Posted: Friday, January 14, 2022
As the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC), cemiplimab represents a paradigm shift. Nonetheless, according to Michele Guida, MD, of Istituto Tumori Giovanni Paolo II, Bari, Italy, and colleagues, the phase I and II studies supporting the approval of this anti–PD-1 monoclonal antibody may have underrepresented elderly and frail individuals with a poor performance status and significant comorbidities; advanced disease has been found to occur most frequently in this population of patients.
Thus, the authors undertook a single-center retrospective study of cemiplimab in a group of 30 unselected patients with advanced CSCC (24 male; median age, 81 years; frailty prevalence, 83%). The team reported in Frontiers in Oncology, cemiplimab demonstrated high antitumor activity and acceptable safety, just as it did in trials with selected patients.
A total of 23 patients responded, including 9 with complete responses. At a median follow-up of 10 months, 57.6% of patients had no disease progression. Significantly higher response rates were observed in patients with head and neck primary tumors (P = .016) and in those with hemoglobin levels greater than 12 g/dL (Wilcoxon-Mann-Whitney P = .042). Also, the investigators emphasized, four of the five patients with an immunosuppressive condition had an overall response.
The treatment was mostly well tolerated, with three patients experiencing adverse events of grade 3 or 4. The most common adverse events were skin toxicity and fatigue.
“Moreover, in three patients treated with concomitant radiotherapy, we documented no additional toxicity,” Dr. Guida and co-researchers pointed out. “This combined therapeutic strategy deserves further investigation, due to its interesting biological rationale of a synergic action between radiation [therapy] and immunotherapy with checkpoint inhibitors, as already demonstrated in [other] types of cancer.”
Disclosure: The study authors reported no conflicts of interest.