First-line of penpulimab and chemotherapy for advanced non-melanoma cutaneous carcinoma: A single center, single arm, exploratory study.

Abstract

e21510 Background: Non-melanoma cutaneous carcinoma is a rare subtype malignancy including basal cell carcinoma, squamous cell carcinoma and appendage carcinoma. This study aims to explore the efficacy and safety of penpulimab combined with chemotherapy in advanced non-melanoma cutaneous carcinoma. Methods: Patients were eligible if they were aged 18 through 80 years; had histologically confirmed basal cell carcinoma, squamous cell carcinoma and appendage carcinoma with TNM clinical stage IIIB-IV; had received no previous systemic therapy. Penpulimab (200mg, every 21 days) was given on day 1 until disease progression, unacceptable toxic effects, withdrawal of consent, death, or initiation of new antitumor therapy, whichever occurred first. Fluorouracil (2.5g/m2) and cisplatin or nedaplatin (75mg/m2) were given for 6 cycles. The primary endpoint was objective response rate (ORR) defined by the RECIST v1.1 guideline, and the secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS) and adverse effects (AEs). Results: 15 patients were enrolled from June 3, 2021, through December 24, 2023. The median age was 66 years (range, 42-78 years). 13 patients were males (86.7%) and 2 were females (13.3%). There were 7 cases of appendage carcinoma (46.7%), 6 cases of squamous cell carcinoma (40%), and 2 cases of basal cell carcinoma (13.3%). Among them, there were 4 cases of stage IIIB (26.7%) and 11 cases of stage IV (73.3%). Among the 15 patients, 12 underwent efficacy evaluation, including 4 partial response (PR), 5 stable disease (SD), and 4 progression disease (PD). The objective response rate was 33.3%, and the disease control rate was 66.7%. There was 8 patients experienced disease progression, with a median progression free survival of 3.83 (range,1.5-18.7) months. 4 patients died, and the median overall survival has not yet been reached. AEs related to any component of the trial regimen occurred in 13 (86.7%) patients, the most frequent AEs were grade 1-2. The most common AEs included nausea/vomiting (86.7%), fever (26.7%), thrombocytopenia (26.7%), leukopenia (26.7%), anemia (20%), hypothyroidism (13.3%), hypokalemia (6.7%), rash (6.7%). Only two patients (13.3%) refused therapy because of experiencing unacceptable nausea/vomiting. Conclusions: Penpulimab combined with chemotherapy achieved high response rate and disease control rate in the treatment of newly diagnosed advanced non-melanoma cutaneous carcinoma, with good safety, and may become a new treatment option. Disclosure: All authors have declared no conflicts of interest. Clinical trial information: ChiCTR2200063777.