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Importance of the cytological samples for the epidermal growth factor receptor gene mutation test for non-small cell lung cancer.

ABSTRACT: Mutations in the epidermal growth factor receptor (EGFR) gene confer it with cancer driver gene functions in non-small cell lung cancer (NSCLC). Epidermal growth factor receptor -tyrosine kinase inhibitors are effective agents against NSCLC with a mutated EGFR gene. Accordingly, many guidelines recommend the use of an EGFR mutation test in NSCLC. However, not all patients are tested in most countries where tissue samples are mainly used for the test. As of 2011, most of the patients with advanced NSCLC are tested in Japan, and the use of cytological samples has significantly contributed to this success. A portion of samples used to determine a definite diagnosis of NSCLC, either tissue samples or cytological samples, is ensured to contain cancer cells, and is then investigated by an EGFR mutation test that is applicable to both tissue samples and cytological samples. Cytological samples now account for one-third of all the samples investigated. EGFR mutation is detected in cytological samples at a similar rate with tissue samples. The criterion ensuring an EGFR mutation test to have satisfactory sensitivity and specificity for use in both tissue and cytological samples is presented. Cytological samples are valuable clinical sources being collected less invasively than tissue samples, and should therefore be extensively used in EGFR mutation testing.

SUBMITTER: Hagiwara K

PROVIDER: S-EPMC7657187 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Importance of the cytological samples for the epidermal growth factor receptor gene mutation test for non-small cell lung cancer.

Hagiwara Koichi K Kobayashi Kunihiko K

Cancer science 20130124 3

Mutations in the epidermal growth factor receptor (EGFR) gene confer it with cancer driver gene functions in non-small cell lung cancer (NSCLC). Epidermal growth factor receptor -tyrosine kinase inhibitors are effective agents against NSCLC with a mutated EGFR gene. Accordingly, many guidelines recommend the use of an EGFR mutation test in NSCLC. However, not all patients are tested in most countries where tissue samples are mainly used for the test. As of 2011, most of the patients with advance ...[more]

PMID: 23240603

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Project description:BackgroundNext-generation sequencing (NGS) has been implemented in clinical oncology to analyze multiple genes and to guide targeted therapy; however, little is known about the performance of the Oncomine Dx Target Test compared with conventional single gene tests for detecting EGFR mutations. The objective of this study was to evaluate the performance of the Oncomine Dx Target Test compared with a PNA-LNA PCR clamp test to detect EGFR mutations.MethodsWe retrospectively reviewed consecutive patients with non-small cell lung cancer (NSCLC) from whom FFPE samples were simultaneously submitted for the Oncomine Dx Target Test, and a PNA-LNA PCR clamp test using the same specimen. We subsequently compared the analysis success rates and detection rates between the two tests.ResultsA total of 116 samples were identified. The success rates and detection rates of EGFR mutations in the total number of samples were 90% and 28%, respectively for the Oncomine Dx Target Test, and 100% and 35% for the PNA-LNA PCR clamp test. The Oncomine Dx Target Test was unable to analyze three samples (2%) due to the samples not passing the nucleic acid concentration threshold, and nine (8%) samples had invalid results. The exon 19 deletion was not detected by the Oncomine Dx Target Test in four cases (4%).ConclusionsThe analytical performance of the Oncomine Dx Target Test analysis for EGFR mutations may not be comparable with conventional single gene tests due to both invalid and false-negative results.Key pointsSignificant findings of the study The success rate of the Oncomine Dx Target Test was significantly lower than the PNA-LNA PCR clamp test. Among the samples successfully analyzed, four exon 19 deletions were not detected by the Oncomine Dx Target Test. What this study adds The analytical performance of the Oncomine Dx Target Test may not be comparable with conventional single gene tests. We should revise the sampling procedures, and review the sample quality assessment methods, to improve the analytical performance.

Dataset Information

Importance of the cytological samples for the epidermal growth factor receptor gene mutation test for non-small cell lung cancer.

Publications

Importance of the cytological samples for the epidermal growth factor receptor gene mutation test for non-small cell lung cancer.

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