open access

Vol 7, No 3 (2011)
Research paper
Published online: 2011-08-23
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Validation of selected medical centers involved in molecular diagnostics of cancer in the field of EGFR1 mutations determination

Andrzej Tysarowski, Dariusz Kowalski, Oksana Kowalczuk, Lech Chyczewski, Ewelina Antoszewska, Janusz Limon, Artur Kowalik, Stanisław Góźdź, Paweł Krawczyk, Łukasz Łaczmański, Anna Szumera-Ciećkiewicz, Włodzimierz P. Olszewski, Maciej Krzakowski, Janusz A. Siedlecki
Onkol. Prak. Klin 2011;7(3):138-145.

open access

Vol 7, No 3 (2011)
ORIGINAL ARTICLES
Published online: 2011-08-23

Abstract

Lung cancer is one of the most common cancers in Poland and abroad. According to statistics, it causes the death of 1.3 million people per year worldwide. In a nonsmall cell lung cancer (NSCLC), some patients have somatic mutations in the gene for epidermal growth factor receptor (EGFR), resulting in a constant activity of this receptor (10–15% patients of North American and Western European origin, and 30–35% of patients from Japan and Eastern Asia). The occurrence of such mutations is closely associated with efficacy of tyrosine kinase inhibitors (TKI). Thus, determination of EGFR status is crucial in selecting the most appropriate treatment of patients with NSCLC.
The aim of this paper is to show whether the laboratories involved in molecular diagnostics for cancer have the potential to effectively determinate the mutation status (in exons 19 and 21) of the EGFR1 gene. An additional objective is to develop appropriate standards for mutation testing in non-small cell lung cancer. As the result of valiadtion process conducted in the study, the following recommendations for diagnostic laboratories were approved: at least 50% of cancer cells should be present in a tissue for DNA isolation; 2. The method of DNA isolation should be standardized, the most appropriate is usage of DNA isolation kits; 3. In case of equivocal results two independent molecular methods should be employed, one of them should be direct sequencing; 4. It is recommended to extend the panel of analyzed exons to 18, 19, 20 and 21; 5 The turnaround time (TAT) should not take more than 10 working days
Onkol. Prak. Klin. 2011; 7, 3: 138–145

Abstract

Lung cancer is one of the most common cancers in Poland and abroad. According to statistics, it causes the death of 1.3 million people per year worldwide. In a nonsmall cell lung cancer (NSCLC), some patients have somatic mutations in the gene for epidermal growth factor receptor (EGFR), resulting in a constant activity of this receptor (10–15% patients of North American and Western European origin, and 30–35% of patients from Japan and Eastern Asia). The occurrence of such mutations is closely associated with efficacy of tyrosine kinase inhibitors (TKI). Thus, determination of EGFR status is crucial in selecting the most appropriate treatment of patients with NSCLC.
The aim of this paper is to show whether the laboratories involved in molecular diagnostics for cancer have the potential to effectively determinate the mutation status (in exons 19 and 21) of the EGFR1 gene. An additional objective is to develop appropriate standards for mutation testing in non-small cell lung cancer. As the result of valiadtion process conducted in the study, the following recommendations for diagnostic laboratories were approved: at least 50% of cancer cells should be present in a tissue for DNA isolation; 2. The method of DNA isolation should be standardized, the most appropriate is usage of DNA isolation kits; 3. In case of equivocal results two independent molecular methods should be employed, one of them should be direct sequencing; 4. It is recommended to extend the panel of analyzed exons to 18, 19, 20 and 21; 5 The turnaround time (TAT) should not take more than 10 working days
Onkol. Prak. Klin. 2011; 7, 3: 138–145
Get Citation

Keywords

lung cancer; EGFR mutations; EGFR mutational status; targeted therapy; molecular diagnostic

About this article
Title

Validation of selected medical centers involved in molecular diagnostics of cancer in the field of EGFR1 mutations determination

Journal

Oncology in Clinical Practice

Issue

Vol 7, No 3 (2011)

Article type

Research paper

Pages

138-145

Published online

2011-08-23

Bibliographic record

Onkol. Prak. Klin 2011;7(3):138-145.

Keywords

lung cancer
EGFR mutations
EGFR mutational status
targeted therapy
molecular diagnostic

Authors

Andrzej Tysarowski
Dariusz Kowalski
Oksana Kowalczuk
Lech Chyczewski
Ewelina Antoszewska
Janusz Limon
Artur Kowalik
Stanisław Góźdź
Paweł Krawczyk
Łukasz Łaczmański
Anna Szumera-Ciećkiewicz
Włodzimierz P. Olszewski
Maciej Krzakowski
Janusz A. Siedlecki

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