研究动态
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非转移性三阴性乳腺癌的溶瘤性T-VEC病毒治疗加新辅助化疗:一个二期试验。

Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial.

发表日期:2023 Feb
作者: Hatem Soliman, Deanna Hogue, Hyo Han, Blaise Mooney, Ricardo Costa, Marie C Lee, Bethany Niell, Angela Williams, Alec Chau, Shannon Falcon, Aixa Soyano, Avan Armaghani, Nazanin Khakpour, Robert J Weinfurtner, Susan Hoover, John Kiluk, Christine Laronga, Marilin Rosa, Hung Khong, Brian Czerniecki
来源: NATURE MEDICINE

摘要:

Talimogene laherparepvec(T-VEC)是一种致癌病毒,被假设能够增强三阴性乳腺癌(TNBC)对新辅助化疗(NAC)的反应。本文描述了T-VEC联合NAC(ClinicalTrials.gov ID:NCT02779855)的二期试验。阶段2-3 TNBC患者接受了5次肿瘤内T-VEC注射,与紫杉醇、多柔比星和环磷酰胺一起使用,并进行手术评估剩余癌症负担指数(RCB)。主要终点是RCB0率。次要终点是RCB0-1率、复发率、毒性和免疫相关。共评估了37名患者。常见的T-VEC毒性包括发热、寒战、头痛、疲劳和注射部位疼痛。NAC毒性如预期。发生了4起血栓栓塞事件。主要终点达到了估计的RCB0率=45.9%和RCB0-1描述性率=65%。2年无病生存率为89%,RCB0-1患者没有复发。治疗期间的免疫激活与反应相关。 TNBC中的T-VEC加NAC可能增加RCB0-1率。这些结果支持继续研究T-VEC加NAC治疗TNBC。©2023年。作者(s)在Springer Nature America,Inc.的专属许可下发表。
Talimogene laherparepvec (T-VEC) is an oncolytic virus hypothesized to enhance triple-negative breast cancer (TNBC) responses to neoadjuvant chemotherapy (NAC). This article describes the phase 2 trial of T-VEC plus NAC (ClinicalTrials.gov ID: NCT02779855 ). Patients with stage 2-3 TNBC received five intratumoral T-VEC injections with paclitaxel followed by doxorubicin and cyclophosphamide and surgery to assess residual cancer burden index (RCB). The primary end point was RCB0 rate. Secondary end points were RCB0-1 rate, recurrence rate, toxicity and immune correlates. Thirty-seven patients were evaluated. Common T-VEC toxicities were fevers, chills, headache, fatigue and injection site pain. NAC toxicities were as expected. Four thromboembolic events occurred. The primary end point was met with an estimated RCB0 rate = 45.9% and RCB0-1 descriptive rate = 65%. The 2-year disease-free rate is equal to 89% with no recurrences in RCB0-1 patients. Immune activation during treatment correlated with response. T-VEC plus NAC in TNBC may increase RCB0-1 rates. These results support continued investigation of T-VEC plus NAC for TNBC.© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.