Consensus Recommendations for Optimizing Biomarker Testing to Identify and Treat Advanced EGFR-Mutated Non-Small-Cell Lung Cancer

Abstract

The advent of personalized therapy for non-small-cell lung carcinoma (nsclc) has improved patient outcomes. Selection of appropriate targeted therapy for patients with nsclc now involves testing for multiple biomarkers, including EGFR. EGFR mutation status is required to optimally treat patients with nsclc, and thus timely and accur­ate biomarker testing is necessary. However, in Canada, there are currently no standardized processes or methods in place to ensure consistent testing implementation. That lack creates challenges in ensuring that all appropriate biomarkers are tested for each patient and that the medical oncologist receives the results for making informed treatment decisions in a timely way.
 An expert multidisciplinary working group was convened to create consensus recommendations about biomarker testing in advanced nsclc in Canada, with a primary focus on EGFR testing. Recognizing that there are biomarkers beyond EGFR that require timely identification, the expert multidisciplinary working group considered EGFR testing in the broader context of integration into complex lung biomarker testing. Primarily, the panel of experts recommends that all patients with nonsquamous nsclc, regardless of stage, should undergo comprehensive reflex biomarker testing at diagnosis with targeted next-generation sequencing. The panel also considered the EGFR testing algorithm and the challenges associated with the pre-analytic, analytic, and post-analytic elements of testing. Strategies for funding testing by reducing silos of single biomarker testing for EGFR and for optimally implementing the recommendations presented here and educating oncology professionals about them are also discussed.

Next Generation Sequencing Technology in Lung Cancer Diagnosis

“…The same was observed by Mack et al when analyzing 8388 cases of NSCLC [ 65 ]. NGS testing was successfully recommended in lung cancer diagnosis by different expert panels [ 66 ] and oncology organizations [ 67 ]. Gray et al performed a thorough survey of the relevant literature regarding liquid biopsy and observed that the advantages of NGS have helped to develop different assays using liquid biopsy samples for the early diagnosis, treatment selection, minimal disease detection, monitoring treatment efficacy and evaluation of tumor burden in lung cancer [ 63 ].…”

Molecular testing in stage I–III non-small cell lung cancer: Approaches and challenges

“…The main difficulty in adopting reflex testing is likely to be cost and the reimbursement of those costs by public-funded healthcare systems, particularly if reimbursement is predicated on documented disease stage. Consensus recommendations from a Canadian expert multidisciplinary working group state that all patients with non-squamous NSCLC, regardless of stage, should undergo comprehensive reflex biomarker testing at diagnosis using targeted NGS; however, the group recognized the lack of standard funding for such testing and recommended that provincial reimbursement bodies support comprehensive rather than single gene testing [67]. Author perspectives on our own countries are provided.…”

EGFR Status Assessment for Better Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing in the Daily Practice of Pathologists?

“…The EGFR status of tumors of patients with advanced stage NSCLC can be evaluated with several biological sources: (i) tissue biopsies (of bronchial or transthoracic origin); (ii) cytological samples (from transbronchial or transthoracic fine needle aspiration; fluid effusions, in particular pleural or cerebrospinal; and bronchoalveolar lavage); (iii) blood samples, mostly from circulating free DNA and sometimes from circulating tumor cells (CTCs); and, more rarely, (iv) surgical specimens [27] (Figure 1). All of these samples can also be analyzed in early stage NSCLC for genomic alteration assessment, though, at the moment, the majority probably consist of surgical specimens and, less frequently, biopsies.…”