Zhang Meng, Chen Xiaowei, Zhou Qingxin, Guo Nana, Cao Baoshan, Zeng Hongmei, Chen Wanqing, Sun Feng
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China.
J Natl Cancer Cent. 2024 Dec 27;5(2):156-166. doi: 10.1016/j.jncc.2024.10.002. eCollection 2025 Apr.
Circulating tumor DNA (ctDNA) has shown potential as a prognostic biomarker in patients with solid tumors. This study aimed to systematically summarize the global application of ctDNA in the prognostic management of solid tumor patients and to evaluate the quality of the current studies.
PubMed, Web of Science, Embase, Cochrane Library, Scopus, and clinical trials.gov databases were searched to collect cohort studies on ctDNA in the prognosis of solid tumor patients from January 2016 to May 2022. The language was limited to English. Information including general information, participants and cancer characteristics, ctDNA and outcome information were extracted. The quality of the studies was assessed using the Newcastle-Ottawa Scale checklist.
A total of 214 studies were included in the final analysis, encompassing 21,076 patients. The number of studies has increased annually from 2016 to 2022. The most common types of solid tumors studied were colorectal cancer (27.10 %), lung cancer (20.09 %), pancreatic cancer (16.82 %), and breast cancer (14.02 %). The top three journals by number of publications had an impact factor in 2023 greater than 10. Of the studies, the median sample size was 69 (interquartile range: 41-111), 69.81 % had a sample size <100, 68.92 % had a median/mean age ≥60 years, and 74.05 % were from developed countries. Multi-center studies accounted for 40.36 %. Additionally, 29.82 % of the studies had a bias risk score ≤6. Only 16.67 % of studies on liver cancer had a bias risk score >6. The primary criteria not met by the studies included "Adequacy of follow-up of cohorts" (33.33 %), "Assessment of outcome" (32.16 %) and "Representativeness of the exposed cohort" (27.49 %).
The prognostic value of ctDNA in patients with solid tumors is gaining increasing attention, leading to a steady rise in the number of studies. However, many studies still suffer from small sample sizes and a lack of representativeness. Furthermore, details regarding ctDNA detection methods and results reporting are often insufficiently described. There is an urgent need to improve the quality of such research.
循环肿瘤DNA（ctDNA）已显示出作为实体瘤患者预后生物标志物的潜力。本研究旨在系统总结ctDNA在实体瘤患者预后管理中的全球应用情况，并评估当前研究的质量。
检索PubMed、Web of Science、Embase、Cochrane图书馆、Scopus和临床试验.gov数据库，以收集2016年1月至2022年5月期间关于ctDNA在实体瘤患者预后方面的队列研究。语言限制为英语。提取包括一般信息、参与者和癌症特征、ctDNA及结局信息等内容。使用纽卡斯尔-渥太华量表清单评估研究质量。
最终分析共纳入214项研究，涉及21076名患者。从2016年到2022年，研究数量逐年增加。研究最多的实体瘤类型为结直肠癌（27.10%）、肺癌（20.09%）、胰腺癌（16.82%）和乳腺癌（14.02%）。发表数量排名前三的期刊在2023年的影响因子大于10。在这些研究中，样本量中位数为69（四分位间距：41 - 111），69.81%的样本量<100，68.92%的中位数/平均年龄≥60岁，74.05%来自发达国家。多中心研究占40.36%。此外，29.82%的研究偏倚风险评分≤6。肝癌研究中只有16.67%的偏倚风险评分>6。这些研究未满足的主要标准包括“队列随访的充分性”（33.33%）、“结局评估”（32.16%）和“暴露队列的代表性”（27.49%）。
ctDNA在实体瘤患者中的预后价值越来越受到关注，导致研究数量稳步上升。然而，许多研究仍存在样本量小和缺乏代表性的问题。此外，关于ctDNA检测方法和结果报告的细节往往描述不足。迫切需要提高此类研究的质量。
