Overcoming Barriers to Molecular Testing in NSCLC Care: Jorge Nieva, MD

At a recent Institute for Value-Based Medicine® event, Jorge Nieva, MD, associate professor of clinical medicine at Keck School of Medicine of the University of Southern California in Los Angeles, discussed the evolving role of molecular testing in the management of non–small cell lung cancer (NSCLC). He emphasized how biomarker testing has become essential to guiding individualized treatment decisions, given the diverse molecular drivers that define NSCLC subtypes.

Nieva also outlined the persistent challenges facing clinicians, from difficulties in obtaining adequate tissue samples for next-generation sequencing to delays in turnaround times, and highlighted the need for more accessible, faster diagnostic technologies that can support timely and precise care for patients.

This transcript was lightly edited; captions were auto-generated.

Transcript

How are clinicians incorporating molecular testing into NSCLC care today?

Tissue and blood biomarker testing has become essential to the care of patients with non–small cell lung cancer. Non–small cell lung cancer is not one disease; it is a group of many diseases, each of which has a unique molecular driver, and each of those entities needs to be treated differently. We now have a large panoply of different drugs that act on various molecular and genomic pathways. It is essential that all lung cancer patients have a very clear understanding of what subtype of lung cancer they have, based on their molecular genetic profile, and that treatment be tailored to the specific features of that tumor.

What barriers still limit timely testing and widespread access, especially when positive markers may exclude patients from periooperative immunotherapy?

Lung cancer is one of the most difficult tumor types to get good tissue from. It is risky in many ways to put needles into the lungs, because they have a tendency of collapsing, and as a result of that, the majority of lung cancer pathological specimens that we have tend to be small. Currently in the community, the vast majority of patients are diagnosed using tissue obtained from transthoracic biopsies through CT guidance, and these are among the most scant and small biopsies that exist for any tumor type—particularly when many community organizations and community radiologists will be using needles of 20-gauge or smaller for safety reasons. That often leads to inadequate tissue for appropriate testing.

Next-generation sequencing in the year 2025 is the standard by which we should be obtaining genomic information on tumors, and next-generation sequencing requires a lot of tissue—about 20 to 25 slides. It is imperative that clinicians in the community understand the best ways of getting tissue for our patients.

Currently, we’ve done some research, and we know that bronchoscopically obtained tissue tends to be larger and has a higher success rate for next-generation sequencing. But the practitioners who obtain bronchoscopic biopsies in large chunks tend to be interventional pulmonologists, and interventional pulmonologists are somewhat rare. They don’t exist in every state in the United States, and they may be hard to access for many areas, particularly rural areas. I think adequacy of tissue is the number one barrier that we have.

The second barrier, of course, is that next-generation sequencing is slow. It takes about 2 weeks from the time tissue arrives at a lab, gets amplified, goes into the sequencer, gets bioinformatics done, and issues a result. For many cancer patients, that 2 weeks is excruciating because you know you have cancer, you know that it’s bad, and you don’t know what your treatment is going to look like or what your prognosis is going to be until this black box information comes out. That’s a problem for many patients as well, and it makes it imperative that we begin to develop technologies that can give us faster, quick turnaround information that can be done locally on relatively small tissue quantities.

A lot of work has been done in that area. It’s not quite ready today, but I expect that it will be ready relatively soon, and I think it will be an advance in the future.