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HI Lisa,
Despite the rampid impact of flu among staff, patients and community we have only had a modest inquiry from patients on ICI’s regarding taking prophylatic tamiflu. Our approach is congruent with that of yours, if at high risk, in a high risk situation (direct care provider for an flu + ill person), or demonstrating early onset sx then we typically are not recommending tamiflu.Homeopathic approach:
Oscillococinium, 1 vial weekly during flu season, may serve as a respiratory protectant against respiratory aquired illnesses. This can be used in addition to regular good sleep, eating, hydration & stress management habits.
This is not a guarantee just as tamiflu is not a guarantee of not acquiring the flu, but it may reduce risk and will not interfere with other medications.
Oscillo can be found OTC at most pharmacies where homeopathic medications are available.HI Yael,
ICI related hepatotoxicity can be challenging, factors that make it difficult to treat can be an activation of a hepatitis viral infection, a high burden of liver metastases and insuring that there are no obstructions. The liver biopsy that your patient had may be helpful to determine how her liver cells are behaving, especially if therapeutic interventions are not demonstrating effectiveness.
Early on in clinical trials and with challenging cases such as yours, the biopsies often resulted in proliferative lymphocytic activity. Mycophenolate can be useful given by intravenous vs orally concomitantly with continued high dose steroids 2mg/kg. If a patient seems to not be as responsive to methyprednisolone IV, considering a switch to dexamethasone IV ( if not already on dex). These cases can be very tough, most of my patients recovered, but it was a slow and long process that can take up to 8 + weeks.I am confident that my other colleagues here will have some additional advice or pearls to offer.
The very best to your patient, and if you have any additional inquiries or discussion points, we welcome the continued conversation.Regards,
KathyWe really haven’t used it in the adjuvant setting as of yet. We are treating patients mainly either in a adjuvant clinical trial or with Nivolumab. What I found intersting in the adjuvant BRAF study is was there was a higher incidence of pyrexia compared to the metastatic studies. The Pyrexia can really affect patients quality of life which makes it difficult to justify in the adjuvant setting.
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.
Currently Nivolumab is approved for 30 min infusion for all melanoma metastic indications as single agent or in combination with Ipilimumab. However, the adjuvant Nivolumab was approved after the 30 min Nivolumab had been submitted to the FDA. Therefore for adjuvant Nivolumab the label states that it should be given over 60 min. There should be an update to the label soon, and adjuvant Nivolumab will be approved for 30 min infusion. There are several studies to support it’s safety in infusing it over 30 min.
LCDs can vary state by state. As Kathy mentioned the New York LCD for Medicare was recently changed. However other states may have different icd 10 codes approved for infliximab. Therefore you should check your states LCD to determine the icd 10 codes that are covered. These are available on the internet if you google the drug name and LCD alone with state you are located in.
The flipped dose clinical trials allow for the Ipillimumab 1mg/kg to be given over 60 min. We have started to do more flipped dozing of Nivolumab 3mg/kg and Ipi 1mg/kg which we are seeing less toxicity with but what appears to be the same response rates to the FDA approved dosing.
Baseline before or onset of therapy EKG & echo (if pt had a recent one with in several months- will obtain that info) if no echo on file- will send pt for baseline echo, but would not delay start of therapy
2 weeks after start of therapy- EKG
1 month after start of therapy- EKG
2 months after start of therapy- Ekg & Echo if any susupicous sx, prior EKG changes or extensive cardiac history
Typically if a patient is doing well we will then perform an EKG every 12 weeks in cadence with scans
Echo q 6- 12 monthsNovember we had 2 new patients revieving TVEC, we had our TVEC reps come in and inservice our housekeeping team as the handling guidelines were updated to reflect a less toxic, less expensive alcohol based cleaner for pharmacy prep & administration room cleaning.
We do still isolate a room and close it until it is cleaned & we do have disposable curtains in that room to stream line the process- we keep one room on our exam room floor prepared with the disposable curtain for any infectiuos issues or for these treatment patients.
