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人表皮生长因子受体 2(HER2)阳性复发性或转移性唾液腺癌中 HER2 靶向治疗的临床应用及治疗持续时间。

The Clinical Utilisation and Duration of Treatment with HER2-Directed Therapies in HER2-Positive Recurrent or Metastatic Salivary Gland Cancers.

机构信息

The Christie NHS Foundation Trust, Wilmslow Road Manchester, Manchester M20 4BX, UK.

The Royal Marsden NHS Foundation Trust, Fulham Road, London SW3 6JJ, UK.

出版信息

Curr Oncol. 2024 Sep 21;31(9):5652-5661. doi: 10.3390/curroncol31090419.

Abstract

Salivary gland cancers (SGC) are rare tumours with limited availability of systemic therapies. Some SGC subtypes overexpress HER2, and this represents a potential therapeutic target, but the evidence base is limited. This study sought to analyse real-world data on the efficacy of HER2-directed therapies in SGC. This is a retrospective observational study using anonymised data from commercial compassionate-use access registrations and a privately funded pharmacy prescribing register. Treatment duration was defined as the time from drug initiation to treatment discontinuation. Kaplan-Meier analysis of treatment duration was performed using R for Windows (v4.3.2). A case report is also provided of an exceptional responder. Eighteen patients were identified who received HER2-directed therapies for HER2-positive recurrent/metastatic SGC, and complete data on treatment duration was available for 15/18. Histology was salivary duct carcinoma in 13/18 patients, adenocarcinoma NOS in 4/18, and carcinoma ex pleomorphic adenoma in 1/18. The median treatment duration was 8.3 months (95% CI: 6.41-not reached), and the range was 1.0-47.0 months. Choice of HER2-directed therapy varied, with ado-trastuzumab emtasine being the most common (9/18). At the time of analysis, HER2-directed therapy was ongoing for 9/15, discontinued due to disease progression for 4/15, discontinued due to toxicity for 1/15, and 1/15 was discontinued for an unspecified reason. An exceptional responder experienced a complete response with a treatment duration of 47.0 months. These real-world data are comparable to the median PFS observed with HER2-directed therapies in phase II trials and support the use of HER2-directed therapies in this group.

摘要

唾液腺癌(SGC)是一种罕见的肿瘤,系统治疗方法有限。某些 SGC 亚型过表达 HER2,这代表了一个潜在的治疗靶点,但证据基础有限。本研究旨在分析 HER2 靶向治疗在 SGC 中的真实世界数据。这是一项回顾性观察性研究,使用来自商业同情使用准入注册和私人资助药房处方登记的匿名数据。治疗持续时间定义为从药物开始到治疗停止的时间。使用 R for Windows(v4.3.2)对治疗持续时间进行 Kaplan-Meier 分析。还提供了一个例外响应者的病例报告。确定了 18 名接受 HER2 靶向治疗 HER2 阳性复发性/转移性 SGC 的患者,其中 15/18 例可获得完整的治疗持续时间数据。18 例患者中,组织学为涎管癌 13/18 例,非特定腺癌 4/18 例,癌前多形性腺瘤 1/18 例。中位治疗持续时间为 8.3 个月(95%CI:6.41-未达到),范围为 1.0-47.0 个月。HER2 靶向治疗的选择多种多样,阿多曲妥珠单抗emtansine 最为常见(9/18)。在分析时,9/15 例正在进行 HER2 靶向治疗,4/15 例因疾病进展而停止,1/15 例因毒性而停止,1/15 例因不明原因停止。一位例外响应者的治疗持续时间为 47.0 个月,完全缓解。这些真实世界的数据与 II 期试验中观察到的 HER2 靶向治疗的中位 PFS 相当,支持在该组中使用 HER2 靶向治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e5/11431065/d7b8af6537fe/curroncol-31-00419-g001.jpg

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