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Neoadjuvant Cemiplimab-rwlc and Surgery for Skin Cancer Subtype: Follow-up Trial Data

By: Joshua D. Madera, MD
Posted: Monday, April 8, 2024

For patients with locoregionally advanced cutaneous squamous cell carcinoma, the neoadjuvant use of the monoclonal antibody cemiplimab-rwlc and curative-intent surgery may improve long-term clinical outcomes, according to follow-up data from a multicenter phase II trial published in The Lancet Oncology. However, additional investigative efforts are needed before implementing this combined treatment approach as the new standard of care in this patient population, explained Neil D. Gross, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues.

“The primary analysis of this study demonstrated a high rate of pathologic complete response (51%) among patients with resectable cutaneous squamous cell carcinoma who received neoadjuvant cemiplimab,” the authors noted.

From 2020 to 2021, a total of 79 patients with resectable cutaneous squamous cell carcinoma were recruited for the study. All were given a maximum of four doses of cemiplimab before receiving curative-intent surgery (n = 70). After surgical intervention, they were observed (n = 32) or administered adjuvant cemiplimab (n = 16) or radiotherapy (n = 17) per investigator discretion.

At data cutoff (December 2022), the median follow-up was 18.7 months. The study authors reported event-free survival events in 14% of patients. The estimated 12-month event-free survival rate was 89%. In addition, there was no evidence of recurrence in any patient of the 40 patients who had previously achieved a pathologic complete response. One episode of recurrence was documented in one patient who achieved a major pathologic response. Furthermore, disease-free survival events were documented in 9% of patients who underwent surgery. Moreover, the use of adjuvant cemiplimab led to treatment-related adverse events in 25% of patients. These events included hyperkalemia, traumatic limb amputation, cardiomyopathy, and hypophysitis.

Disclosure: For full disclosures of the study authors, visit thelancet.com.


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