Department of Dermatology, University Hospital of Muenster, Muenster, Germany.
Dermatological Office Professor Schiller, Coesfeld, Germany.
J Eur Acad Dermatol Venereol. 2017 Nov;31(11):1841-1847. doi: 10.1111/jdv.14366. Epub 2017 Jul 20.
This open-label, multicenter, dose-escalation study evaluated the safety, tolerability, and efficacy of subcutaneous pegylated (40 kD) interferon α-2a (PEG-IFN α-2a) in patients with cutaneous T-cell lymphoma (CTCL).
PEG-IFN α-2a was administered subcutaneously at 180 (n = 4), 270 (n = 6), or 360 μg (n = 3) once weekly for 12 weeks. Efficacy was assessed by the proportion of patients with complete response (CR) or partial response (PR).
PEG-IFN α-2a was generally well tolerated, with a moderate number of reductions or withholding of doses because of adverse events (AEs) (25% (n = 1), 66% (n = 4), and 0% (n = 0) in the 180-, 270-, and 360-μg/week groups, respectively). The only dose-limiting toxicity was a grade 3 elevation of liver enzymes in the 270-μg dose group. The most common AEs were fatigue, acute flu-like symptoms, and hepatic toxicity. The major response rate (CR or PR) was 50% in the 180-μg group (CR, 50%; PR, 0%), 83% in the 270-μg group (CR, 67%; PR, 17%), and 66% in the 360-μg group (CR, 33%; PR, 33%).
PEG-IFN α-2a at doses up to 360 μg once weekly was well tolerated in patients with CTCL up to the highest dose group and showed good response rates. Due to their good tolerance even in high doses, they might be an option for patients not tolerating standard IFN-α preparations. However, for this purpose and to evaluate comparability between standard and PEG-IFN larger clinical trials are needed, alone and in combination with oral photochemotherapy (PUVA).
这项开放标签、多中心、剂量递增研究评估了皮下聚乙二醇（40 kD）干扰素 α-2a（PEG-IFN α-2a）在皮肤 T 细胞淋巴瘤（CTCL）患者中的安全性、耐受性和疗效。
PEG-IFN α-2a 每周一次皮下注射 180（n = 4）、270（n = 6）或 360 μg（n = 3），共 12 周。通过完全缓解（CR）或部分缓解（PR）患者的比例评估疗效。
PEG-IFN α-2a 通常具有良好的耐受性，因不良反应（AE）而减少或停止剂量的患者比例适中（180、270 和 360 μg/周组分别为 25%（n = 1）、66%（n = 4）和 0%（n = 0））。唯一的剂量限制性毒性是 270 μg 剂量组的肝酶 3 级升高。最常见的 AE 是疲劳、急性流感样症状和肝毒性。主要缓解率（CR 或 PR）在 180 μg 组为 50%（CR，50%；PR，0%），270 μg 组为 83%（CR，67%；PR，17%），360 μg 组为 66%（CR，33%；PR，33%）。
PEG-IFN α-2a 每周高达 360 μg 的剂量在最高剂量组的 CTCL 患者中耐受性良好，且显示出良好的缓解率。由于即使在高剂量下也具有良好的耐受性，它们可能是不能耐受标准 IFN-α 制剂的患者的一种选择。然而，出于此目的，并为了评估标准和 PEG-IFN 之间的可比性，需要进行更大规模的临床试验，单独使用或与口服光化学疗法（PUVA）联合使用。
