[Virginia Seery]

We have not seen a change in the side effect profile on 480 mg vs 240 mg dosing in the adjuvant or metastatic setting so far which surprised me a bit. What about others?

[Virginia Seery]

Excellent point, Lisa. We have been trying to sort out how best to accomplish this at our institution. Prior to the adjuvant approval, we had obtained BRAF testing on patients with a high risk of recurrence (i.e. Stage IIC/IIIB/IIIC). Our practice will now be changing to include any Stage III patient. As previously noted, I/O therapy would be preferred, but targeted therapy is an alternative to observation for those with autoimmune conditions. The need for an FDA approved test complicates the situation as our in house test has a fast turn around time, but will not be enough to justify starting adjuvant therapy. So this is a work in progress for us! If anyone has a good system, please pass along!

Virginia

[Virginia Seery]

Surprisingly, we have not had many patients asking us about this trial. I know going into it there was a lot of excitement about the combination so we were surprised it did not reach its endpoint.

[Virginia Seery]

We premedicate with acetaminophen and/or ibuprofen prior to TVEC if not contraindicated. I recommend the patient continue this for the first 24-48 hours if feeling flu-like. I think it helps based on patient reports of how they feel when they forget to take it. There also seems to be great variability in degree of side effects among patients. Anecdotally, I have seen fewer side effects in elderly patients (similar to ICI’s), presumably due to a less robust immune system. If a patient has nausea, I will also premedicate with antiemetics.

[Virginia Seery]

I have not seen that either, but agree with Krista that it sounds nerve related. Keep us posted on him.

[Virginia Seery]

Surprisingly, we have not had recent difficulties getting PET/CT scans paid for in our melanoma population. However, I worry that some of our patients have a large copay for these scans. Yesterday, I had a Stage III high risk patient miss his appt; when I called him, I learned he also missed his PET/CT because of the high copay for the scan. We often interchange PET/CT with torso CT unless the area of concern is on an extremity.

[Virginia Seery]

All good points.

We have decided to transition some of our reliable, long term patients to every 4 weeks. For complicated patients with multiple issues, we will keep them on every two weeks. New patients are starting on the 2 week schedule and if doing well after 2-3 cycles, we will consider changing to every 4 weeks. We have not yet seen any infusion reactions thus far.

[Virginia Seery]

Lisa,
I have not seen severe hypercalcemia on the ipi/nivo combination. A calcium of 18 is certainly not subtle; I hope your patient does OK. Anyone else?

[Virginia Seery]

Our institution has a template that we use for survivorship care plans. We are alerted by someone from our Health Information Management Dept. that the patient needs one before they come in and a template is included with some of the patient’s specific information which saves some time. Providers review and edit the document for accuracy and fill in any blanks. This process is helpful.

I agree with Suzanne about the awkwardness of completing one of these for a patient who has been free of disease for some time. Also, the term “survivor” is not appreciated by all of our patients.

[Virginia Seery]

Krista,
Great questions and very relevant right now with increased adjuvant options. Unfortunately, I am not well versed in this topic, but I will share what I know.

I believe that it will depend on a patient’s insurance whether the cost of fertility counseling is covered. I recently had a patient in this situation; the cost of counseling was covered, but not the fertility preservation (egg harvesting or IVF). And it is incredibly expensive (one patient told me $10-20,000).

We have referred patients to a nearby IVF center for counseling. However, it would be really helpful to identify a resource within the institution.

The idea of asking Pharma about their experiences is a good one. It sounds like we should contact our reps and inquire about post marketing data. We have to start somewhere to learn about this very important issue!

[Virginia Seery]

Krista,
I spoke with our BMS rep about the potential higher incidence of infusion reactions at the 480 mg dose and was told it was not felt to be an issue. It will be interesting to see what the formal data shows as well.

[Virginia Seery]

Hi Lisa,
Thanks for letting us know about the Medicare restrictions on dose of nivo. I was unaware of that. We just started our first patients on 480 mg this week – all went well.

Krista, excellent point about not seeing patients for 4 weeks. We had been seeing nivo patients in clinic every 4 weeks after 2-3 cycles of every two weeks if things were going well. They would come in for the nivo infusion with a treatment nurse at the 2 week point, but no formal appt. with an MD or NP. If any AE issues were noted by our nurses, then the patient would be seen by an MD/NP. The new schedule takes away that interim 2 week appt. so we will have to reassess our communication practices. Maybe a phone call to those patients at the two week time point should be instituted.

Let us know your experiences with this practice change.

Virginia

[Virginia Seery]

We are finally making this change in infusion time for nivo. How do you think the new 4-week nivolumab dosing will impact treatment choice for anti-PD-1 inhibitors? This will certainly help decrease the high volume somewhat in our infusion center.

[Virginia Seery]

I hate to say it, but we tend to start the combination that we are most familiar with – dabrafenib/trametinib. However, if someone develops side effects, we certainly think about vem/cobi.
Factors that would sway me to switch would be a better side effect profile and improved efficacy. It looks like the data for encorafenib and binimetinib will meet those qualifications so it is very exciting.

I suspect a third combination will help bring down the costs of these meds as they each look to protect or gain their market share. What a whirlwind for new drug approvals in melanoma! It is exciting and challenging all at the same time.

[Virginia Seery]

Hi Lisa,
Thus far, we have not been offering nivolumab to Stage IIIA patients since the trials have not included that population. However, I hope this can be revisited in the future and I would be very interested in what others are doing at their institutions.

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