PPE: we still gown, glove and wear mask with protective eye shield. All potentially soiled materials are disposed of in red bag waste.
The visit & education session was very helpful from our local rep.Ipi 3mg/kg is still approved for 90 min infusion, however, the FDA just recently approved the nivo in the metastatic setting to be admin over 30 min.
Is anyone using flip dose ipi/nivo?
We had a 2 problems this past week (Jan- Feb) achieving a stream line auth for infliximab for 2 pts with grade 4 colitis, steroid refractory. One of our MD’s meet with our financial team & administration.
What emerged from that meeting was the following update & practice suggestion:The LCD for Medicare was updated 11/1/17 to reflect approval for infliximab
-using the ICD-10 code “K52.1-Toxic Gastroenteritis and Colitis”. For those patients who do not respond promptly (within 72-96 hours) to therapy with high-dose corticosteroids, Infliximab 5mg/kg may be utilized according to NCCN and ESMO guidelines, and soon ASCO guidelines. It has been included in the BMS algorithms for a decade.
To overcome issues with getting infliximab approved urgently for patients with ICI related diarrhea/ colitis and ensure that the financial team has all appropriate clinical information to obtain insurance authorization, the following is suggestedClearly document a diagnosis of ICD-10 Code “K52.1-Toxic Gastroenteritis and Colitis” in the following places:
· Progress note for the related encounter
· Problem List
· Diagnosis used for professional billing when you close the encounterI hope this update will be helpful to all & we will keep you posted with any barriers that we encounter- if any!
Thank you so much Krista for the expert GI MD weigh on this topic. I am usually cautious about recommeding adding probiotics when some one is in full grade 4 liquid diarreha. Our rationale is that with the acute inflammation, there are many microscopic openings placing a patient at risk for infection & coupled with the lack of being able to absorb and process medications normally in the gut. Tytpically if our practice adds a probiotic will be when the stools are soft and leaning more toward some form, bland proteins are being better tolerated while on a steroid taper. A slow recovery can also be aided by cholystyramine ( Questran) powder 1-3 x daily to help bulk the stool.
Hi Krista,
This has been an ongoing issue for quite some time now. In my experience the greatest chances of success are coding the ICI related diarrhea as ulcerative colitis ( K51.00-51.8- these codes encompass variations on UC + complications), clinical documentation has to reflect the accompanying diagnosis code.
The greatest issue that we encounter are the delays in approval, that a PA may take several days, so if we suspect that a diarrhea situation may be headed toward needing infliximab, we start the auth process in the out pt setting. Sometimes the coding can be an issue and complicate the process if a coder submits the wrong code, based on their interpretation of the clinical information.
If a patient is referred to our ER for immunotherapy induced diarrhea that is refractory to steroids, we have been successful in patients receiving infliximab in the ER.
In patient, we have not experienced the third party payer issues in quite some time, as the patients are correctly diagnosed and coded upon being admitted for ulcerative colitis.I agree with the aforementioned possibilities & considerations. Although, it is a little early for radiation necrosis onset, which usually presents 6-12 months post radiation- but it should still be part of the differential considerations.
Additionally, if a brain MRI reveals no new masses, these symptoms could be related to an early paraneoplastic leptomeningeal disease presentation. While this is uncommon, it often presents with persistent symptoms despite clean imaging. Dexamethasone to manage the symptoms & as long as the patient symptoms are under control, continuation of ICI therapy could be an appropriate course of management. These can be such tough cases, good luck with your patient and thank you for sharing. Looking forward to an update on how he is doing.There was an interesting article published in cell metabolism this month that talks about low carb diets and melanoma. It says the opposite of what most patients think. That a high fat low carb diet may not be the best for melanoma patients. The article states that patients with a BRAF V600E mutation may have there cancers grow faster with a high protein diet. The study was done in mice, so need more research just like many of the food studies out there.
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