[Krista Rubin]

Virginia and group-

Would love your thoughts. We had a patient s/p TVEC injection whom required admission about 5 days post injection for an unrelated issue. Assuming the injection site remains covered with an occlusive dressing, would that patient need to be on contact precautions while in house? Or are standard precautions enough?

Thank you!

[Krista Rubin]

That is a great idea Kathy, to have the rep provide an in-service to the housekeeping team. They too are teammembers and providing dedicated education for them as well is a wonderful teambuilding approach. Thanks for that info!

[Krista Rubin]

Great info Kathy!!

Glad you mentioned the cholystyramine. We too will use this to bulk the stools and it is very effective.

[Krista Rubin]

HI Kathy-
Great question. When we first began to treat numerous patients with immune checkpoint inhibitors, we found out quickly that it was ideal to have a “go to” person in subspecialty practices. Notably, GI and dermatology were identified as the greatest need at the time (this was going back about 10 years now when ipilimumab was in clinical trials). Honestly, many of the relationships we now have, stemmed from fellows being “assigned” to these patients. I would often have a conversation with these individuals describing these therapies and the need to have a “go to”. Many were very intrigued by the science behind the toxicity and from there, interest and curiosity blossomed. Eventually with use of ICIs by other cancer disease groups and more and more patients were experiencing toxicity, these other groups reached out to us (the Melanoma Team) for our contacts.

Over time, we had established a contact within multiple subspecialties and developed a “List” – this eventually turned into what is now an established “Immunotherapy Severe Toxicity Team”. Often, one of the physicians would reach out to a department head, explain the need for an established contact along with the rationale. This approach,for us, was incredibly helpful.

Regarding your second question- for the most part, if we have a patient with underlying autoimmune issue- depending on what it is, we may or may not reach out. For example, for someone with underlying hypothyroidism, we “take over” the management of TFTs an replacement dosing. I make a point of noting this in the patient progress note and ensure a copy is sent to the patients provider. If it is a case of underlying UC or Crohn’s- then YES, we typically do reach out with the intended plan to co-manage these patients. Ideally, co-management is the best approach, but not always feasible.

Thanks for posting.

PS- I would add one more thing. For community practices, I believe proactive identification of subspecialty providers in the community is CRITICAL to successful outcomes for patients receiving ICIs.

[Krista Rubin]

Virginia’s comment made me think about this question: How many others are using vedolizumab for infliximab refractory colitis?

[Krista Rubin]

I reached out to Dr. Michael Dougan. He is a GI physician and is a MAJOR member of our Severe Immunotherapy Toxicity Team at MGH. Here is his response to the question about probiotics.

“The current evidence in insufficient to support a recommendation for or against probiotic treatment during immunotherapy. Based on animal models, it is likely that the microbiome (the population of bacteria living in our gut) has an influence on the outcome of immunotherapy. However, at present we do not have enough information to know if the bacteria in probiotics will improve the antitumor response, or change the risk for developing diarrhea or colitis with ipilimumab or the PD-1/PD-L1 blocking antibodies. This is an ongoing area of active research and we will begin to have answers to this question in the near future. In the meantime, I recommend that providers not take a strong stand on this issue, but they can reassure their patients that it is unlikely that probiotics would be harmful”.

Michael Dougan, MD PhD
Assistant Professor of Medicine
Division of Gastroenterology
Massachusetts General Hospital

[Krista Rubin]

Thanks very much for the info Kathy and Virginia. I will share your comments with the appropriate folks in the billing arena.

[Krista Rubin]

This is a very timely question. As a consequence of the release of the practice changing adjuvant therapy data surrounding nivolumab, the volume in our practice has dramatically increased in the past few months. This in turn leads to a busier infusion/treatment center.

We have been administering ipi over 30 minutes (the 3mg/kg dose) for over a year. We have not seen any increase in infusion reactions.

We have NOT yet switched to nivo over 30 minutes, however, we are hoping to do so very soon. This is based on a fair amount of published literature demonstrating safety for both ipi + nivo over 30 minutes. I do believe 30 minutes will soon be the “standard” for both ipi + nivo very very soon.

Would love to hear what others are doing in their practices.

[Krista Rubin]

Yes- I do have a number of patients ask; and because of that, I posed it to our GI physician whom is part of our immune toxicity team. Please do not quote me on this until I can get more of a definitive repose, but for now, he tells me that there is very little data supporting its use in prevention of ICI associated colitis.

The GUT microenvironment is a hot topic right now- so I suspect there will be more published data in the near future. In the meantime, I will see if I can get more of a data supported answer to this question; it is a good one!

[Krista Rubin]

HI Lisa- you ask an excellent question.

– Shingrix is non-live, recombinant vaccine just recently approved for prevention of zoster.
– Zostavax is a live, attenuated vaccine approved for prevention of zoster.

Given the recommendation to avoid live vaccines while on immunotherapy, Shingrix would be the better of the two choices. Agreed- we do not have data regarding safety of use in the setting of immune therapy, specifically immune checkpoint inhibitors, but theoretically…..

This may be an ideal option for patients at risk; and importantly, prevention of zoster prevents associated post-herpetic neuralgia—this is debilitating for some individuals.

Thanks for posing this question Lisa.

[Krista Rubin]

Funny you should bring that up Virginia. We have seen similar scenarios where patients with ocular melanoma, if anything, are having stabilization of their disease and this seems to be ongoing. Unfortunately the majority of those patients (in my experience) do ultimately progress, but when combined with other liver directed therapies, (such as SIRT, etc) some do fairly well. I agree that it is better than I would have expected. I have not seen as beneficial results with vaginal melanomas. I’m not sure you’re experience has been.

[Krista Rubin]

So- I had success with a daily cetirizine. It is possible she may have had a mild URI, or similar- but she experienced it both on dabrafenib + trametinib AND vem/cobi (which we needed to switch to for unrelated reasons).

Thank you for your reply Virginia I’ll let you know for get any more!

[Krista Rubin]

These cases can be so challenging. Agree with Lisa in that imaging is warranted primarily given his reports of imbalance; we too see lots of radiation necrosis and this can cause significant symptoms for patients.
Reports of lightheadedness can be anything from dehydration, to need for anti-HTN med adjustments, etc., and I would be less worried if it were just that…but the imbalance is concerning.

Thanks for sharing!

[Krista Rubin]

Hi Lisa-
We had very few patients on adjuvant ipi due to the high risk of toxicity. The few we did have on, had completed the 4 doses.

Had we had any patients- I have to say our actions would mimic Virginia’s.

[Krista Rubin]

I would say that in my practice, about 1/4 of patients will be dose reduced. For the majority, it is related to the pyrexia!! I find this toxicity to be very challenging. I have yet to see a patient on dabrafenib + trametinib that does NOT develop pyrexia. It is very unpredictable who tolerates it and who does not. I have a patient right now that is 6 weeks into therapy (for metastatic disease) and breezed through the 1st 6 weeks, then bamm- she got hit with fever to 101F, chills, malaise. Both meds are on hold, and despite acetaminophen and ibuprofen (alternating) throughout the day, she has yet to break the fever. It has been waxing and waning from 99-100.9 OFF meds. I am giving her through the weekend, and if she is still febrile, will initiate low dose prednisone.
She is a patient whom I will restart (once afebrile for 24 hours) at 50% dabrafenib, but full dose trametinib. If she tolerates it, I would then escalate back to full dose dabrafenib after about 5 days.
She may also require prednisone to be added to the regimen.

These pyrexia events can be quite challenging!

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