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    Expert Nurse
    Avatar photoKrista Rubin

      ASCO and NCCN released today, their new clinical guidelines for managing immunotherapy-related toxicities. The key guideline recommendations include:

      #) In general, immune checkpoint inhibitors can be continued with close monitoring for mild (grade 1) toxicities, with the exception of neurologic and some hematologic toxicities.

      #) For moderate (grade 2) toxicities, checkpoint inhibitors should be held until symptoms and/or lab values revert to grade 1 levels or lower. Corticosteroids may be offered.

      #) For severe (grade 3) toxicity, patients should receive high-dose corticosteroids for at least 6 weeks. Extreme caution when restarting immunotherapy after a grade 3 toxicity is recommended, if it is restarted at all.

      #) In general, very severe (grade 4) toxicity necessitates stopping checkpoint inhibitor therapy permanently.

      While I think the above general guidelines are prudent to follow, particularly for providers with minimal or limited experience with ICIs, I was surprised to read the 2nd bullet above- holding ICIs for Grade 2 toxicity.

      The way it is currently stated, it would imply that this is the case for ALL toxicities. I agree that certain grade 2 toxicities warrant holding, notably pneumonitis & neuro related, however there are some grade 2 toxicities that would not warrant a hold, such as certain endocrinopathies including hypothyroidism, hypophysitis, etc.

      I believe our care step pathways, available on our site are wonderful resources for nurses in other providers to review at the same time they are familiarizing themselves with the new guidelines from ASCO/NCCN.

      I also find an very interesting that corticosteroid taper guidelines recommend 6 weeks, rather than the standard 4 weeks that has typically been advised.

      I plan to review the guidelines in much more detail in the very near future.

      What are your thoughts?

      Expert Nurse
      Avatar photoLisa Kottschade

        I have not had a chance to review these in detail, but plan to do so as well very soon. I’m a little bit concerned about the “blanket” statements of treating based on the grade only. I’m not sure that we’ve come much further then what the drug companies provided as overall guidance early on and that concerns me for folks in the community who are not used to treating a great number of patients. I agree our care step pathways offer a more in depth set of guidelines for nurses.

        Expert Nurse
        Avatar photoRajni Kannan

          I agree that a generalized way of treating patients based on grading alone is not the best method. Patients irAEs can be so individualized. Colitis may not always be diarrhea, it may abdominal pain and constipation. We have also had patients with grade 3 pancreatitis that are asymptomatic and only were diagnosed due to mandatory study labs that didn’t need the high dose steroids recommended by these guidelines.

          Expert Nurse
          Avatar photoKrista Rubin

            Rajni- you bring up two important points:

            – Asymptomatic elevations of amylase and lipase may or may not be clinically significant. These labs, if drawn, must be interpreted in context; and as Lisa states, “blanket” guidelines may results in unnecessary dose holds, or worse yet, unnecessary discontinuation.

            – Thanks for pointing out that colitis does not always mean diarrhea! This can be tricky for providers less experienced with the GI effects.

            Expert Nurse
            Avatar photoLisa Kottschade

              I had a chance to review these in a bit more detail since this last post. I do think once you get into the guidelines, the “guidance” offered is a bit more specific, however a bit cumbersome to follow. I think the one thing that I would say is maybe “lacking” is I would have liked to have seen a section on how to work up specific complaints. All of the pathways are after you have a diagnosis. For example, fatigue- would have been nice to have a “consider XYZ in the differential”. I’m curious what others thoughts are.

              Expert Nurse
              Avatar photoMollie Reed

                I agree with your statement, Krista…..there is certainly no one-size-fits-all approach to managing IMAEs. Some AEs definitely warrant longer courses of steroids than others. For example, rashes usually respond very quickly to steroids, and in my experience, wouldn’t warrant 6 weeks of steroids. And, you’re right on par with the endocrinopathies that don’t warrant interruption at all.

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