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II期试验（NeoBCC试验）

原文发布日期：2025-01-16

英文摘要：

摘要翻译：

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文章：

II期试验（NeoBCC试验）

a phase II trial (NeoBCC trial)

原文发布日期：2025-01-16

英文摘要：

We present a single-arm, phase II, neoadjuvant trial with the oncolytic virus talimogene laherparepvec (T-VEC) in 18 patients with difficult-to-resect cutaneous basal cell carcinomas. The primary end point, defined as the proportion of patients, who after six cycles of T-VEC (13 weeks), become resectable without the need for plastic reconstructive surgery, was already achieved after stage I (9 of 18 patients; 50.0%); thus the study was discontinued for early success. The objective response rate was 55.6% and the complete pathological response rate was 33.3%. Secondary end points included safety, relapse-free survival and overall survival, time to occurrence of new basal cell carcinomas and biological read outs. Only mild adverse events occurred. The 6-month relapse-free survival and overall survival rates were 100%. In two patients a new basal cell carcinoma was diagnosed. T-VEC led to a significant increase in cytotoxic T cells (P = 0.0092), B cells (P = 0.0004) and myeloid cells (P = 0.0042) and a decrease in regulatory T cells (P = 0.0290) within the tumor microenvironment. Together, neoadjuvant T-VEC represents a viable treatment option for patients with difficult-to-resect basal cell carcinomas (EudraCT no. 2018-002165-19).

摘要翻译：

我们介绍了一个单臂、II期、辅助治疗研究，使用了Talimogene laherparepvec（T-VEC）作为单剂，在18例难切除性皮肤基底细胞癌患者中进行。主要终点是经过6个周期（共13周）的辅助治疗后，是否能够完全切除肿瘤而无需进行 reconstructive 手术，这一主要终点在I期阶段就已经达到（9/18名受试者，50.0%）。因此，研究提前终止了。研究的目标反应率为55.6%，完全病理学应答率为33.3%。次要终点包括安全性、无进展生存时间和总生存率，以及新发基底细胞癌的发生时间以及生物指标等。在研究期间，仅出现了轻度的不良事件。6个月后，100%的受试者实现了无进展生存，而100%的受试者也实现了总生存。在此研究过程中，有2例患者诊断出新发基底细胞癌。T-VEC导致了显著增加的 cytotoxic T 细胞（P = 0.0092）、B 细胞（P = 0.0004）和 myeloid 细胞（P = 0.0042），同时在肿瘤微环境中的 Regulatory T 细胞显著减少（P = 0.0290）。总体而言，单剂 T-VEC 作为辅助治疗代表了一个可行的治疗方法方案，适用于难切除性基底细胞癌患者（EudraCT 号码：2018-002165-19）。