1. Type of survey This is a retrospective survey that will NOT require the disclosure of any individual patient records or data only information about overall EGFR mutation testing practices and the outcomes of these tests carried out in the participating laboratories. This online (electronic) survey contains twenty four simple questions. Those marked with an asterisk () must be answered. The survey should be completed by laboratory personnel e.g. pathologist, oncologist or laboratory head, who has authorized access to the data source from which they are required to answer the survey questions. Page 1
2. Survey objectives 1. To obtain data on the current status of EGFR mutation testing across twelve Asian countries, in terms of types of mutation test, sample types, sample preparation, logistics of test request, sample shipment, and result reporting, in order to be used as baseline information for possible improvements to ideal EGFR mutation testing practice 2. To obtain the number of non small cell lung cancer (NSCLC) patients who were tested for EGFR mutations in surveyed sites in order to estimate the number of NSCLC patients who are tested for EGFR mutations in the participating countries in Asia Pacific 3. To estimate the frequency of EGFR mutation positivity in: the overall EGFR tested NSCLC population histological subtypes of EGFR tested NSCLC demographic subgroups (gender, smoking status) 4. To estimate the proportion of NSCLC patients who are tested for EGFR mutations in the participating countries in Asia Pacific 5. To determine which EGFR mutation testing methods are most commonly used in the participating countries 6. To evaluate the source of the data captured and to utilize this information for interpretation Page 2
3. Minimum requirements for participating sites Sites should have access to a laboratory which performs EGFR mutation testing for clinical purposes, at the request of a treating physician/pathologist Must have tested at least 100 NSCLC cases for EGRF from January December 2011, or if for a given country no site can meet that criteria, sites with the highest numbers of EGFR testing will be surveyed Must have access to data sources containing information about the NSCLC population (number of cases diagnosed and tested, histology, test results) e.g. databases Page 3
4. Information about the EGFR mutation testing laboratory Please provide the following details Contact Name: Company/Laboratory Name (if applicable): Hospital Name (if applicable): City/Town: State/Province (if applicable): Country: Email Address: Phone Number: Page 4
5. Information about the EGFR mutation testing laboratory Please specify your type of laboratory: Commercial (independent from hospital) Laboratory only tests samples from your own hospital Laboratory tests samples from your own and other hospitals Is your laboratory accredited or does it participate in a Quality Assurance Programme? (Please tick all that apply) gfedc gfedc gfedc gfedc None Accredited by local accrediting body Accredited by international accrediting body Participates in a Quality Assurance programme Page 5
6. Information about NSCLC population and proportion tested for EGFR mutations The purpose of this survey is to determine the proportion of non small cell lung cancer (NSCLC) patients that are being tested in your country, as well as the frequency of EGFR mutation positivity. Hence, we need to be able to estimate the TOTAL number of NSCLC patients diagnosed. In the following section, you will first be asked to provide some information about the NSCLC population that is being tested; i.e. the total number of patients diagnosed with NSCLC in 2011 in the hospitals you serve, and their characteristics. (If you do not know the total number of patients diagnosed with NSCLC in the hospitals you serve, you can answer 'Not known'.) Then you will be asked how many of these NSCLC patients were tested for EGFR mutations in 2011 in your laboratory. Finally, you will be asked how many of the EGFR mutation tests were positive. Page 6
7. Information about the NSCLC population that is tested for EGFR mutations What is the total number of NSCLC cases NEWLY DIAGNOSED in the hospital(s) from which you received samples for EGFR mutation testing during January December 2011? (If the number is not known, please type 'Not known' in the relevant box) Squamous cases are also non adenocarcinoma cases. If the data are available, please report here the number of patients who are both non adenocarcinoma AND squamous cases Total number of NSCLC cases newly diagnosed during January December 2011 Number of adenocarcinoma cases diagnosed Number non adenocarcinoma cases diagnosed Number of squamous cell carcinoma cases diagnosed Number of male patients diagnosed Number of female patients diagnosed Number of current/ex smoker patients diagnosed Number of never smoker patients diagnosed Number of biopsy and/or cytology samples diagnosed Number of surgical specimen samples diagnosed Page 7
