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Cutaneous squamous cell carcinoma (cSCC) appears to far outweigh melanoma as a cause of death from skin cancer. Each year, more than 15,000 people in the United States die from cSCC, more than double the number of melanoma-related deaths.1
This worrying statistic has caught the attention of industry and researchers, who are developing new ways to assess squamous cell carcinoma risk and to better treat the disease.
INDIVIDUALIZED RISK ASSESSMENT BY PROFILING GENE EXPRESSION
Cancer staging systems for squamous cell carcinoma, including those from the American Joint Committee on Cancer and Brigham and Women’s Hospital, have helped improve the ability of dermatologists to accurately stage cancer, according to Sherrif F. Ibrahim, MD, PhD, associate professor of dermatology at the University of Rochester Medical Center in New York and spokesperson for the Skin Cancer Foundation. “However, when we stage cancers, it doesn’t really help the individual. This tells us that if you take everyone at some point [of] squamous cell carcinoma, they have a certain chance of having a bad result, ”Ibrahim said.
A new type of test could be more useful for individual patients, according to Ibrahim. In September 2020, the (FDA) approved a new custom gene expression profile assay indicated for use in squamous cell carcinoma, DecisionDx-SCC (Castle Biosciences).
“Using this test, we can actually study the individual genes in a given patient’s squamous cell carcinoma and determine their risk for metastasis,” Ibrahim said. “What we’re hoping for is… to approach staging on an individualized level, not just in an individual patient, but even for an individual cancer in a patient who has multiple cancers. And we can determine which of those patients might require closer monitoring, closer follow-up, more imaging, and possibly additional treatments later.
Castle Biosciences has a similar test approved for melanoma. “Individualized risk assessment through gene expression profiling is an exciting development, but of course there is still work to be done to determine how these tests will be integrated into our day-to-day management of these diseases,” Ibrahim said. .
Skin cancer care is evolving towards more accurate risk assessment coupled with more personalized treatment. This will be particularly valuable in the context of cSCC, Ibrahim said: “We do not have good guidelines on how often patients should be photographed, what type of imaging to use and what type of adjuvant therapy would benefit the patient. more to high-risk squamous cell carcinoma. the patients. But with these individualized genetic testing, we might be able to really start probing these questions to develop more structured guidelines for the management of more advanced cases, of which we’re seeing a lot more.
NEW AND EMERGING THERAPIES OF SBCC AND BASAL CELL CANCER
The FDA has approved 2 checkpoint inhibitors, cemiplimab (Libtayo; Regeneron Pharmaceuticals) and pembrolizumab (Keytruda; Merck), for locally advanced or metastatic squamous cell carcinoma. Pembrolizumab received OK for the treatment of recurrent or metastatic cSCC in June 2020.1 The FDA approved cemiplimab in September 2018 for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or curative radiation therapy.2
“A lot of people don’t realize that there are these new and emerging therapies,” Ibrahim said. “We have seen great progress for locally advanced non-melanoma skin cancer, including the Hedgehog inhibitors vismodegib and sonidegib for basal cell carcinoma.
Treatment of sporadic, small, melanoma-free skin cancers is also advancing, including many injectable and topical agents, according to Ibrahim. “For example, we have an ongoing trial with Regeneron looking at intralesional immune checkpoint inhibitor therapy. It includes injectable therapy for small squamous cell carcinomas of 1 to 2 cm. The hope is that we will have great results without [adverse] effect profile of the systemic administration of these drugs, ”he said.
Ibrahim is one of the researchers studying an experimental viral-mediated interferon. Interferon works well for basal cell cancers when injected, but the painful 4 or 5 injections required per week for several weeks are prohibitive. Stamford Pharmaceuticals’ new agent, a slow-release injectable interferon, only requires one injection per week for 3 weeks. “We expect to achieve a clearance of over 90% for sporadic basal cell cancers using this therapy,” Ibrahim said.
A topical hedgehog inhibitor, patidegib, has advanced further down the pipeline and is in Phase 2 trials. When administered systemically, Hedgehog inhibitors have a high adverse reaction (AE) profile. The hope is that this topical agent from PellePharm may help patients with or at risk for basal cell carcinoma with fewer AEs.
Intralesional treatments for ordinary small skin cancers will provide a much-needed non-surgical treatment option, Ibrahim said. “This is an exciting and rapidly changing time in the field of skin cancer,” he said. “With many new advancements in understanding the genetic basis of the disease and better non-surgical options for treating all tumor severities, we hope to bring better outcomes to our patients.”
Disclosure:
Ibrahim is an advisor, speaker and investigator for Castle Biosciences, Genentech and Regeneron; an advisor and lecturer for SUN Pharmaceuticals and an advisor and investigator for Stamford Pharmaceuticals.
The references:
1. Skin cancer facts and statistics. Updated April 2020. Accessed January
ary 8, 2021. The Skin Cancer Foundation. https://www.skincancer.org/ skin-cancer-information / skin-cancer-facts /
2. The FDA approves pembrolizumab for cutaneous squamous cell carcinoma. US Food and Drug Administration. June 24, 2020. Accessed January 8, 2021. https://www.fda.gov/drugs/drug-approvals-and-databases/ fda-approves-pembrolizumab-cutaneous-squamous-cell-carcinoma
3. The FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma. US Food and Drug Administration. January 18, 2019. Accessed January 8, 2021. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-cemiplimab-rwlc-metastatic-or-locally-advanced-cutaneous-squamous – cell-carcinoma
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