鼻咽癌临床试验的全面回顾和特征描述。

Q2 Medicine World Journal of OtorhinolaryngologyHead and Neck Surgery Pub Date : 2022-09-30 eCollection Date: 2023-06-01 DOI:10.1002/wjo2.80
Katherine Xu, Emma De Ravin, Neeraj Suresh, Robert M Brody, Karthik Rajasekaran
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摘要

目的:虽然原发性鼻咽癌(NPC)的标准治疗方法是放化疗,但对于复发或转移性疾病的治疗仍未达成共识。我们对近期的鼻咽癌临床试验进行了特征分析,以评估鼻咽癌治疗的趋势,并确定未来有希望的研究领域:研究设计:回顾性数据库研究:研究设计:回顾性数据库研究:方法:回顾性审查 1999 年 11 月至 2021 年 6 月期间的所有鼻咽癌试验。对每项研究提取以下变量:研究特征、干预措施、结果测量和纳入标准。通过 PubMed 和 Google scholar 进行二次检索,确定试验的发表状态:结果:共发现 448 项临床试验:72项(16%)观察性试验和376项(84%)干预性试验,其中I期试验30项(8%),II期试验183项(49%),III期试验86项(23%),IV期试验5项(1%)。54%的试验只包括原发性鼻咽癌,111项(25%)专门研究复发性癌症。最常见的干预措施是顺铂(64 例)和强度调节放射治疗(54 例);有 38 项试验涉及 PD-1 单克隆抗体。34项研究对生活质量进行了检测,包括口腔干燥症和粘膜炎。在已完成的研究中,53.2%的研究发表了手稿。患者应征不足是研究过早终止的最常见原因:结论:近年来,新型免疫疗法越来越多地被纳入鼻咽癌研究,然而,尽管化疗和放疗有很多副作用,但由于其临床疗效显著,仍被广泛使用。未来有必要进行试验,以确定最佳治疗方案,降低复发率和副作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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A comprehensive review and characterization of nasopharyngeal carcinoma clinical trials.

Objective: Although standard of care for primary nasopharyngeal carcinoma (NPC) is chemoradiotherapy, there remains no consensus on management of recurrent or metastatic disease. We characterized recent clinical trials on NPC to assess trends in NPC treatment and establish promising areas for future research.

Study design: Retrospective database study.

Setting: ClinicalTrials.gov database.

Methods: Retrospective review of all NPC trials from November 1999 to June 2021. For each study, the following variables were extracted: study characteristics, intervention, outcome measures, and inclusion criteria. Secondary searches via PubMed and Google scholar determined trial publication status.

Results: A total of 448 clinical trials were identified: 72 (16%) observational and 376 (84%) interventional, of which there were 30 (8%) Phase I, 183 (49%) Phase II, 86 Phase III (23%), and 5 (1%) Phase IV trials. Fifty-four percent of trials included only primary NPC while 111 (25%) exclusively studied recurrent cancers. The most common interventions were cisplatin (n = 64) and intensity modulated radiation therapy (n = 54); there were 38 trials involving PD-1 monoclonal antibodies. Thirty-four studies examined quality of life measures, including xerostomia and mucositis. Of the completed studies, 53.2% have published manuscripts. Poor patient accrual was the most common reason for premature study termination.

Conclusions: Novel immunotherapies have been increasingly incorporated into NPC studies in recent years, however, chemotherapy and radiation, despite their numerous side effects, are still widely used due to their clinical effectiveness. Future trials are warranted to determine the optimal therapeutic regimens to decrease relapse rates and side effects.

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CiteScore
4.10
自引率
0.00%
发文量
283
审稿时长
13 weeks
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