Real-life efficacy and safety of cemiplimab in advanced cervical cancer from a nominal use program in Italy: The MITO 44 study.

Autor: Tuninetti V; Department of Oncology, University of Turin, Medical Oncology, Ordine Mauriziano Hospital, Italy. Electronic address: dr.ssatuninettivalentina@gmail.com., Virano E; Department of Oncology, University of Turin, 10124 Turin, Italy., Salutari V; Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy., Ricotti A; Clinical Trial, Ordine Mauriziano Hospital, 10128 Turin, Italy., Pisano C; Dipartimento Uro-Ginecologico, Istituto Nazionale Tumori di Napoli Fondazione G Pascale IRCCS, Naples, Italy., Ducceschi M; Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy., Turitto G; Division of Oncology, AORN 'Sant' Anna e San Sebastiano', Caserta, Italy., Scandurra G; Medical Oncology Unit, Cannizzaro Hospital, Catania, Italy., Petrella MC; Oncologia Medica Ginecologica, Azienda Universitaria Ospedaliera Careggi, Firenze, Italy., Forestieri V; Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy., Rizzetto M; Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, 33081 Aviano, Italy., Mammoliti S; IRCCS Ospedale Policlinico San Martino, Genova, Italy., Artioli G; Ulss2 Oncologia Medica Marca Trevigiana, Treviso, Italy., Cioffi R; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy; Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy, Vita-Salute San Raffaele University, Milan, Italy., Borsotti L; Clinical Trial, Ordine Mauriziano Hospital, 10128 Turin, Italy., Bellero M; SC Farmacia Ospedaliera, Ordine Mauriziano Hospital, 10028 Turin, Italy., Rognone C; Department of Oncology, University of Turin, Medical Oncology, Ordine Mauriziano Hospital, Italy., Carbone V; Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy., Ferrandina G; Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy., Mantiero M; Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy., Azzolina C; SC Direzione Sanitaria, Ordine Mauriziano Hospital, 10028 Turin, Italy., Geninatti E; Department of Oncology, University of Turin, Medical Oncology, Ordine Mauriziano Hospital, Italy., Pignata S; Dipartimento Uro-Ginecologico, Istituto Nazionale Tumori di Napoli Fondazione G Pascale IRCCS, Naples, Italy., Valabrega G; Department of Oncology, University of Turin, Medical Oncology, Ordine Mauriziano Hospital, Italy.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2024 May; Vol. 203, pp. 114039. Date of Electronic Publication: 2024 Mar 30.
DOI: 10.1016/j.ejca.2024.114039
Abstrakt: Background: cemiplimab is an immunoglobulin G4 monoclonal antibody targeting the programmed cell death-1 receptor. A nominal use program is available in Italy in advanced cervical cancer (CC) patients treated with platinum based chemotherapy based on the results of EMPOWER-Cervical 1/GOG-3016/ENGOTcx9 trial. This real-world, retrospective cohort, multicenter study aimed at describing clinical outcomes of patients with advanced CC treated with cemiplimab in Italy.
Methods: The primary objective of the study was to assess the feasibility and the replicability of the initial results in a real world setting of cemiplimab nominal use. The primary endpoint of our analysis was progression free survival (PFS). Secondary endpoints included overall response rate (ORR), overall survival (OS) and safety data.
Results: From March 2022 to December 2023, 135 patients were treated in 12 Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) Centers. Forty-two percent of patients had one or more comorbidities, hypertension being the most common (23.4%). Median PFS was 4.0 months (range 3.0-6.0) and median OS was 12.0 months (12.0- NR) with no differences according to PD-L1 status. Complete response (CR) or no evidence of disease (NED) were observed in 8.6%; partial response (PR) in 21.1%, stable disease (SD) in 14.8% and progression was recorded in 44.5% of patients. Most common drug related adverse events (AEs) were anemia (39.1%) and fatigue (27.8%). Immune related AEs occurred in 18.0%.
Conclusions: This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Valentina Tuninetti: honoraria from MSD Oncology, GSK and EISAI, Elisa Virano: None declared, Vanda Salutari: Honoraria: AstraZeneca, MSD Oncology, GSK, PhamaMar, Novocure, Consulting: AstraZeneca, Novocure, Travel, Accomodations, Expenses: GSK, PharmaMar, Andrea Ricotti: None declared, Carmela Pisano: Advisory board: AstraZeneca, MSD Oncology, GSK, Monica Ducceschi: None declared, Giacinto Turitto: None declared, Giuseppa Scandurra: None declared, Maria Cristina Petrella: Honoraria from Astrazeneca, MSD, GSK, Valeria Forestieri: None declared, Monica Rizzetto: None declared, Serafina Mammoliti: None declared, Grazia Artioli: honoraria from AstraZeneca, MSD Oncology, GSK, Raffaella Cioffi: None declared, Lucia Borsotti: None declared, Marco Bellero: None declared, Chiara Rognone: None declared, Vittoria Carbone: None declared, Gabriella Ferrandina: None declared, Mara Mantiero: None declared, Carmen Azzolina: None declared, Eleonora Geninatti: None declared, Sandro Pignata: Research Funding: AstraZeneca, MSD Oncology, Roche, GSK, Pfizer, Honoraria: AstraZeneca, MSD Oncology, Roche, GSK, Novartis, EISAI, PharmaMar, Giorgio Valabrega: Consulting fees from GSK; honoraria from AstraZeneca, GSK, and MSD; travel support from AstraZeneca and PharmaMar; participation in advisory boards for AstraZeneca, EISAI, GSK, and MSD.
(Copyright © 2024 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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