8. Information about the samples tested for EGFR mutations What is the total number of NSCLC cases TESTED FOR EGFR MUTATIONS in your laboratory during January December 2011? (If the number is not known, please type 'Not known' in the relevant box) Squamous cases are also non adenocarcinoma cases. If the data are available, please report here the number of patients who are both non adenocarcinoma AND squamous cases Total number of NSCLC cases tested during January December 2011 Number of adenocarcinoma cases tested Number non adenocarcinoma cases tested Number of squamous cell carcinoma cases tested Number of male patients tested Number of female patients tested Number of current/ex smoker patients tested Number of never smoker patients tested Number of biopsy and/or cytology samples tested Number of surgical specimen samples tested Page 8
9. Information about the samples tested for EGFR mutations How many samples tested for EGFR mutation during 2011 were from the following sites? (Please type 'Not known' in the box if you do not know the answer) Number of samples from primary tumour Number of samples from metastatic site (including pleural effusion) Number of samples from unknown site How many samples tested for EGFR mutation during 2011 were CYTOLOGY samples? (Please type 'Not known' in the box if you do not know the answer) Number of cytology samples Page 9
10. Information about the samples that tested positive for EGFR mutations What is the number of cases that were POSITIVE FOR EGFR MUTATIONS in your laboratory from January December 2011? (Please type 'Not known' in the box if you do not know the answer) Squamous cases are also non adenocarcinoma cases. If the data are available, please report here the number of patients who are both non adenocarcinoma AND squamous cases TOTAL number of samples that were positive for EGFR mutations during January December 2011 Number of EGFR mutation positive adenocarcinoma cases Number EGFR mutation positive non adenocarcinoma cases Number of EGFR mutation positive squamous cell carcinoma cases Number of EGFR mutation positive male patients Number of EGFR mutation positive female patients Number of EGFR mutation positive current/ex smoker patients Number of EGFR mutation positive never smoker patients Number of EGFR mutation positive biopsy and/or cytology samples Number of EGFR mutation positive surgical specimen samples What is the total number of cases tested where the test failed or did not yield a clear result and the EGFR mutation status was judged to be undetermined? (Please type 'Not known' in the box if you do not know the answer) Total number of undetermined cases Page 10
11. Information about sample processing How often is IHC used to predict the subtypes of samples with poorly differentiated morphology? Routinely (regularly, or on a daily basis) Occasionally (every now and then, not often) Not known Do you receive a copy of the pathology report issued for the EGFR mutation testing sample when it arrives at your laboratory? Yes Sometimes No If you receive a copy of the pathology report with the sample, does information on the percentage tumour content or other assessment of sample quality accompany the sample to the testing lab? Yes Sometimes No Page 11
12. Information about EGFR mutation testing methods used in your laboratory You will now be asked which EGFR mutation testing methods you most commonly use for TISSUE samples, and then which methods you most commonly use for CYTOLOGY samples. You will be asked to rank up to three methods in order of how frequently they are used in your laboratory. If you only use one (or two) method(s), there is no need to select a second/third method. If you do not test cytology samples for EGFR mutations, please select the option "This laboratory does not test cytology samples" under the question about cytology samples. Page 12
13. Information about EGFR mutation testing methods used What is the most common EGFR mutation testing method used in your laboratory for TISSUE samples? (Please choose up to three answers and rank them in order of frequency used: most common method, second most common, third most common) Second most Third most common Most common method common method method DNA sequencing Commercial in vitro diagnostic kit (select which kit): Therascreen EGFR RGQ PCR Kit (QIAGEN) EGFR29 Mutation detection kit (AMOY) Cobas EGFR Mutation Test (Roche) PNAClamp Mutation detection kit (Panagene) Therascreen EGFR Pyro Kit (QIAGEN) Other commercial in vitro diagnostic kit Other laboratory developed method (select which method): PNA LNA PCR clamp PCR INVADER Cycleave Other laboratory developed method Page 13
