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T-VEC 治疗 IIIB-IVM1a 期黑色素瘤可实现高完全缓解率和持久缓解率,并与肿瘤负荷相关:一项临床预测模型研究。

T-VEC for stage IIIB-IVM1a melanoma achieves high rates of complete and durable responses and is associated with tumor load: a clinical prediction model.

机构信息

Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.

Head and Neck Surgery and Oncology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.

出版信息

Cancer Immunol Immunother. 2021 Aug;70(8):2291-2300. doi: 10.1007/s00262-020-02839-7. Epub 2021 Jan 28.

Abstract

BACKGROUND

Talimogene laherparepvec (T-VEC) is a genetically modified herpes simplex type 1 virus and known as an effective oncolytic immunotherapy for injectable cutaneous, subcutaneous and nodal melanoma lesions in stage IIIB-IVM1a patients. This study set out to identify prognostic factors for achieving a complete response that can be used to optimize patient selection for T-VEC monotherapy.

METHODS

Patients with stage IIIB-IVM1a melanoma, treated with T-VEC at the Netherlands Cancer Institute between 2016-12 and 2020-01 with a follow-up time > 6 months, were included. Data were collected on baseline characteristics, responses and adverse events (AEs). Uni- and multivariable analyses were conducted, and a prediction model was developed to identify prognostic factors associated with CR.

RESULTS

A total of 93 patients were included with a median age of 69 years, median follow-up time was 16.6 months. As best response, 58 patients (62%) had a CR, and the overall response rate was 79%. The durable response rate (objective response lasting > 6 months) was 51%. Grade 1-2 AEs occurred in almost every patient. Tumor size, type of metastases, prior treatment with systemic therapy and stage (8Th AJCC) were independent prognostic factors for achieving CR. The prediction model includes the predictors tumor size, type of metastases and number of lesions.

CONCLUSIONS

This study shows that intralesional T-VEC monotherapy is able to achieve high complete and durable responses. The prediction model shows that use of T-VEC in patients with less tumor burden is associated with better outcomes, suggesting use earlier in the course of the disease.

摘要

背景

替莫唑胺拉滨(T-VEC)是一种基因修饰的单纯疱疹病毒 1 型,作为一种有效的溶瘤免疫疗法,用于治疗 IIIB-IVM1a 期可注射皮肤、皮下和淋巴结黑色素瘤病变。本研究旨在确定实现完全缓解的预测因素,以便优化 T-VEC 单药治疗的患者选择。

方法

纳入 2016 年 12 月至 2020 年 1 月期间在荷兰癌症研究所接受 T-VEC 治疗的 IIIB-IVM1a 期黑色素瘤患者,随访时间>6 个月。收集基线特征、反应和不良事件(AE)数据。进行单变量和多变量分析,并建立预测模型,以确定与 CR 相关的预后因素。

结果

共纳入 93 例患者,中位年龄 69 岁,中位随访时间 16.6 个月。最佳反应为 58 例(62%)患者获得 CR,总反应率为 79%。持久反应率(持续时间>6 个月的客观反应)为 51%。几乎所有患者均发生 1-2 级 AE。肿瘤大小、转移类型、系统治疗前治疗和分期(8th AJCC)是实现 CR 的独立预后因素。预测模型包括肿瘤大小、转移类型和病变数量等预测因子。

结论

本研究表明,局部 T-VEC 单药治疗能够实现高完全和持久缓解。预测模型表明,在肿瘤负荷较小的患者中使用 T-VEC 与更好的结果相关,提示在疾病早期使用。

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