February 14, 2018 at 4:05 pm #4687Expert Nurse
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?February 15, 2018 at 3:40 pm #4690Expert Nurse
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.February 17, 2018 at 5:21 pm #4696Expert Nurse
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.February 17, 2018 at 11:09 pm #4698Expert Nurse
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.February 21, 2018 at 5:22 pm #4706Expert Nurse
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.
LisaFebruary 23, 2018 at 5:53 pm #4713Expert Nurse
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.October 14, 2018 at 5:40 am #4904Expert Nurse
I have found the NCCN app very helpful when on the go, if I need to look up the irAE management guidelines. I work with one of the docs who authored the asco paper and we had a very rare late toxictiy evolve in a patient and I was able to pull up the guidelines in the the exam room onmy phone through the app to check the management strategy. The cool thing about the app too is that all of the guidelines have the most up to date version as the app is updated, so the most current info is at your finger tips.
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