[Virginia Seery]

This is a very relevant issue, especially in the adjuvant setting. This came up for us recently when a 34 year old woman with Stage IV melanoma resected to NED (no evidence of disease) was going to start adjuvant ipilimumab. She was recently married and asked about having children. In discussion with her PCP, she was referred to a fertility specialist who felt immunotherapy itself would not impact her ovarian reserve, but her advancing age could as she awaits completion of therapy and then more time to ensure she does not recur. For that reason, embryo cryopreservation could be considered. One of our concerns was that development of hypophysitis from I/O therapy may make in vitro fertilization difficult, but that was not felt to be a major concern as gonadroptropins would be used in this setting.

Here is another related question – what are your recommendations about pregnancy for females with a history of Stage III or Stage IV melanoma resected to NED?

[Virginia Seery]

Krista, my hesitation would be the need for chronic suppression with antivirals as this could potentially decrease the efficacy of T-VEC. However, if other options are limited or exhausted, it would be reasonable to consider with close monitoring for recurrent ocular symptoms.

[Virginia Seery]

Great question Lisa! Our approach to this issue follows Krista’s guidelines with each particular patient’s situation evaluated independently weighing the risks and benefits. Several years ago we would have avoided I/O therapy in patients with autoimmune conditions, but that practice has now changed as more information has come out showing that it can be offered to some patients.

[Virginia Seery]

In our hospital, pharmacy thaws and draws up the specified amount of T-VEC into syringes for each individual lesion. This is very helpful during the injection so you do not have to control the amount injected into each lesion.

[Virginia Seery]

We do not routinely give premedication for ICI’s. If a patient develops an infusion reaction, they will receive premedication thereafter.

[Virginia Seery]

I have not seen any ocular herpes and we have been doing T-VEC routinely for about two years. I have had two patients develop occasional canker sores during therapy, but both of them had a history of this before starting T-VEC.

[Virginia Seery]

Thank you Kathleen and Lisa for your feedback.
Kathleen, we are going to start maintenance dosing with infliximab which is a great suggestion. Lisa, I had not thought about approaching the company for assistance. I will look into that. We have sent stool for C diff, shigella, salmonella and camplyobacter all of which were negative. Interestingly, she is now being treated for serratia bacteremia with cipro so it will interesting to see if that helps.

[Virginia Seery]

Hi everyone,
I am wondering if anyone has a suggestion for ipilimumab (10 mg/kg dose) induced ileitis/colitis that has been refractory to both oral and IV steroids as well as three doses of infliximab. We have been treating her since May on steroids for this issue. We wanted to give vedolizumab as there are some reports of this being used in these cases, but her insurance company will not pay for it (despite a peer to peer review and referenced articles). We have consulted the GI team, but they do not have any other suggestions. We are planning to give another dose of infliximab, but if anyone has a different suggestion, I would welcome it!

Best,
Virginia

[Virginia Seery]

I do not recall seeing that, but will pay more attention to concomitant meds with our patients on BRAF/MEK inhibitors.

[Virginia Seery]

Lisa,
Great topic. We ask our patients on systemic therapy to avoid herbal medications, particularly antioxidants, as there is concern they may decrease the efficacy of treatment. Being on multiple meds (prescribed, OTC and herbals) makes it more difficult to sort out the source of side effects when they occur. This is definitely an area where more research is needed given the number of people on alternative meds.

[Virginia Seery]

I have not had increased reports of vivid dreams while on ICI’s, but perhaps this is a milder form of neurotoxicity (reported in 1-3% of patients on these agents)?? As you note, this is very common with high dose IL-2 and can worsen if therapy is not held. Anyone else have ICI patients reporting vivid dreams?

[Virginia Seery]

Hi Lisa,
Krista Rubin gave an excellent overview of targeted therapy in the adjuvant setting (from the COMBI-AD Phase 3 trial) in the immunotherapy section above. In terms of practice change, this would call for BRAF testing in all Stage III patients which is not necessarily the standard approach for all practices. This is a very exciting time in melanoma!

[Virginia Seery]

Krista,
This is an excellent point. It is difficult to watch patients and families struggle with the financial concerns of cancer therapy when they have such a bigger battle to wage against their disease. I have had good experiences with the drug companies’ financial assistance programs, but the process takes time and resources to make it happen.

[Author]

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