miss out on the benefits of erlotinib treatment. In the current scenario all patients are offered platinum-based doublet chemotherapy as a first-line treatment and do not undergo screening for EGFR gene mutation status. Erlotinib is offered to unselected patients as a second or third-line treatment. Different EGFR gene mutation testing methods are likely to provide varying levels of accuracy. Sanger sequencing is considered highly accurate in identifying mutations, it can also be insensitive when the proportion of tumour cells in the sample is low. A systematic assessment of EGFR gene mutation screening methods would be beneficial to the consideration of this application. Additionally, assessment of the effects of artefacts resulting from FFPE and other preparation procedures on DNA sequence would be useful. Figure 3 illustrates the current scenario on the left-hand panel, and the proposed base case scenario in the centre panel. The right hand panel illustrates the alternative scenario in which the testing of tumour samples only occurs once the patient has otherwise become eligible for erlotinib treatment (disease has already progressed to stage IIIB or IV).
miss out on the benefits of erlotinib treatment. In the current scenario all patients are offered platinum-based doublet chemotherapy as a first-line treatment and do not undergo screening for EGFR gene mutation status. Erlotinib is offered to unselected patients as a second or third-line treatment. Different EGFR gene mutation testing methods are likely to provide varying levels of accuracy. Sanger sequencing is considered highly accurate in identifying mutations, it can also be insensitive when the proportion of tumour cells in the sample is low. A systematic assessment of EGFR gene mutation screening methods would be beneficial to the consideration of this application. Additionally, assessment of the effects of artefacts resulting from FFPE and other preparation procedures on DNA sequence would be useful. Figure 3 illustrates the current scenario on the left-hand panel, and the proposed base case scenario in the centre panel. The right hand panel illustrates the alternative scenario in which the testing of tumour samples only occurs once the patient has otherwise become eligible for erlotinib treatment (disease has already progressed to stage IIIB or IV).
1173-Final-DAP-EGFR-for-erlotinib-accessibleFINAL.docx