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Soo Park, MD
Soo Park, MD
Posted: Tuesday, November 22, 2022
Neil Gross, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported that 63.3% of patients with stage II–IV cutaneous squamous cell carcinoma treated with cemiplimab-rwlc before surgery achieved a pathologic complete response and a major pathologic response. These findings, which were presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 789O), were also published in The New England Journal of Medicine.
“These results represent the highest response rate to neoadjuvant anti–PD-1 monotherapy in any solid cancer so far and likely are the start of a practice change for how we treat advanced, resectable cutaneous squamous cell carcinoma,” said Dr. Gross in an MD Anderson press release.
Patients with stage II–IV cutaneous squamous cell carcinoma received cemiplimab at 350 mg intravenously for 3 weeks for up to four doses before curative-intent surgery. The data cutoff was December 2021.
The study included 79 patients in the United States, Australia, and Europe. Of them, 67 were male, and the median age was 73 years. A total of 60 patients had stage 0 disease, 19 had stage I disease, 5 patients had stage II disease, 38 patients had stage III disease, and 36 patients had stage IV (M0) disease. Overall, 62 patients received all four doses, and 70 underwent surgery.
A pathologic complete response was observed in 40 patients (50.6%). A major pathologic response was observed in an additional 10 patients (12.7%), with less than 10% viable tumor found at surgery. The objective response rate was 68.4%. In total, 16 patients had stable disease, 8 patients had progressive disease, and 1 patient was nonevaluable.
The most common adverse events regardless of attribution (all grades) were fatigue (30.4%), maculopapular rash (13.9%), diarrhea (13.9%), and nausea (13.9%). A total of 14 patients experienced ≥ grade 3 adverse events. Four patients died of adverse events.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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