Next Steps in the Treatment of cSCC

Anna C. Pavlick, DO:How do you follow patients? I think the rule of thumb while your patient is on therapy is that the patients are seen and labs are done every single time the patient is treated. When there’s a decision to take patients off therapy either because they’ve had a complete response or they’ve developed unacceptable toxicity, you just decide you’ve maximized the benefit, and it’s time to be taken off the drug.

These patients, at least for me, get seen every 3 months. If they’ve had metastatic disease, they get imaged every 3 months for the first year off therapy. Once I’m convinced that they have stable disease after a year, they get imaged every 4 months for the second year. After that, they usually get imaged twice a year for year 3, because we know that once they achieve that durability—usually after 2 to 3 years—I become more comfortable in thinking that patients are going to remain either disease-free or with stable disease, so I don’t have to follow so closely.

I still see them in the office every 3 months in order to assess that they don’t have anything else going on. But, again, this is a new horizon for us. We’ve never had anything that’s been this effective. We now have to start making up the rules for how we follow this patient, what do we do, and what we look for. We don’t know. We’re writing it now, and hopefully within the next year we’ll be able to provide doctors throughout the world with guidelines as to recommendations on how to follow these patients and how to manage them both on and off therapy.

A 50% response rate doesn’t equal a 100% response rate. Not every patient is going to respond to cemiplimab. I think the patient’s situation depends on what you do next. If the patient has some response, that would then render them surgically resectable. If this was something that was locally advanced, you might decide instead of having a life-threatening or life-disfiguring surgery, it might be easier to see if we can get this tumor to shrink up and then send the patient to the OR [operating room] for salvage. I have done that so I get some response, but not enough of a response. The patients stop responding, and I just want this tumor removed. The patient can now successfully go to the OR with a less invasive and disfiguring surgery.

If the patient has metastatic disease and doesn’t respond to cemiplimab, I’m not a big advocate of undergoing second-line chemotherapy, because we know that there’s no durability and response rates are low. I advocate that they participate in a clinical trial.

There are a number of different trials that are looking at combining different strategies of immunotherapy—taking the base that we have with anti—PD-1 [programmed cell death protein 1] therapy and combining it with another immunotherapy. There are also going to be some trials that are going to be looking at taking immunotherapy and using tumor-directed therapy, in which you either inject or treat the lesion with a topical or an injectable immunotherapy.

I think we’re still leaning down that immunotherapy road, as to how we take that 50% and make the 50% the 100%. We’re just building on the PD-1 story and trying to make that better.

Transcript edited for clarity.

Case: A 74-Year-Old Male With Recurrent Metastatic CSCC

November 2017

• A 74-year-old male from Florida, with history of multiple resections of CSCC on neck, back and shoulders presents with new deep lesion that exhibited perineural invasion and c/o palpable left axillary mass
• Imaging confirmed 6cm left axillary nodal conglomerate
• Patient treated with neoadjuvant cisplatin/5FU for 3 cycles
• Surgical resection of primary lesion; Lymphadenectomy revealed CSCC involvement in 12 out of 16 resected lymph nodes

May 2018

• Follow-up scans revealed early disease progression with multiple pulmonary nodules
• Patient started on carboplatin/paclitaxel for 3 cycles

November 2018

• Repeat imaging showed disease progression in pulmonary nodules and multiple lymphadenopathies; mediastinal, left and right axillary; bone metastases
• Patient started on cemiplimab for 3 cycles

February 2019

• Reimaging PET-CT revealed reduction in size and metabolic activity of right and left axillary, and mediastinal lymphadenopathies; pulmonary nodules had considerable reduction in size and were no longer substantial