Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

BackgroundCutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer whose incidence is growing parallel to the lengthening of the average lifespan. Cemiplimab, an antiPD-1 monoclonal antibody, is the first approved immunotherapy for patients with locally advanced CSCC (laCSCC) o...

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Autores principales:	Sabino Strippoli, Annarita Fanizzi, Davide Quaresmini, Annalisa Nardone, Andrea Armenio, Francesco Figliuolo, Raffaele Filotico, Livia Fucci, Fabio Mele, Michele Traversa, Federica De Luca, Elisabetta Sara Montagna, Eustachio Ruggieri, Simona Ferraiuolo, Francesco Macina, Stefania Tommasi, Angela Monica Sciacovelli, Ivana De Risi, Anna Albano, Raffaella Massafra, Michele Guida
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	cemiplimab advanced cutaneous squamous cell carcinoma checkpoint inhibitors elderly patients immunocompromised patients Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/e3cb353df58947c7904f8a685506ef5d
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spelling	oai:doaj.org-article:e3cb353df58947c7904f8a685506ef5d2021-11-08T05:30:04ZCemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy2234-943X10.3389/fonc.2021.686308https://doaj.org/article/e3cb353df58947c7904f8a685506ef5d2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fonc.2021.686308/fullhttps://doaj.org/toc/2234-943XBackgroundCutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer whose incidence is growing parallel to the lengthening of the average lifespan. Cemiplimab, an antiPD-1 monoclonal antibody, is the first approved immunotherapy for patients with locally advanced CSCC (laCSCC) or metastatic CSCC (mCSCC) thanks to phase I and II studies showing high antitumor activity and good tolerability. Nevertheless, at present, very few data are available regarding cemiplimab in real-life experience and in frail, elderly, and immunosuppressed patients as well as regarding biomarkers able to predict response so as to guide therapeutic choices.Patients and MethodsWe built a retroprospective cohort study including 30 non-selected patients with laCSCC (25) and mCSCC (five) treated with cemiplimab from August 2019 to November 2020. Clinical outcomes, toxicity profile, and correlations with disease, patients, and peripheral blood parameters are explored.ResultsThe median age was 81 years (range, 36–95), with 24 males and five patients having an immunosuppressive condition, while the frailty prevalence was 83% based on index derived from age, Eastern Cooperative Oncology Group performance status, and Charlson Comorbidity Index. We reported 23 responses (76.7%) with nine complete responses (30%). A statistically significant higher response rate was observed in head and neck primary tumors and in patients with hemoglobin level >12 g/dl. No difference was observed with respect to frailty, median age, sex, and body mass index. The baseline low neuthophil/lymphocyte ratio and low platelet/lymphocyte ratio resulted to be also correlated with a better response. Moreover, lymphocyte, neutrophil, and monocyte behaviors had an opposite trend in responders and non-responders. An overall response was reported in four of five immunosuppressed patients. Seventeen patients (57.6%) have an ongoing response and are still alive. Six responders had interrupted treatment (two for toxicity and four for personal choice) but maintained their response. The treatment was well tolerated by the majority of patients. The most common adverse events were fatigue in seven patients (23.3%) and skin toxicity in 10 patients (33.3%), including pruritus in six patients, rash in three patients, and bullous erythema in one patient.ConclusionsIn our real-life experience, cemiplimab showed a high antitumor activity with acceptable safety profile similar to those in trials with selected patients. Moreover, its antitumor activity resulted to be not impaired in very elderly patients and in those with immunocompromised status.Sabino StrippoliAnnarita FanizziDavide QuaresminiAnnalisa NardoneAndrea ArmenioFrancesco FigliuoloRaffaele FiloticoLivia FucciFabio MeleMichele TraversaFederica De LucaElisabetta Sara MontagnaEustachio RuggieriSimona FerraiuoloFrancesco MacinaStefania TommasiAngela Monica SciacovelliIvana De RisiAnna AlbanoRaffaella MassafraMichele GuidaFrontiers Media S.A.articlecemiplimabadvanced cutaneous squamous cell carcinomacheckpoint inhibitorselderly patientsimmunocompromised patientsNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENFrontiers in Oncology, Vol 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	cemiplimab advanced cutaneous squamous cell carcinoma checkpoint inhibitors elderly patients immunocompromised patients Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	cemiplimab advanced cutaneous squamous cell carcinoma checkpoint inhibitors elderly patients immunocompromised patients Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Sabino Strippoli Annarita Fanizzi Davide Quaresmini Annalisa Nardone Andrea Armenio Francesco Figliuolo Raffaele Filotico Livia Fucci Fabio Mele Michele Traversa Federica De Luca Elisabetta Sara Montagna Eustachio Ruggieri Simona Ferraiuolo Francesco Macina Stefania Tommasi Angela Monica Sciacovelli Ivana De Risi Anna Albano Raffaella Massafra Michele Guida Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
