NCCN Releases CAR-T Cell Guidelines for Patients with Cancer

The National Comprehensive Cancer Network (NCCN) recently released new guidelines to try and aid patients with cancer in understanding CAR-T cell therapy and its accompanying side effects.

The guidelines are intended to help patients answer any questions they may have about CAR-T cells, and also give patients an idea of what to anticipate if their physician recommends CAR-T cell therapy.

In an interview with CancerNetwork®, Jordan Gauthier, MD, MSc, a physician at the Seattle Cancer Care Alliance, an assistant professor in the Clinical Research Division at Fred Hutch, a professor in the Division of Medical Oncology at the University of Washington School of Medicine, and a physician at UW Medicine, spoke about these new guidelines and what they offer patients with cancer.

CancerNetwork®: First off, can you just explain what the new NCCN guidelines on CAR-T cells for patients include?

Gauthier: So, it's a fairly comprehensive document that really sets the stage of introducing what CAR-T cell therapy is [by] reviewing the currently available CAR-T cell products; there's only 2 products to date that are FDA approved, that can be given commercially. And so, the first section gives an overview of really what's the whole process from cell collection, the engineering of the cells in the lab, and then the re-infusion into the patient. Then we have basically another overview of the common side effects, namely cytokine release syndrome [and] neurologic toxicity that we also called [immune effector cell-associated neurotoxicity syndrome; ICANS], which is a type of encephalopathy. That can happen after CAR-T cell therapy. So those are the 2 main sections. And then we have also a few words on other complications that can occur, and in particular low blood counts. So… the need for transfusions and growth factors after treatment. And the final section is a list of resources and questions to ask your physician about and a list of websites with very nice and important resources. I kind of like the list of questions as well, I think it can kind of spur some inspiration for patients that don't really know what to ask.

So, what was the goal of publishing these new guidelines?

So, it looks like the main goal is really to give that overview and the key to focus on these 2 main complications that are cytokine release syndrome and neurologic toxicity for patients to have a really, really good understanding of what can happen. And what are the treatments for this, what to expect, really what kind of symptoms they can experience. The only thing that would have been nice is to give a range of numbers, for example, what is the raw percentage? So, I think it would have been informative for patients to know roughly, what's the percentage of cases and for these different toxicities. So that's, I guess that's really the main role is to provide. And it's fairly comprehensive and quite in depth for patients. So, they really go into detail about what serious events can happen and what other kinds of signs and symptoms are associated with these toxicities.

Moving forward, how often do you think that these guidelines will be updated?

I think they will be updated quite frequently, because this is still early days for these new treatments. There's only 2 products, and mainly one that's commonly prescribed and used in adult patients which is [axicabtagene ciloleucel; Yescarta]. [Tisagenlecleucel; Kymriah], they've been having a lot of problems making the product for adult patients in particular. So, I think this is still early days, and we are still learning, and we have more and more data, but I expect that as new copies of products get approved in the future and we start targeting other antigens in solid tumors, for example… Right now, the indication, as you know, is very, very narrow, very restricted to B-cell malignancies; in particular [acute lymphocytic leukemia; ALL] and large B-cell lymphomas. But in the future, we may have new products for other types of cancer, and particularly solid tumors and different toxicities as well in these cases because we expect some of these toxicities to be antigen dependent. So, as we target other antigens, things may change. We may see, hopefully not too many, but some different distinct side effects. So, I can’t give you… I don't know if it's going to be every year, but there will be some frequent reviews and updates of this document for sure.

Reference:

NCCN. Immunotherapy Side Effects: CAR T-Cell therapy. NCCN website. Published 2020. nccn.org/patients/guidelines/content/PDF/immunotherapy-se-car-tcell-patient.pdf. Accessed July 15, 2020.