Shirley Michelle Shiller, DO, discusses the application of biomarkers and the importance of educating practitioners on treatment advancements in NSCLC.
Shirley Michelle Shiller, DO
The advancements in the treatment paradigm of non—small cell lung cancer (NSCLC) stem from the development of biomarker-driven therapy, liquid biopsies, and effective single-agent immunotherapy and combination regimens.
However, as the diagnoses within the world of lung cancer become more diversified, the need for healthcare provider overlap and communication becomes more important than ever, according to Shirley Michelle Shiller, DO.
“There has never been another time in medicine greater than right now, in which we really need to be working together,” said Shiller. “We need to better communicate and talk with the clinicians, specifically the oncologist, pulmonologist, thoracic surgeon, interventional radiologist, and pathologist. The more we talk, the greater we can get a higher yield for the patient. By doing this, we will be able to get the result and consequent treatment to patients sooner, confident that it is right for them.”
In an interview during the 2018 OncLive® State of the Science SummitTM on Non—Small Cell Lung Cancer, Shiller discussed the application of biomarkers in treatment and the importance of educating practitioners on treatment advancements in NSCLC.Shiller: This talk focused on helping our clinical colleagues understand some of the methods that are behind getting them the test results that drive the targeted therapy downstream. There's a large gap in education in terms of the techniques that are utilized at the molecular level and the results that they get. There's a lot of complexity, there are a lot of ways to do it, and now is the time to help them feel empowered with that information.PD-L1 is a good biomarker in terms of assessing immunoexpression. The thing that is unique about it versus looking at EGFR or KRAS is that the immune system is always in flux, so it occurs along a continuum. The results of it can vary not only within one specimen on its own, but also within separate time points. It’s reliable in terms of knowing it’s being expressed, but the expression can widely vary. Some of the major challenges we are facing are, first and foremost, the FDA issuing companion diagnostics without really engaging the pathologist in terms of its performance characteristics. We also need to work together to streamline which markers we are using for PD-L1, as an example. Though there are FDA companion diagnostics in other spaces, for years the testing was also done in labs throughout the country with similar results that weren't overseen, governed, or given a companion diagnostic designation by the FDA.
We need to develop a better level of communication with the FDA in terms of the performance of our assays and help them understand that we are already governed by 2 other parties. Having a third party come into the mix may or may not be needed, depending on the actual biomarker and how it’s going to be used. Every physician should be testing for EGFR, ALK, BRAF, ROS1, and PD-L1. In the PD-L1 space, the KEYNOTE data were very critical in driving the interpretation in how the actual expression of PD-L1 correlated with patients’ responses to drugs and in what line of treatment. T790M as a biomarker at the time of progression has been outstanding, and the drug which parallels it is an outstanding-performing drug not only for T790M, but also for targeting the initial EGFR resistance mutation. The same thing is true with EGFR; that's a tremendous success story, as well. The liquid biopsy is an outstanding alternative. The main thing we keep in mind with the liquid biopsy is that if you have a negative—specifically if you're in the setting of a patient who had an EGFR mutation and now they're progressing—then if there's any way the patient can tolerate a procedure, [they should] get tissue. It’s strongly recommended and vice versa. If you start off with tissue and you get a negative, go to plasma. Plasma is a wonderful option, especially for that very sick patient, and you can sometimes get results in a manner of a couple of days. The next steps are to continue doing exactly what OncLive is doing here [at this meeting] and offering opportunities to sit down and talk amongst our colleagues and educate and understand what it is that they need, so we can get that to them more effectively.
We also need to work with regulatory agencies, not only the client assistance program, but also the FDA to help them understand what we do as laboratorians and how we interpret things. Sometimes we need to look at something a little more scientifically and have the imprint of someone who has the experience of working with those tests to help direct them in terms of testing recommendations that will then guide therapy.