Ai Tomohiko, Yuri Maiko, Tabe Yoko, Kakimoto Atsushi, Morishita Soji, Tsuchiya Koji, Takamochi Kazuya, Kodama Yuzo, Takahashi Fumiyuki, Shigeki Misawa, Horii Takashi, Suzuki Kenji, Takahashi Kazuhisa, Miida Takashi, Ohsaka Akimichi
Clin Lab. 2017 May 1;63(5):1021-1026. doi: 10.7754/Clin.Lab.2017.161223.
EGFR, a tyrosine-kinase, plays an important role in the progression of lung cancer. Since genetic abnormality of EGFR alters the effects of tyrosine-kinase inhibitors targeting EGFR, molecular analyses of EGFR have recently gained more attention in the treatment of lung cancer. However, several different techniques are available and which method is superior has not been determined. In this study, we compared two recently developed PCR-based techniques, PCR-clamp method and cobas EGFR assay.
Ninety-four surgical samples and 58 biopsy samples from patients suffering from non-small cell lung cancers (NSCLCs) were included in the study. Samples with positive and negative genetic abnormalities, 66 and 28 respectively, were chosen for PCR-Clamp methods. Those same samples were reanalyzed with cobas EGFR assay.
The concordance between PCR-Clamp and cobas EGFR methods was 95.7%. PCR-Clamp failed to detect four mutations that were detected with cobas EGFR assay. These two methods were further tested by analyzing 58 random biopsy samples. The concordance for the biopsy samples was 93.1%, and PCR-Clamp, again, failed to detect three mutations that were detected with cobas EGFR assay.
Our results showed both methods detected most of the known EGFR mutations and the concordance was similar to those previously reported in different ethnicities. However, in our study, PCR-Clamp method failed to detect a total of seven mutations that were detected with cobas EGFR assay. Thus, we concluded that cobas EGFR assay is an easier and more accurate screening assay than PCR-Clamp method in detecting EGFR genetic abnormalities.
表皮生长因子受体（EGFR）是一种酪氨酸激酶，在肺癌进展中起重要作用。由于EGFR的基因异常会改变针对EGFR的酪氨酸激酶抑制剂的效果，因此EGFR的分子分析最近在肺癌治疗中受到了更多关注。然而，有几种不同的技术可供选择，哪种方法更优越尚未确定。在本研究中，我们比较了两种最近开发的基于聚合酶链反应（PCR）的技术，即PCR夹法和cobas EGFR检测法。
本研究纳入了94例非小细胞肺癌（NSCLC）患者的手术样本和58例活检样本。分别选择66例和28例基因异常阳性和阴性的样本用于PCR夹法。同样的样本用cobas EGFR检测法重新分析。
PCR夹法和cobas EGFR检测法之间的一致性为95.7%。PCR夹法未能检测到cobas EGFR检测法检测到的4个突变。通过分析58例随机活检样本对这两种方法进行了进一步测试。活检样本的一致性为93.1%，PCR夹法再次未能检测到cobas EGFR检测法检测到的3个突变。
我们的结果表明，两种方法都检测到了大多数已知的EGFR突变，一致性与之前在不同种族中报道的相似。然而，在我们的研究中，PCR夹法未能检测到cobas EGFR检测法检测到的总共7个突变。因此，我们得出结论，在检测EGFR基因异常方面，cobas EGFR检测法比PCR夹法更容易、更准确。
