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Epidermal Growth Factor Receptor(EGFR) Mutation test for patients with Non-small cell lung cancer (NSCLC) [Adapted from the report by Dr.Ana Fizalinda Abdullah Sani] Introduction Review Group Membership MaHTAS Reviewer: Ku Nurhasni Ku Abd Rahim Dr. Ana Fizalinda Abdullah Sani Dr. Izzuna Mudla M.Ghazali Datin Dr. Rugayah Bakri External Reviewer: Dr Jamallul Azizi A. Rahman Dr Adlinda Alip Disclaimer: Technology review is a brief report, prepared on an urgent basis, which draws on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It is not subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. For further contact: information please Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex 62590 Putrajaya. Tel: 603 8883 1246 Lung cancer has been identified as the most common cancer among males and third most common cancer in the general population. Non-small-cell lung cancer (NSCLC) is the most common form of lung cancer and has three main histological subtypes which are squamous cell carcinoma, adenocarcinoma and large cell carcinoma. There were 1,865 cases of lung cancer diagnosed in 2007 and registered at NCR, comprising of 1,320 males and 545 females. The Agestandardised Rates (ASR) for male was 14.7 per 100,000 population and 5.6 per 100,000 population for female. However, EGFR mutation test are not routinely performed in patients with nonsmall-cell lung cancer in most East Asian medical centers, hospital, or clinics. Among the identified potential barriers to EGFR mutation testing in most East Asian countries are the cost of the EGFR mutation test, challenges in the specimen acquisition, availability of experience clinical pathologists for the required tests and number of laboratories capable of performing the test in each country. Objective/Aim The objective of the technology review was to review the clinical effectiveness and diagnostic performance of EGFR mutation testing to detect the presence of EGFR mutations in patients with non-small cell lung cancer (NSCLC). Results and Conclusions There were two systematic review studies, one diagnostic study and 11 observational studies included in this review. In addition, there was one economic evaluation study retrieved from the scientific databases. Based on the above review, there were fair to good level of evidence that suggest epidermal growth factor receptor (EGFR) mutation test contribute to the delivery of personalised cancer treatment plans by identifying the suitable patients for treatment with tyrosine kinase inhibitor with promising clinical effectiveness such as better overall response, overall survival and progression-free survival. The evidence suggested that EGFR mutations were detected more frequently in women, non smokers and in patients with histology result of adenocarcinoma. Fax: 603 8883 1230 Available at the following website: http://www.moh.gov.my 2013 A variety of methods have demonstrated to be potential alternatives to the historical standard for EGFR mutation testing, namely direct sequencing. However, the only choice of the testing methods should based on local setting whether detection of known activating EGFR mutations only or all possible mutations is required, the availability of the equipment and laboratory’s expertise, availability of sample and cost. In order to maximize the benefit of the EGFR mutation test for local population, proper selections of patients need to be taken into consideration as ethnicity, sex and smoking status were reported to be associated with EGFR mutation. Methods Scientific electronic databases were searched through OVID interface which include OVID MEDLINE (R) In process &Other Non-Indexed Citations and OVID MEDLINE (R) 1946 to present, Cochrane Central Register of Controlled Trials June 2013, Cochrane Database of Systematic Reviews 2005 to May 2013, EBM Reviews- Database of Abstracts of Reviews of Effects 2nd Quarter 2013, EBM Reviews- Health Technology Assessment 2nd Quarter 2013, EBM Reviews- NHS Economic Evaluation Database 2nd Quarter 2013, EBM reviews-ACP journal Executive Summary Club1991-June 2013, EBM Reviews-Cochrane Methodology Register 3rd Quarter 2012, Embase and Pubmed. Last search was done on 15th August 2013 and there was no limitation during the search. Relevant articles were critically appraised using Critical Appraisal Skills Programme (CASP) checklists. Evidence was graded according to the US / Canadian Preventive Services Task Force and NHS Centre for Reviews and Dissemination (CRD) University of York, Report Number 4 (2nd Edition). Executive Summary