EGFR mutation testing practices within the Asia Pacific region: results of a multicenter diagnostic survey.
BACKGROUND
The efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in EGFR mutation-positive non-small-cell lung cancer (NSCLC) patients necessitates accurate, timely testing. Although EGFR mutation testing has been adopted by many laboratories in Asia, data are lacking on the proportion of NSCLC patients tested in each country, and the most commonly used testing methods.


METHODS
A retrospective survey of records from NSCLC patients tested for EGFR mutations during 2011 was conducted in 11 Asian Pacific countries at 40 sites that routinely performed EGFR mutation testing during that period. Patient records were used to complete an online questionnaire at each site.


RESULTS
Of the 22,193 NSCLC patient records surveyed, 31.8% (95% confidence interval: 31.2%-32.5%) were tested for EGFR mutations. The rate of EGFR mutation positivity was 39.6% among the 10,687 cases tested. The majority of samples were biopsy and/or cytology samples (71.4%). DNA sequencing was the most commonly used testing method accounting for 40% and 32.5% of tissue and cytology samples, respectively. A pathology report was available only to 60.0% of the sites, and 47.5% were not members of a Quality Assurance Scheme.


CONCLUSIONS
In 2011, EGFR mutation testing practices varied widely across Asia. These data provide a reference platform from which to improve the molecular diagnosis of NSCLC, and EGFR mutation testing in particular, in Asia.
*Department of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan; †Department of Pathology, Aberdeen University Medical School, Aberdeen, United Kingdom; ‡KalGen Laboratory, Stem-cell and Cancer Institute (SCI), Jakarta, Indonesia; §School of Medicine, Monash University Malaysia & Sime Darby Medical Center, Kuala Lumpur, Malaysia; ‖Center for Gene and Protein Research, Hanoi Medical University, Hanoi, Vietnam; ¶Department of Pathology, Fudan University Shanghai Cancer Center; Institute of Pathology, Fudan University, Shanghai, China; #Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; **Research and Biotechnology Division, St. Luke's Medical Center, Quezon City & COS-CENSER, De La Salle University, Manila, Philippines; ††Department of Pathology, National Cancer Center, Goyang-si, Gyeonggi-do, Korea; ‡‡Department of Pathology, Singapore General Hospital, Singapore, Singapore; §§Chulalongkorn GenePRO Center, Chulalongkorn Hospital, Bangkok, Thailand; ‖‖Seoul National University Bundang Hospital, Seoul, Korea; ¶¶Department of Respiratory Medicine, Saitama Medical University, Saitama, Japan; ##Peking Union Medical College Hospital, Beijing, China; ***Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, Naples, Italy; †††Division of Hematology/Oncology, Innovative Cancer Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; ‡‡‡Clinical Genomic Medicine/Thoracic Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; §§§Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; ‖‖‖University of Melbourne, Melbourne, VIC, Australia; ¶¶¶Sun Yat-Sen University Cancer Center, Guangzhou, China; ###Personalised Healthcare, AstraZeneca, Macclesfield, United Kingdom; ****Clinical Science Division, Astr
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D000230:Adenocarcinoma / Q000175:diagnosis / Q000453:epidemiology / Q000235:genetics*; D001208:Asia / Q000453:epidemiology; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000453:epidemiology / Q000235:genetics*; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000453:epidemiology / Q000235:genetics*; D004252:DNA Mutational Analysis / Q000379:methods*; D004273:DNA, Neoplasm / Q000235:genetics; D016208:Databases, Factual; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000235:genetics*; D008297:Male; D009154:Mutation / Q000235:genetics*; D009367:Neoplasm Staging; D010139:Pacific Islands / Q000453:epidemiology; D016133:Polymerase Chain Reaction; D011379:Prognosis; D011933:Reagent Kits, Diagnostic; D012189:Retrospective Studies
D004273:DNA, Neoplasm; D011933:Reagent Kits, Diagnostic; C512478:EGFR protein, human; D066246:ErbB Receptors