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. 2024 Jun 8;73(8):160.
doi: 10.1007/s00262-024-03728-z.

Impact of cemiplimab treatment duration on clinical outcomes in advanced cutaneous squamous cell carcinoma

Domenico Mallardo  1 , Francesca Sparano  1 , Maria Grazia Vitale  1 , Claudia Trojaniello  1 , Mario Fordellone  2 , Eleonora Cioli  1 , Assunta Esposito  1 , Lucia Festino  1 , Mario Mallardo  1 , Vito Vanella  1 , Bianca Arianna Facchini  1 , Rosaria De Filippi  3 , Paolo Meinardi  4 , Margaret Ottaviano  1 , Corrado Caracò  4 , Ester Simeone  1 , Paolo Antonio Ascierto  5
Affiliations

Impact of cemiplimab treatment duration on clinical outcomes in advanced cutaneous squamous cell carcinoma

Domenico Mallardo et al. Cancer Immunol Immunother. .

Abstract

Treatment duration with checkpoint inhibitors must be optimized to prevent unjustified toxicity, but evidence for the management of cutaneous squamous cell carcinoma is lacking. A retrospective study was performed to evaluate the survival of patients with cutaneous squamous cell carcinoma (CSCC) who discontinued cemiplimab due to different causes and without progression. Among 95 patients with CSCC who received cemiplimab, 22 (23%) patients discontinued immunotherapy due to causes other than progression, such as comorbidities, toxicity, complete response or lack of compliance (group that discontinued before censoring [DBC]), then 73 patients had standard treatment scheduled (STS). The overall survival was 25.2 months (95% CI: 8.9-29.4) in STS group and 28.3 months (95% CI: 12.7-28.3) in the DBC group; deaths for all causes were 11/22 (50%) in the DBC group and 34/73 (46.6%) in the STS group (p = 0.32). 10/22 (45.4%) subjects died due to CSCC in the DBC after discontinuation and 34/73 (46.6%) in the STS group, and the difference between groups was not significant (p = 0.230). Duration of treatment was significantly lower in subjects with stable disease versus those with complete or partial response (16.9, 30.6 and 34.9 months, respectively; p = 0.004). Among the 22 STS patients, 12 received cemiplimab for less than 12 months (10 [83%] died) and 10 for at least 12 months (1 [10%] died). Our observation, finding no outcome difference between DBC and STS groups, suggests that ICI treatment after one year might expose patients to further treatment related events without efficacy advantages.

Keywords: Anti-PD1; Cemiplimab; Cutaneous squamous cell carcinoma; Duration of response; Immune checkpoint inhibitors; Immunotherapy.

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Conflict of interest statement

PAA has/had a consultant/advisory role for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, AstraZeneca, Sun Pharma, Sanofi, Idera, Sandoz, Immunocore, 4SC, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, Oncosec, Nouscom, Lunaphore, Seagen, iTeos, Medicenna, Bio-Al Health. He also received research funding from Bristol Myers Squibb, Roche-Genentech, Pfizer, Sanofi. AC received grant consultancies from BMS, Astrazeneca, Roche and MSD. He also received speaker’s fee from Astrazeneca, Novartis and Eisai.

Figures

Fig. 1
Fig. 1
Treatments and disposition of cutaneous squamous cell carcinoma patients included in the study. ICI: immune checkpoint inhibitors; CSCC: cutaneous squamous cell carcinoma
Fig. 2
Fig. 2
Duration of treatment according to response to treatment. CR: complete response; PR: partial response; SD: stable disease; PD: progression disease
Fig. 3
Fig. 3
Overall survival in the whole population and in the subgroup that discontinued cemiplimab without progressive disease. DBC: discontinued before censoring; STS: standard treatment scheduled
Fig. 4
Fig. 4
Disease-specific survival in the standard treatment scheduled and discontinued before censoring groups. DBC: discontinued before censoring; STS: standard treatment scheduled
Fig. 5
Fig. 5
Progression-free survival in the standard treatment scheduled and discontinued before censoring groups. DBC: discontinued before censoring; STS: standard treatment scheduled
Fig. 6
Fig. 6
Clinical course of the 22 patients in the discontinued before censoring group
See this image and copyright information in PMC

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