Similar trials must eventually be conducted with patients who have locally advanced resectable squamous cell carcinoma before altering the standard of care.
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April 2023“One of my concerns is that neoadjuvant immunotherapy could become a bit like the Wild West, with folks trying different things because they want to help patients,” Dr. Gross said. “That’s one of the reasons why I’m committed to developing a phase 3 trial.”
Is neoadjuvant immunotherapy a safe option for immune-suppressed patients with advanced cutaneous squamous cell carcinoma? Because immunotherapy revs up the immune system, immunosuppressed patients (including those who have undergone solid organ transplantation and are taking medication to ward off organ rejection and those who have autoimmune diseases) have traditionally been excluded from immunotherapy trials.
“We may find that there’s a group of those patients who should be considered for neoadjuvant immunotherapy,” Dr. Divi said. “For example, some of them may be able to tolerate the drugs without a significant flare of their autoimmune disease and may have a positive response.”
Additional research is needed to determine which immunosuppressed patients may be candidates for neoadjuvant immunotherapy and what doses are safest and most effective.
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Although more work needs to be done to determine precisely how and when to offer neoadjuvant immunotherapy for the greatest advantage, the availability and largely positive outcomes of this novel approach to advanced resectable cutaneous squamous cell carcinoma means that physicians who see these patients should pause before launching into the traditional standard of care.
“Our previous instinct of ‘surgery first’ should now be, ‘Does this patient need surgery first, or do we need neoadjuvant therapy first?’” Dr. Emerick said.
The answer to that question, of course, is not always clear. “Not every patient is a good candidate for receiving neoadjuvant therapy first,” Dr. Divi said. “If a tumor is borderline resectable, that’s a challenge, because if we get a big shrinkage with neoadjuvant immunotherapy, that’s a huge win. However, if we don’t get that shrinkage and it grows instead, we can go from a resectable tumor to an unresectable one.”
Despite the risk of tumor advancement, Dr. Gross said it’s reasonable to try neoadjuvant therapy before surgery if surgical treatment will likely damage function. “If you’re contemplating removing someone’s eye, ear, or nose to remove this cancer, there may be a better option,” he said. “Even without a phase 3 trial, I think neoadjuvant immunotherapy should be considered for patients who have disease that’s encroaching on critical structures.”