14. Information about EGFR mutation testing methods used What is the most common EGFR mutation testing method used in your laboratory for CYTOLOGY samples? (Please choose up to three answers and rank them in order of frequency used: most common method, second most common, third most common) Second most Third most common Most common method common method method DNA sequencing Commercial in vitro diagnostic kit (select which kit): Therascreen EGFR RGQ PCR Kit (QIAGEN) EGFR29 Mutation detection kit (AMOY) Cobas EGFR Mutation Test (Roche) PNAClamp Mutation detection kit (Panagene) Therascreen EGFR Pyro Kit (QIAGEN) Other commercial in vitro diagnostic kit Other laboratory developed method (select which method): PNA LNA PCR clamp PCR INVADER Cycleave Other laboratory developed method This laboratory does not test cytology samples for EGFR mutations Page 14
15. Reason for selecting the EGFR mutation testing method(s) you use What is the main reason for selecting the particular EGFR mutation testing methods used in your lab? (Select three reasons in order of importance) Most important Second most important Third most important Available equipment Cost Sensitivity ability to detect mutations at a low level Easy to use Quality controlled Range of mutations detected Page 15
16. Cost of EGFR mutation testing What is the total or overall average cost per test to your lab? (Defined as a fully inclusive cost to the system from sample receipt to reporting, to include DNA extraction and mutation analysis.) < 50 USD 50 200 USD 200 500 USD > 500 USD Page 16
17. Information about turnaround time for EGFR mutation testing What is the turnaround time in your laboratory, defined as the time from receipt of sample in your laboratory, to sending out the report? < 5 days 5 10 days 11 15 days > 15 days Page 17
18. Other biomarker tests on NSCLC samples Are other molecular biomarkers associated with NSCLC targeted treatments, such as KRAS mutations or ALK translocation, tested for in your laboratory? KRAS Yes No ALK Yes No Page 18
19. Information about how records used for this survey are captured and stored What is the source of the records used for this survey? (Please tick all that apply) gfedc gfedc gfedc gfedc gfedc Laboratory electronic Hospital electronic Laboratory paper based Hospital paper based Other not listed Page 19
20. Information about paper based records You only need to answer the questions on this page if you will use paper based records (from any source) to help you complete this survey. If you will only use electronic records to complete this survey, please press 'Next' and proceed to the next page. How are the appropriate paper based source records identified for this study? (Please choose one answer) From a central record Through asking each doctor individually Through asking laboratory personnel individually Where are the paper based source records used for this study stored? (Please choose one answer) In a single central location Each doctor stores their own records Each laboratory staff stores their own records Page 20
21. Information about how records used for this survey are captured and stored The questions on this page are designed to help us understand whether any patients could be 'missing' from your records, and also whether data from any patients could have been duplicated. Your answers to these questions will help us with data interpretation. Do the source records surveyed contain data from all available patients? (Please choose one answer) Yes, data from all LABORATORY and all HOSPITAL patients Yes, data from all LABORATORY patients Yes, data from all HOSPITAL patients No Do the source records surveyed collect data consecutively, meaning no patients could be missed? Yes, consecutive data collection means no patients could be missed No, there is a possibility that patients could be missed Is there the possibility of duplicate records amongst the source records surveyed? Yes No Page 21
22. Electronic signature Please enter your name here. This electronic signature confirms that the answers given in this survey are based on data sourced directly from laboratory and/or hospital records. Once you click the 'Done' button below, the survey will be completed and you will no longer be able to enter the survey, or visit previous pages, to edit or change your data. If you are ready to exit the survey, please press 'Done'. Page 22