在奥地利、瑞士和德国的中心，对黑色素瘤患者使用替莫唑胺（T-VEC）的实际应用。

Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany.

机构信息

Department of Dermatology, Medical University of Vienna, Vienna, Austria

Department of Dermatology, University Hospital St. Poelten, Karl Landsteiner University of Health Sciences, St Poelten, Austria.

出版信息

J Immunother Cancer. 2021 Feb;9(2). doi: 10.1136/jitc-2020-001701.

BACKGROUND

Talimogene laherparepvec (T-VEC) is a licensed therapy for use in melanoma patients of stage IIIB-IVM1a with injectable, unresectable metastatic lesions in Europe. Approval was based on the Oncovex Pivotal Trial in Melanoma study, which also included patients with distant metastases and demonstrated an overall response rate (ORR) of 40.5% and a complete response (CR) rate of 16.6%.

OBJECTIVES

The aim of this study was to assess the outcome of melanoma patients treated with T-VEC in a real-life clinical setting.

METHODS

Based on data from 10 melanoma centers in Austria, Switzerland and southern Germany, we conducted a retrospective chart review, which included 88 patients (44 male, 44 female) with a median age of 72 years (range 36-95 years) treated with T-VEC during the period from May 2016 to January 2020.

RESULTS

88 patients fulfilled the inclusion criteria for analysis. The ORR was 63.7%. 38 patients (43.2%) showed a CR, 18 (20.5%) had a partial response, 8 (9.1%) had stable disease and 24 (27.3%) patients had a progressive disease. The median treatment period was 19 weeks (range: 1-65), an average of 11 doses (range: 1-36) were applied. 39 (45.3%) patients developed adverse events, mostly mild, grade I (64.1%).

CONCLUSION

This real-life cohort treatment with T-VEC showed a high ORR and a large number of durable CRs.

背景

替莫唑胺拉滨（T-VEC）是一种在欧洲被批准用于治疗 IIIB-IVM1a 期有可注射性、不可切除的转移性病变的黑色素瘤患者的治疗药物。批准基于 Oncovex 黑色素瘤关键试验，该试验也纳入了有远处转移的患者，显示出 40.5%的总体缓解率（ORR）和 16.6%的完全缓解率（CR）。

目的

本研究旨在评估 T-VEC 在真实临床环境中治疗黑色素瘤患者的结果。

方法

根据来自奥地利、瑞士和德国南部 10 个黑色素瘤中心的数据，我们进行了回顾性病历审查，共纳入 88 名（44 名男性，44 名女性）中位年龄为 72 岁（范围 36-95 岁）的患者，他们在 2016 年 5 月至 2020 年 1 月期间接受了 T-VEC 治疗。

结果

88 名患者符合分析纳入标准。ORR 为 63.7%。38 名（43.2%）患者出现 CR，18 名（20.5%）患者有部分缓解，8 名（9.1%）患者病情稳定，24 名（27.3%）患者疾病进展。中位治疗期为 19 周（范围：1-65），平均应用 11 个剂量（范围：1-36）。39 名（45.3%）患者出现不良反应，大多为轻度、1 级（64.1%）。