Julie Valentin1, Emilie Gérard1, Thomas Ferte2, Sorilla Prey3, Léa Dousset3, Caroline Dutriaux3, Marie Beylot-Barry4, Anne Pham-Ledard5. 1. Dermatology Department, CHU Bordeaux, F-33000 Bordeaux, France. 2. Pôle de Santé Publique, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique, CHU de Bordeaux, Bordeaux, France. 3. Dermatology Department, CHU Bordeaux, F-33000 Bordeaux, France; Univ. Bordeaux, INSERM U1035, F-33076 Bordeaux, France. 4. Dermatology Department, CHU Bordeaux, F-33000 Bordeaux, France; Univ. Bordeaux, INSERM U1053, Team 3 Oncogenesis of Cutaneous Lymphoma, F-33076 Bordeaux, France. 5. Dermatology Department, CHU Bordeaux, F-33000 Bordeaux, France; Univ. Bordeaux, INSERM U1053, Team 3 Oncogenesis of Cutaneous Lymphoma, F-33076 Bordeaux, France. Electronic address: anne.pham-ledard@chu-bordeaux.fr.
Abstract
INTRODUCTION: Locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) mostly affects older and frail patients. Cemiplimab is an anti-PD1 antibody used in this indication since its approval by the FDA and the EMA in 2019 after encouraging results from phase II trials. We aimed to evaluate cemiplimab safety in patients from daily practice. METHODS: Retrospective and monocentric study including all patients who received at least one infusion of cemiplimab between August 2018 and September 2019. Adverse effects (AEs), treatment interruption, and efficacy were recorded (data cut-off, November 1st 2020). RESULTS: Twenty-two patients were included, median age was 83 [55-93], 73% were Eastern Cooperative Oncology Group (ECOG) 0 or 1, 36% were immune compromised. After a median time on treatment of six months [0.7-22], seventeen patients (77%) experienced 24 AEs, comprising 45% serious AEs (SAEs) grade ≥ 3 and one SAE grade 5 (myositis). Patients who presented SAEs were all >65 years old. Nine patients (41%) definitively discontinued treatment due to AEs. Seventeen patients were evaluable, after a median follow-up of eleven months [1-22], 32% had an objective response (2 complete and 5 partial responses), 47% had controlled disease and 35% experienced progression. CONCLUSIONS: In our cohort, safety seemed to be worse than in phase II trial with more treatment discontinuations due to cemiplimab toxicity, probably reflecting the distinct demographic and medical characteristics of patients in daily care.
INTRODUCTION: Locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) mostly affects older and frail patients. Cemiplimab is an anti-PD1 antibody used in this indication since its approval by the FDA and the EMA in 2019 after encouraging results from phase II trials. We aimed to evaluate cemiplimab safety in patients from daily practice. METHODS: Retrospective and monocentric study including all patients who received at least one infusion of cemiplimab between August 2018 and September 2019. Adverse effects (AEs), treatment interruption, and efficacy were recorded (data cut-off, November 1st 2020). RESULTS: Twenty-two patients were included, median age was 83 [55-93], 73% were Eastern Cooperative Oncology Group (ECOG) 0 or 1, 36% were immune compromised. After a median time on treatment of six months [0.7-22], seventeen patients (77%) experienced 24 AEs, comprising 45% serious AEs (SAEs) grade ≥ 3 and one SAE grade 5 (myositis). Patients who presented SAEs were all >65 years old. Nine patients (41%) definitively discontinued treatment due to AEs. Seventeen patients were evaluable, after a median follow-up of eleven months [1-22], 32% had an objective response (2 complete and 5 partial responses), 47% had controlled disease and 35% experienced progression. CONCLUSIONS: In our cohort, safety seemed to be worse than in phase II trial with more treatment discontinuations due to cemiplimab toxicity, probably reflecting the distinct demographic and medical characteristics of patients in daily care.
Authors: Neil K Mehta; Andraia R Li; Shaun A Nguyen; John M Kaczmar; David M Neskey; Terry A Day Journal: Target Oncol Date: 2021-10-22 Impact factor: 4.864
Authors: Giulia Bertino; Ales Groselj; Luca G Campana; Christian Kunte; Hadrian Schepler; Julie Gehl; Tobian Muir; James A P Clover; Pietro Quaglino; Erika Kis; Matteo Mascherini; Brian Bisase; Giancarlo Pecorari; Falk Bechara; Paolo Matteucci; Joy Odili; Francesco Russano; Antonio Orlando; Rowan Pritchard-Jones; Graeme Moir; David Mowatt; Barbara Silvestri; Veronica Seccia; Werner Saxinger; Francesca de Terlizzi; Gregor Sersa Journal: Front Oncol Date: 2022-09-20 Impact factor: 5.738