QBiotics Group Limited, Yungaburra, Queensland, Australia.
Iowa State University, College of Veterinary Medicine, Ames, Iowa, USA.
J Vet Intern Med. 2021 Jan;35(1):451-455. doi: 10.1111/jvim.16018. Epub 2020 Dec 22.
Tigilanol tiglate (TT) is a novel small molecule approved by the European Medicines Agency for intratumoral treatment of mast cell tumors (MCTs) in dogs. In a randomized controlled clinical efficacy and safety study in the United States, 85 of 116 dogs that received a single TT injection achieved complete response (CR) of the treated MCT by day 28.
To evaluate the durability of the TT treatment response achieved at day 28 in the U.S. study by assessing MCT recurrence at the treatment site 6 and 12 months after TT administration.
Eighty-five dogs previously treated with TT.
Dogs that achieved CR at day 28 were assessed retrospectively for the presence or absence of MCT at the treatment site using records from clinical visits and telephone interviews with owners. Dogs unavailable at an assessment time were considered lost-to-follow-up and data for their last assessment used in the final analysis.
By 12 months after TT treatment, 64 dogs remained evaluable, with 21 unavailable. Of evaluable patients, 57 (89%) remained tumor free at the treatment site and 7 (11%) had developed recurrence. All recurrences occurred within the first 6 months, predominantly (5/7, 71%) within the first 12 weeks.
Tigilanol tiglate provided a durable long-term local response for the treatment of MCT in dogs.
替吉利隆(TT)是一种新型小分子药物,已获欧洲药品管理局批准,用于犬类肿瘤内治疗肥大细胞瘤(MCT)。在美国一项随机对照临床疗效和安全性研究中,接受 TT 单次注射的 116 只犬中有 85 只在第 28 天达到治疗的 MCT 完全缓解(CR)。
通过评估 TT 给药后 6 个月和 12 个月时治疗部位 MCT 复发情况,评估美国研究中第 28 天 TT 治疗应答的持久性。
85 只曾接受 TT 治疗的犬。
对第 28 天达到 CR 的犬,通过查阅临床就诊记录和对犬主人进行电话访谈,回顾性评估治疗部位是否存在 MCT。在评估时间无法联系到的犬被认为是失访,将其最后一次评估的数据用于最终分析。
TT 治疗后 12 个月时,64 只犬仍可评估,21 只犬无法评估。在可评估的患者中,57 只(89%)治疗部位无肿瘤,7 只(11%)发生复发。所有复发均发生在 6 个月内,主要(5/7,71%)在第 12 周内。
替吉利隆为犬类 MCT 的治疗提供了持久的长期局部应答。