唾液腺癌患者的临床试验:全球登记的系统回顾和当前挑战的评估

IF 5.6 2区 医学 Q1 HEMATOLOGY
Pablo Jiménez-Labaig , Luigi Lorini , Cristina Gurizzan , Emma Kinloch , Sarah Burton , Martin D. Forster , Robert Metcalf , Renata Ferrarotto , Paolo Bossi , Ben O´leary , Glenn Hanna , Enriqueta Felip , Irene Braña Garcia , Kevin J. Harrington
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引用次数: 0

摘要

临床试验(CT)对于产生科学证据和改善临床结果至关重要,但在罕见癌症的背景下,它们可能具有挑战性。唾液腺癌(SGC)是一种罕见的异质肿瘤,没有标准治疗批准的全身治疗。我们分析了已完成和正在进行的CT,以评估该领域临床研究活动的现状。方法从临床试验数据库创建到2024年8月6日,在clinicaltrials .gov、WHO-ICTRP、HealthCanadaCT中检索涉及SGC患者的抗肿瘤药理学和介入CT。收集CT特征及状态。结果134项临床试验符合纳入标准。其中,78% %由非工业实体赞助。49% %仅在一个地点进行,61% %在多达五个中心进行。只有25项试验(19 %)是跨国试验,其中15项由行业赞助,与非行业赞助的试验相比,比例显着更高(p <; 0.01)。16 %的ct是伞形或篮形,6 %的随机化,同样主要是行业赞助的(p <; 0.01)。关于SGC特异性试验,32% %对所有SGC患者开放,无论其具体组织学如何。腺样囊性癌、唾液管癌和黏液表皮样癌患者分别获得了92% %、66% %和62% %的试验。88% % CT针对姑息治疗设置,38% %纳入预测性生物标志物。酪氨酸激酶抑制剂是研究最多的治疗方法(26 %),其次是免疫治疗(15 %),化疗和抗体-药物偶联(各12 %)和雄激素阻断(8 %)等。结论SGC患者的临床研究主要依赖于非工业组织,其中大多数仅限于在一个国家的一到五个地点进行试验。研究者之间需要进一步合作,并重新考虑纳入标准和试验设计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical trials for patients with salivary gland cancers: A systematic review of worldwide registers and an evaluation of current challenges

Background

Clinical trials (CT) are crucial for generating scientific evidence and improving clinical outcomes, but they can be challenging in the context of rare cancers. Salivary gland cancers (SGC) are rare and heterogeneous tumors, without standard-of-care approved systemic therapies. We analyzed completed and ongoing CTs to assess the current state of clinical research activity in the field.

Methods

ClinicalTrials.gov, WHO-ICTRP, HealthCanadaCT were searched for antineoplastic pharmacological and interventional CT involving patients with SGC from the trials database creation until August 6th, 2024. CT characteristics and status were collected.

Results

134 clinical trials met inclusion criteria. Of these, 78 % were sponsored by non-industry entities. 49 % were conducted at only one site, and 61 % at up to five centers. Only 25 trials (19 %) were multinational, being 15 industry-sponsored, a significantly higher proportion compared to non-industry-sponsored trials(p < 0.01). 16 % CTs were umbrella or basket, and 6 % were randomized, again predominantly industry-sponsored(p < 0.01). Regarding SGC-specific trials, 32 % were open to all patients with SGC, regardless of specific histology. Patients with adenoid cystic, salivary duct, and mucoepidermoid carcinoma had access to 92 %, 66 % and 62 % of trials, respectively. 88 % CT targeted palliative setting, and 38 % incorporated predictive biomarkers. Tyrosine kinase inhibitors were the most studied therapy(26 %), followed by immunotherapy(15 %), chemotherapy and antibody-drug conjugate(12 % each) and androgen-blockade(8 %), among others.

Conclusion

Clinical research for patients with SGC relies mainly in non-industry organisations, most of them limited to run trials in one to five sites, in a single country. Further collaboration between investigators is needed, as well as reconsidering inclusion criteria and trial designs.
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来源期刊
CiteScore
11.00
自引率
3.20%
发文量
213
审稿时长
55 days
期刊介绍: Critical Reviews in Oncology/Hematology publishes scholarly, critical reviews in all fields of oncology and hematology written by experts from around the world. Critical Reviews in Oncology/Hematology is the Official Journal of the European School of Oncology (ESO) and the International Society of Liquid Biopsy.
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