胃食管癌的临床试验:来自 ClinicalTrials.gov 的全球介入性试验分析。

IF 3.2 Q2 ONCOLOGY JCO Global Oncology Pub Date : 2024-08-01 DOI:10.1200/GO.24.00169
Ayo S Falade, Oluwatayo Adeoye, Katherine Van Loon, Geoffrey C Buckle
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引用次数: 0

摘要

目的:描述全球胃食管癌(GECs)干预措施临床研究的现状,考察试验特点、试验地点的地理分布以及与试验终止相关的因素:我们查询了 ClinicalTrials.gov,以确定所有已完成或终止的胃食管癌(食管鳞状细胞癌 [ESCC]、食管腺癌 [EAC]、胃食管交界处癌 [GEJ] 和胃腺癌)III 期干预研究。提取了所有报告的试验特征数据。采用皮尔逊卡方检验和费雪精确检验比较已完成试验和已终止试验的差异。多变量逻辑回归评估了终止试验的预测因素:共确定了 179 项试验,其中 90% 为治疗性试验。大多数试验的研究地点位于亚洲(61%)和欧洲(32%),只有极少数试验的研究地点位于非洲(4%)。30%的试验地点位于中低收入国家(LMICs)。大多数研究(70%)关注胃腺癌或 GEJ 腺癌,13% 关注 EAC 和 ESCC,9% 仅关注 ESCC。16%的试验(n = 29)提前终止。在多变量分析中,研究机构数量、招募地点和患者人群成为终止试验的预测因素。从美国招募人员的试验更有可能终止(几率比 [OR],7.22 [95% CI,1.59 至 32.69])。完全在低收入国家/地区进行的试验终止的可能性较低(OR,0.04 [95% CI,0.01-0.59] v 仅在高收入国家/地区进行)。关于 ESCC 的研究更有可能终止(OR,17.74 [95% CI,1.49 至 210.69]):结论:尽管80%的GEC发生在低收入国家,但试验活动却不成比例地发生在高收入国家。尽管EAC/ESCC的致死率很高,但很少有试验关注EAC/ESCC,这凸显了尚未满足的需求。总之,本研究强调了(1)全球高发地区错失了招募患者的机会;(2)迫切需要增加资金、基础设施和对低收入国家和地区 GEC 试验的支持。
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Clinical Trials in Gastroesophageal Cancers: An Analysis of the Global Landscape of Interventional Trials From ClinicalTrials.gov.

Purpose: To describe the global landscape of clinical research into interventions for gastroesophageal cancers (GECs), with examination of trial characteristics, geographic distribution of trial sites, and factors associated with trial termination.

Methods: We queried ClinicalTrials.gov to identify all completed or terminated phase III interventional studies investigating GECs (esophageal squamous cell carcinoma [ESCC], esophageal adenocarcinoma [EAC], gastroesophageal junctional [GEJ], and gastric adenocarcinoma). Data on all reported trial characteristics were extracted. Pearson's chi-square and Fisher's exact tests were used to compare differences in completed and terminated trials. Multivariate logistic regression evaluated predictors of termination.

Results: A total of 179 trials were identified; of these, 90% were therapeutic. Most included sites in Asia (61%) and Europe (32%); few included sites in Africa (4%). Thirty percent included sites in low- and middle-income countries (LMICs). Most (70%) focused on gastric or GEJ adenocarcinoma, 13% on EAC and ESCC, and 9% on ESCC alone. Sixteen percent (n = 29) of trials terminated prematurely. In multivariate analysis, study site number, location of recruitment sites, and patient population emerged as predictors of termination. Trials recruiting from US-based sites were more likely to terminate (odds ratio [OR], 7.22 [95% CI, 1.59 to 32.69]). Trials conducted exclusively in LMICs were less likely to terminate (OR, 0.04 [95% CI, 0.01 to 0.59] v conducted in high-income countries [HICs] alone). Studies on ESCC were more likely to terminate (OR, 17.74 [95% CI, 1.49 to 210.69]).

Conclusion: Although 80% of GECs occur in LMICs, trial activity disproportionately occurs in HICs. Few trials focus on EAC/ESCC despite being highly fatal, highlighting an unmet need. Overall, this study highlights (1) a missed opportunity to recruit patients from high-incidence regions globally; and (2) a pressing need for increasing funding, infrastructure, and support for GEC trials in LMICs.

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来源期刊
JCO Global Oncology
JCO Global Oncology Medicine-Oncology
CiteScore
6.70
自引率
6.70%
发文量
310
审稿时长
7 weeks
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