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Radiotherapy with cetuximab or durvalumab for locoregionally advanced head and neck cancer in patients with a contraindication to cisplatin (NRG-HN004): an open-label, multicentre, parallel-group, randomised, phase 2/3 trial.西妥昔单抗或度伐利尤单抗用于顺铂禁忌的局部晚期头颈癌患者的放疗(NRG-HN004):一项开放标签、多中心、平行组、随机、2/3期试验。
Lancet Oncol. 2024 Dec;25(12):1576-1588. doi: 10.1016/S1470-2045(24)00507-2. Epub 2024 Nov 14.
2
Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design.Xevinapant 联合放疗用于可切除、高危、顺铂禁忌的局部晚期头颈部鳞状细胞癌:III 期 XRay Vision 研究设计。
Future Oncol. 2024 Apr;20(12):739-748. doi: 10.2217/fon-2023-0774. Epub 2024 Jan 10.
3
Managing cisplatin-ineligible patients with resected, high-risk, locally advanced squamous cell carcinoma of the head and neck: Is there a standard of care?管理经顺铂治疗无效的、经手术切除的、高危、局部晚期头颈部鳞状细胞癌患者:是否存在标准治疗方法?
Cancer Treat Rev. 2023 Sep;119:102585. doi: 10.1016/j.ctrv.2023.102585. Epub 2023 Jun 15.
4
Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation.头颈部癌症患者中多西他赛作为放射增敏剂的 III 期随机试验结果,不适合顺铂为基础的放化疗。
J Clin Oncol. 2023 May 1;41(13):2350-2361. doi: 10.1200/JCO.22.00980. Epub 2023 Jan 27.
5
Pembrolizumab versus cetuximab concurrent with radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck unfit for cisplatin (GORTEC 2015-01 PembroRad): a multicenter, randomized, phase II trial.帕博利珠单抗与西妥昔单抗联合放疗用于不适合顺铂治疗的局部晚期头颈部鳞状细胞癌患者(GORTEC 2015 - 01 PembroRad):一项多中心、随机、II期试验
Ann Oncol. 2023 Jan;34(1):101-110. doi: 10.1016/j.annonc.2022.10.006. Epub 2022 Oct 28.
6
Cetuximab-Based vs Carboplatin-Based Chemoradiotherapy for Patients With Head and Neck Cancer.西妥昔单抗联合放化疗与卡铂联合放化疗治疗头颈部癌症患者的比较。
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Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.复发和/或转移性头颈部鳞状细胞癌中同步西妥昔单抗和纳武利尤单抗的多机构 II 期临床试验结果。
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顺铂不耐受的头颈部鳞状细胞癌患者同步免疫治疗与放疗:一项系统评价与荟萃分析

Concurrent immunotherapy and radiation in cisplatin-ineligible patients with HNSCC: a systematic review & meta-analysis.

作者信息

Chan Sze Wah Samuel, Al Maqrashi Zainab Ali Amer, Young Jack, Kim Do-Hoon, Pond Gregory, Meyers Brandon M, Kartolo Adi

机构信息

Department of Oncology, McMaster University, Hamilton, ON, Canada.

Escarpment Cancer Research Institute, Juravinski Cancer Centre, Hamilton, ON, Canada.

出版信息

Immunotherapy. 2024;16(20-22):1227-1233. doi: 10.1080/1750743X.2024.2436346. Epub 2024 Dec 6.

DOI:10.1080/1750743X.2024.2436346
PMID:39641447
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11758945/
Abstract

BACKGROUND

Head and squamous cell carcinoma (HNSCC) in the locally advanced setting is challenging to treat and remains an area of significant morbidity and mortality. For patients who are cisplatin-ineligible and considered unresectable, there is no clear standard of care including the choice of radiosensitizer.

METHODS

OVID Medline, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched. Randomized clinical trials (RCTs) of cisplatin-ineligible unresectable HNSCC patients who were randomized to an immune checkpoint inhibitor concurrent with radiation compared to a control arm were included. Data was pooled and assessed using a random-effects model for the meta-analysis.

RESULTS

Three eligible RCTs were identified and analyzed which comprised 594 patients whose median age ranged from 65-72 years. There was no difference in overall survival (pooled HR 1.02, 95% CI 0.76-1.37,  = 0.88) or PFS (pooled HR 0.92, 95% CI 0.68-1.23,  = 0.56). Grade greater than or equal to 3 adverse events were favored to be less in the immunotherapy arm.

CONCLUSIONS AND RELEVANCE

Immune-checkpoint inhibitors are not superior to cetuximab when used with definitive radiation in HNSCC. Further study is warranted, given its potential signal for non-inferior survival with less toxicity profile trends.

摘要

背景

局部晚期头颈部鳞状细胞癌(HNSCC)的治疗具有挑战性,仍然是发病率和死亡率较高的领域。对于不符合顺铂治疗条件且被认为无法切除的患者,尚无明确的治疗标准,包括放射增敏剂的选择。

方法

系统检索了OVID Medline、EMBASE和Cochrane对照试验中央注册库。纳入了不符合顺铂治疗条件的不可切除HNSCC患者的随机临床试验(RCT),这些患者被随机分配接受免疫检查点抑制剂联合放疗,与对照组进行比较。采用随机效应模型对数据进行汇总和评估,以进行荟萃分析。

结果

确定并分析了三项符合条件的RCT,共纳入594例患者,中位年龄在65至72岁之间。总生存期(合并风险比1.02,95%置信区间0.76 - 1.37,P = 0.88)或无进展生存期(合并风险比0.92,95%置信区间0.68 - 1.23,P = 0.56)无差异。免疫治疗组大于或等于3级不良事件的发生率较低。

结论及相关性

在HNSCC的根治性放疗中,免疫检查点抑制剂与西妥昔单抗相比并无优势。鉴于其在生存方面有非劣效性且毒性较低的潜在趋势,有必要进一步研究。