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We 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.
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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