Ye Peng, Cai Peiling, Xie Jing, Zhang Jie
Department of Anatomy and Histology, College of Medicine, Chengdu University.
Department of Pathology and Clinical Laboratory, Sichuan Provincial Fourth People's Hospital.
Medicine (Baltimore). 2020 Jul 10;99(28):e21171. doi: 10.1097/MD.0000000000021171.
Test on the KRAS somatic mutation status is necessary before cetuximab and panitumumab treatments are given to colorectal cancer patients. Metastatic colorectal cancer patients sometimes lack tumor tissue samples, and the testing of KRAS mutation in plasma samples requires highly sensitive methods.
The aim of this study was to evaluate the accuracy of digital PCR in detecting KRAS mutation in plasma samples of colorectal cancer patients.
Literature research was conducted in Pubmed, Embase, and Cochrane Library.
STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Database searching found 188 relevant studies. After removing duplicates, eligible studies were selected from 151 publications using the following exclusion criteria: STUDY APPRAISAL AND SYNTHESIS METHODS:: Data were extracted from the eligible studies by 2 independent researchers. Pooled accuracy parameters were calculated from those extracted data using Meta-DiSc and STATA software.
Twelve eligible studies were selected for the systematic review and meta-analysis. After calculation, the pooled sensitivity and specificity were 0.83 (95% CI: 0.79-0.86) and 0.91 (95%CI: 0.88-0.93), respectively. Pooled positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were 7.30 (95%CI: 4.78-11.17), 0.22 (95%CI: 0.15-0.32), and 41.00 (95%CI: 21.07-79.78), respectively. Area under curve of the summarized ROC curve was 0.9322.
Although no significant bias was identified, number of included studies was still quite small, especially in subgroup analysis.
Digital PCR showed high accuracy and could be a reliable detection method for KRAS mutation in plasma samples. Large-cohort prospective study is required to further confirm the usefulness of digital PCR in KRAS mutation detection.
在对结直肠癌患者给予西妥昔单抗和帕尼单抗治疗之前，检测KRAS体细胞突变状态是必要的。转移性结直肠癌患者有时缺乏肿瘤组织样本，而血浆样本中KRAS突变的检测需要高灵敏度的方法。
本研究旨在评估数字PCR检测结直肠癌患者血浆样本中KRAS突变的准确性。
在PubMed、Embase和Cochrane图书馆进行文献研究。
研究入选标准、参与者和干预措施：数据库检索发现188项相关研究。去除重复项后，使用以下排除标准从151篇出版物中选择符合条件的研究：研究评估和综合方法：数据由2名独立研究人员从符合条件的研究中提取。使用Meta-DiSc和STATA软件从提取的数据中计算合并准确性参数。
选择12项符合条件的研究进行系统评价和荟萃分析。计算后，合并灵敏度和特异性分别为0.83（95%CI：0.79 - 0.86）和0.91（95%CI：0.88 - 0.93）。合并阳性似然比、阴性似然比和诊断比值比分别为7.30（95%CI：4.78 - 11.17）、0.22（95%CI：0.15 - 0.32）和41.00（95%CI：21.07 - 79.78）。汇总ROC曲线下面积为0.9322。
虽然未发现显著偏倚，但纳入研究的数量仍然相当少，尤其是在亚组分析中。
数字PCR显示出高准确性，可能是血浆样本中KRAS突变的可靠检测方法。需要进行大样本队列前瞻性研究以进一步证实数字PCR在KRAS突变检测中的实用性。
