Biomarker Testing for People With Advanced Lung Cancer in England

Abstract

Introduction: Optimal management of people with advanced NSCLC depends on accurate identification of predictive markers. Yet, real-world data in this setting are limited. We describe the impact, timeliness, and outcomes of molecular testing for patients with advanced NSCLC and good performance status in England. Methods:In collaboration with Public Health England, patients with stages IIIB to IV NSCLC, with an Eastern Cooperative Oncology Group performance status of 0 to 2, in England, between June 2017 and December 2017, were identified. All English hospitals were invited to record information.Results: A total of 60 of 142 invited hospitals in England participated in this study and submitted data on 1157 patients. During the study period, 83% of patients with advanced adenocarcinoma underwent molecular testing for three recommended predictive biomarkers (EGFR, ALK, and programmed death-ligand 1). A total of 80% of patients with nonsquamous carcinomas on whom biomarker testing was performed had adequate tissue for analysis on initial sampling. First-line treatment with a tyrosine kinase inhibitor was received by 71% of patients with adenocarcinoma and a sensitizing EGFR mutation and by 59% of those with an ALK translocation. Of patients with no driver mutation and a programmed death-ligand 1 expression of greater than or equal to 50%, 47% received immunotherapy. Conclusions:We present a comprehensive data set for molecular testing in England. Although molecular testing is well established in England, timeliness and uptake of targeted therapies should be improved.

Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up

“…Similar data has recently been published regarding advanced lung cancer patients in England with 71% of patients receiving TKI therapy on identification of an EGFR mutation 37. It was not clear from their paper which analysis method was used to detect EGFR mutation and they restricted their analysis to patients with a PS of 0, 1 and 2 37. The authors conclude that it is the timeliness of reporting EGFR mutation, in addition to anaplastic lymphoma kinase-1 (ALK-1) and PD-L1 status that is responsible for patients not receiving therapy for which they are eligible 37.…”

“…A study by Ruggiero et al found a similar phenomenon with only 79% of EGFR positive advanced lung cancer patients in the US commenced on appropriate TKI therapy 36. Similar data has recently been published regarding advanced lung cancer patients in England with 71% of patients receiving TKI therapy on identification of an EGFR mutation 37. It was not clear from their paper which analysis method was used to detect EGFR mutation and they restricted their analysis to patients with a PS of 0, 1 and 2 37.…”

“…It was not clear from their paper which analysis method was used to detect EGFR mutation and they restricted their analysis to patients with a PS of 0, 1 and 2 37. The authors conclude that it is the timeliness of reporting EGFR mutation, in addition to anaplastic lymphoma kinase-1 (ALK-1) and PD-L1 status that is responsible for patients not receiving therapy for which they are eligible 37. Furthermore, it was demonstrated in Germany that up to 20% of EGFR mutation positive patients start chemotherapy instead of TKI therapy because they are clinically unable to wait for NGS results to be made available 38.…”

“…Optimal use of tissue will help to prevent the need for re-biopsy of patients which, in the case of CT-guided lung biopsy, for example can come with potentially life-threatening complication of haemoptysis and pneumothorax 42. It is also imperative that pathologists be empowered to make choices regarding the most appropriate method for predictive biomarker testing based on the material in front of them through ‘reflex requesting’ 37. There are myriad options available to pathologists for some markers, such as ALK-1 which include IHC, fluorescence in-situ hybridisation, PCR and RNA sequencing by NGS 37 43.…”

“…It is also imperative that pathologists be empowered to make choices regarding the most appropriate method for predictive biomarker testing based on the material in front of them through ‘reflex requesting’ 37. There are myriad options available to pathologists for some markers, such as ALK-1 which include IHC, fluorescence in-situ hybridisation, PCR and RNA sequencing by NGS 37 43. Sometimes the best choice will be the one that consumes the least amount of tissue.…”