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聚乙二醇干扰素-α2a 在皮肤 T 细胞淋巴瘤中的应用 - 一项 70 例患者的多中心回顾性数据分析。

Pegylated interferon-α2a in cutaneous T-cell lymphoma - a multicenter retrospective data analysis with 70 patients.

机构信息

Department of Dermatology and Venereology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Department of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany.

出版信息

J Dtsch Dermatol Ges. 2024 Nov;22(11):1489-1497. doi: 10.1111/ddg.15511. Epub 2024 Oct 2.

Abstract

BACKGROUND

Interferon-alpha is an important therapeutic option for the treatment of the cutaneous T-cell lymphomas (CTCL). Since the approved recombinant interferon-α-2a (IFN-α2a) has no longer been produced since January 2020, pegylated interferon-α2a (pegIFN-α2a) can be used as an alternative treatment, even though it is not approved for the treatment of CTCL. The aim of this multicentre study was to generate comprehensive data on the efficacy and tolerability of pegIFN-α2a in the treatment of CTCL.

PATIENTS AND METHODS

A multicenter retrospective study was conducted with 70 patients with CTCL from twelve German skin centers.

RESULTS

In total, 70 patients were included in the study, with 57.2% male and a mean age of 58.8 ± 14.9 years. Mycosis fungoides was present in 71.4% of cases and Sézary Syndrome in 28.6%. An overall response rate of 55.2% was observed with pegIFNα-2a therapy. In 50% of cases, therapy was discontinued after 63.6 ± 33.5 weeks. The most common reason for discontinuation was adverse events, which occurred in 68.6% of cases and which were classified as severe in 29.2%. Blood count changes, fatigue and liver toxicity occurred most frequently.

CONCLUSIONS

Our analysis provides comprehensive data on the efficacy and tolerability of pegIFNα-2a therapy in patients with CTCL. In terms of response rates and side effect profile, pegIFNα-2a appears to be comparable to IFN-α2a therapy.

摘要

背景

干扰素-α是治疗皮肤 T 细胞淋巴瘤(CTCL)的重要治疗选择。由于批准的重组干扰素-α-2a(IFN-α2a)自 2020 年 1 月以来已不再生产,聚乙二醇化干扰素-α2a(pegIFN-α2a)可用作替代治疗,尽管它未被批准用于治疗 CTCL。本多中心研究的目的是生成关于 pegIFN-α2a 治疗 CTCL 的疗效和耐受性的综合数据。

患者和方法

对来自 12 个德国皮肤中心的 70 例 CTCL 患者进行了多中心回顾性研究。

结果

共有 70 例患者纳入研究,男性占 57.2%,平均年龄为 58.8 ± 14.9 岁。蕈样真菌病占 71.4%,Sézary 综合征占 28.6%。接受 pegIFNα-2a 治疗的总缓解率为 55.2%。在 63.6 ± 33.5 周后,有 50%的病例停止了治疗。停止治疗的最常见原因是不良反应,68.6%的病例发生不良反应,其中 29.2%为严重不良反应。最常发生的血液计数变化、疲劳和肝毒性。

结论

我们的分析提供了关于 pegIFNα-2a 治疗 CTCL 患者的疗效和耐受性的综合数据。就反应率和副作用谱而言,pegIFNα-2a 似乎与 IFN-α2a 治疗相当。

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