2018 Standard 4.6 Monitoring Compliance with Evidence-Based Guidelines PRIMARY SITE: STAGE IV NON-SMALL CELL LUNG CANCER Prepared by: Kelvin Raybon, MD, FACP, Medical Director, Center for Cancer and Blood Diseases including lung cancer. The Programmed Death Ligand – 1 (PD-L1) receptor is a down-regulating signal on cytotoxic T lymphocytes; prominent expression of PD-L1 by cancers allows avoidance of recognition and attack by T lymphocytes due to this self-recognition checkpoint. Monoclonal antibodies directed toward either the PD-L1 ligand or its receptor block this checkpoint, allowing greater immune recognition and destruction of tumor. Checkpoint inhibiting monoclonal antibodies have revolutionized the care of non-small cell lung cancer, initially as second-line therapy beyond chemotherapy, and subsequently as first line treatment in cancers that highly express the PDL1 ligand, with or without the addition of chemotherapy. Assays to detect high expression of PD-L1 are therefore useful in treatment selection, and are currently recommended in all lung cancer patients with advanced disease that are candidates for therapy. In this study, we report the initial evaluation and pretreatment studies, testing for molecular mutations and PD-L1 expression, and initial treatment in all newly diagnosed Stage IV lung cancer patients, squamous and nonsquamous, for the year 2017. Goals were to assess the alignment of care with national guidelines, and the impact of cancer testing on therapy, as well as to identify any barriers in care management . Introduction Lung cancer remains the number one cause of cancer death in both men and women in 2018. Although a new approach to early diagnosis with low-dose CT scan lung cancer screening is now available, the majority of lung cancer patients currently present or recur with widely metastatic disease that is incurable. Therefore, most lung cancer therapy remains focused on palliation of symptoms and prolongation of survival with systemic drug therapy. Encouragingly, advances have been made. Since the discovery of the EGFR mutation in 2004, research has increasingly identified subgroups of nonsquamous lung cancers that are “driven” by specific mutations that give the cancer its growth advantage. These molecularly driven forms of lung cancer, often seen in nonsmokers, have allowed the development of drugs specifically targeting these mutations, resulting in treatments that are not curative, but more efficacious and less toxic than traditional chemotherapy. EGFR, ALK, ROS-1 and BRAF represent the currently recognized and targeted molecular mutations in lung cancer. Likewise, research in just the last few years has shown the importance of immune surveillance in the persistence and spread of many cancers, Monitoring Compliance with Evidence-Based Guidelines Current standard of care (NCCN Non-Small Cell Lung Cancer v4.2018) suggests that Stage IV lung cancer patients that are candidates for systemic treatment should be tested for the presence of any mutations that are the targets for currently available therapeutic agents and expression of PD-L1 ligand to help select their optimum treatment. However, specific recommendations have changed rapidly in the last two years; challenging all care providers to remain abreast evidence-based recommendations. Summary of NCCN Lung Cancer Targeted Testing Guideline Recommendations with date of revision: V7.2015 – EGFR and ALK – July 2015 V5.2017 – EGFR, ALK, and PD-L1 – May 2017 V8.2017 – EGFR, ALK, ROS-1, and PD-L1 – August 2017 V2.2018 – EGFR, ALK, ROS-1, BRAF, and PD-L1 – February 2018 continued on page 8 AUGUSTA HEALTH • CANCER PROGRAM ANNUAL REPORT 7
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