description	BackgroundCutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer whose incidence is growing parallel to the lengthening of the average lifespan. Cemiplimab, an antiPD-1 monoclonal antibody, is the first approved immunotherapy for patients with locally advanced CSCC (laCSCC) or metastatic CSCC (mCSCC) thanks to phase I and II studies showing high antitumor activity and good tolerability. Nevertheless, at present, very few data are available regarding cemiplimab in real-life experience and in frail, elderly, and immunosuppressed patients as well as regarding biomarkers able to predict response so as to guide therapeutic choices.Patients and MethodsWe built a retroprospective cohort study including 30 non-selected patients with laCSCC (25) and mCSCC (five) treated with cemiplimab from August 2019 to November 2020. Clinical outcomes, toxicity profile, and correlations with disease, patients, and peripheral blood parameters are explored.ResultsThe median age was 81 years (range, 36–95), with 24 males and five patients having an immunosuppressive condition, while the frailty prevalence was 83% based on index derived from age, Eastern Cooperative Oncology Group performance status, and Charlson Comorbidity Index. We reported 23 responses (76.7%) with nine complete responses (30%). A statistically significant higher response rate was observed in head and neck primary tumors and in patients with hemoglobin level >12 g/dl. No difference was observed with respect to frailty, median age, sex, and body mass index. The baseline low neuthophil/lymphocyte ratio and low platelet/lymphocyte ratio resulted to be also correlated with a better response. Moreover, lymphocyte, neutrophil, and monocyte behaviors had an opposite trend in responders and non-responders. An overall response was reported in four of five immunosuppressed patients. Seventeen patients (57.6%) have an ongoing response and are still alive. Six responders had interrupted treatment (two for toxicity and four for personal choice) but maintained their response. The treatment was well tolerated by the majority of patients. The most common adverse events were fatigue in seven patients (23.3%) and skin toxicity in 10 patients (33.3%), including pruritus in six patients, rash in three patients, and bullous erythema in one patient.ConclusionsIn our real-life experience, cemiplimab showed a high antitumor activity with acceptable safety profile similar to those in trials with selected patients. Moreover, its antitumor activity resulted to be not impaired in very elderly patients and in those with immunocompromised status.
format	article
author	Sabino Strippoli Annarita Fanizzi Davide Quaresmini Annalisa Nardone Andrea Armenio Francesco Figliuolo Raffaele Filotico Livia Fucci Fabio Mele Michele Traversa Federica De Luca Elisabetta Sara Montagna Eustachio Ruggieri Simona Ferraiuolo Francesco Macina Stefania Tommasi Angela Monica Sciacovelli Ivana De Risi Anna Albano Raffaella Massafra Michele Guida
author_facet	Sabino Strippoli Annarita Fanizzi Davide Quaresmini Annalisa Nardone Andrea Armenio Francesco Figliuolo Raffaele Filotico Livia Fucci Fabio Mele Michele Traversa Federica De Luca Elisabetta Sara Montagna Eustachio Ruggieri Simona Ferraiuolo Francesco Macina Stefania Tommasi Angela Monica Sciacovelli Ivana De Risi Anna Albano Raffaella Massafra Michele Guida
author_sort	Sabino Strippoli
title	Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
title_short	Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
title_full	Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
title_fullStr	Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
title_full_unstemmed	Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy
title_sort	cemiplimab in an elderly frail population of patients with locally advanced or metastatic cutaneous squamous cell carcinoma: a single-center real-life experience from italy
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/e3cb353df58947c7904f8a685506ef5d
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Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

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