefit from mogamulizumab.
蕈样肉芽肿（MF）和塞扎里综合征（SS）是两种皮肤 T 细胞淋巴瘤，会导致严重的发病率并对患者的生活质量（QoL）产生不利影响。本研究评估了接受莫格利珠单抗与伏立诺他治疗的患者的 QoL 测量变化。
进行了一项多中心 III 期试验，纳入了 1 种以上系统性治疗失败的 IB-IV 期 MF/SS 患者。QoL 测量包括 Skindex-29 和癌症治疗功能评估一般量表。使用具有预设协变量的混合模型对症状、功能和 QoL 子域进行纵向建模。使用基于分布的方法定义有意义的变化阈值（MCT）。分析了随时间推移的组间分类变化和临床意义上恶化的时间。
在 372 名随机患者中，莫格利珠单抗在 Skindex-29 症状（第 3、5 和 7 周期；P<.05）和功能（第 3 和 5 周期；P<.05）量表方面均有改善。与基线相比，接受莫格利珠单抗治疗的患者在 Skindex-29 症状（第 3、5、7 和 11 周期）和功能（第 5 周期）领域中通过 MCT 或更多的改善比例显著更高。在癌症治疗功能评估一般身体状况方面（第 1、3 和 5 周期；P<.05），观察到莫格利珠单抗的差异有统计学意义，而在伏立诺他治疗中，有更多的患者在第 1、3、5 和 7 周期通过 MCT 或更多的下降。使用 Skindex-29 评估症状恶化的中位时间为莫格利珠单抗 27.4 个月，伏立诺他 6.6 个月。在 SS 患者中，莫格利珠单抗的恶化时间更有利（P<.005），Skindex-29 的所有领域均如此。2 种 MF 治疗组的恶化时间相似。
在所有时间点，MF/SS 患者的症状、功能和整体 QoL 均倾向于莫格利珠单抗而非伏立诺他。症状负担和功能障碍最大的患者从莫格利珠单抗中获得最大的 QoL 获益。
