Dr Leonard B. Saltz on Deciding When a Patient Should Receive NGS Testing

There is going to be an increased use of next generation sequencing testing, and the challenge is going to be to figure out when and how, said Leonard B. Saltz, MD, executive director of Clinical Value and Sustainability, head of Colorectal Oncology Section, Memorial Sloan Kettering Cancer Center.

How do you decide when a patient should receive next-generation sequencing testing?
That’s not as straightforward of a question as you might think, and I think that’s a question for which the answer is evolving. At Memorial Sloan Kettering, we’ve had a longstanding interest in this approach. We have an in-house assay that we’ve been leveraging both to try and help individual patients, as well as to understand the biology of tumors. So, perhaps our practice is somewhat difference than what can be expected to be out there in general practice.

Now that there is at least 1 assay commercially available that’s FDA approved and a number FDA authorized, I think we’re going to see an increased use of the technology and our challenge is going to be to figure out when and how. I would argue that we don’t really know how to use it for early-stage disease, and I don’t think that’s the right place to do it.

I think that at the initiation of treatment for metastatic disease would be the most value added time to think about using next-generation sequencing to try and understand what our options are. It’s important to take a look at what’s covered because not only does the assay itself cost money, but the results of the assay are going to cost money.

Right now, as I read the approval, it’s covered as kind of a 1-shot deal. It’s not a sequential process. So, I think getting that information early on in the strategizing of how you’re going to approach the patient with metastatic disease makes the most sense.

If a patient is tested and there is no available targeted therapy for them to be matched with, can the patient still benefit from the test?
Of course the easiest thing is if we find a mutational profile that tells us there’s a high probability of benefit from a current commercially available drug. That’s perhaps the best-case scenario. The next would be if we see something that suggests an investigational approach, if there is availability of that investigational approach. Now, that would require that there be a clinical trial, that the clinical trial have openings, and that the patient be well enough to be treated on that trial.

One of the things I worry about is patients are imbuing this concept of precision oncology with almost magical ability, and there’s a bit of magical thinking going on in terms of what it might offer. Everybody wants to believe that they’ll have seen 4 or 5 doctors that tell them there really isn’t more to be done, that hospice care is appropriate, and that the next one is going to do some precision medicine and cure them.

That’s not going to happen in the overwhelming majority of people, and the question of whether it happens at all is really suspect. It depends on how sick the individual is. Once a person gets to the point where they’re too sick for clinical trials, they’re often too sick to tolerate or benefit from therapies, and that’s something that we have to bear in mind.
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