Patient Follow-Up After Receiving Cemiplimab

Gregory A. Daniels, MD:The studies looked at either 1-year exposure or 2-year exposure to the medication for patients with advanced cutaneous squamous cell or metastatic cutaneous squamous cell who received cemiplimab. We have follow-up for just shy of a year in these patients looking at the responses maintained. The guidelines that were done in the clinical trial were as long as the patient was tolerating and maintaining response, that they continued again for either 1 or 2 years.

Now that we have access to the medication, the label recommends that we continue this medication for as long as the patient is tolerating it, or there’s a clinical response. This is an area that really needs further study. I’d say that, for example, in melanoma where we use these checkpoint pathways much more commonly, we’re still struggling with the idea of how long do we keep patients on? What is some of the monitoring that we need to do later on? Can we stop the medication? These are ongoing questions with cemiplimab and cutaneous squamous cell cancer.

As far as toxicity management or monitoring goes, at each dosing there are standard blood tests that are recommended such as thyroid monitoring every 6 weeks or so during infusions. As we all know now, these toxicities can occur months after starting or even stopping the medication. So, they still need to be involved in their healthcare team.

I also think it’s important to bring in all the support that the patient has such as their primary care doctor and/or their dermatologist; they should all be aware. In fact, at our institution we’ve implemented a banner system on the electronic medical record if the patient is on these medications, such as cemiplimab, for this indication. If they hit the emergency department or another healthcare environment within our system, a popup window will alert the provider that this patient is on this particular medication.

For that patient who either doesn’t get a response with cemiplimab, or experiences a response and then progresses, that’s an opportunity to go back to the multidisciplinary tumor board and have a discussion again. For example, sometimes a patient may have a response that makes surgery or radiation an appropriate modality again, so I’d consider that. Going back to the tumor board, we also have clinical trials that we can look at for newer agents or combinations of agents in this indication.

Transcript edited for clarity.

Case: A 79-Year-Old Male With Metastatic CSCC

April 2016

• A 79-year-old male presented to dermatologist with a large ulcerative lesion on clavicle; he reported lesion first appeared 5 months ago while living in Florida for the winter
• Diagnosed with localized cutaneous squamous cell carcinoma
• Standard surgical excision performed with 4 mm clinical margins; postoperative margins negative

May 2018

• Patient returns to dermatologist for follow-up c/o multiple lesions on shoulder and neck around the site of prior excision
• PE:
  • Multiple visible, ulcerated lesions, approximately 2-3cm in diameter; suspected tumor depth >5mm
  • Multiple palpable nodes ~2cm
• Imaging confirmed 7 mm invasion into subcutaneous fat; parotid nodal involvement
• Biopsy confirmed cutaneous squamous cell carcinoma, poorly-differentiated
• Diagnosis: Metastatic cutaneous squamous cell carcinoma
• Stage IV: T3N2M0
• Patient started on cemiplimab