Letermovir Prophylaxis for Cytomegalovirus Infection in Allogeneic Stem Cell Transplantation: A Real-World Experience

• Main Authors: Massimo Martino, Annalisa Pitino, Mercedes Gori, Benedetto Bruno, Alessandra Crescimanno, Vincenzo Federico, Alessandra Picardi, Stefania Tringali, Claudia Ingrosso, Paola Carluccio, Domenico Pastore, Gerardo Musuraca, Annalisa Paviglianiti, Adriana Vacca, Bianca Serio, Gabriella Storti, Nicola Mordini, Salvatore Leotta, Michele Cimminiello, Lucia Prezioso, Barbara Loteta, Anna Ferreri, Fabrizia Colasante, Emanuela Merla, Luisa Giaccone, Alessandro Busca, Maurizio Musso, Renato Scalone, Nicola Di Renzo, Serena Marotta, Patrizio Mazza, Pellegrino Musto, Immacolata Attolico, Carmine Selleri, Filippo Antonio Canale, Marta Pugliese, Giovanni Tripepi, Gaetana Porto, Giovanni Martinelli, Angelo Michele Carella, Claudio Cerchione
• Format: Article
• Language: English
• Published: Frontiers Media S.A. 2021-09-01
• Series: Frontiers in Oncology
• Subjects: cytomegalovirus infection; allogeneic stem cell transplantation; prophylaxis; real-world data; Letermovir
• Online Access: https://www.frontiersin.org/articles/10.3389/fonc.2021.740079/full
• ISSN: 2234-943X

Despite effective treatments, cytomegalovirus (CMV) continues to have a significant impact on morbidity and mortality in allogeneic stem cell transplant (allo-SCT) recipients. This multicenter, retrospective, cohort study aimed to evaluate the reproducibility of the safety and efficacy of commercially available letermovir for CMV prophylaxis in a real-world setting. Endpoints were rates of clinically significant CMV infection (CSCI), defined as CMV disease or CMV viremia reactivation within day +100-+168. 204 adult CMV-seropositive allo-SCT recipients from 17 Italian centres (median age 52 years) were treated with LET 240 mg/day between day 0 and day +28. Overall, 28.9% of patients underwent a haploidentical, 32.4% a matched related, and 27.5% a matched unrelated donor (MUD) transplant. 65.7% were considered at high risk of CSCI and 65.2% had a CMV seropositive donor. Low to mild severe adverse events were observed in 40.7% of patients during treatment [gastrointestinal toxicity (36.3%) and skin rash (10.3%)]. Cumulative incidence of CSCI at day +100 and day +168 was 5.4% and 18.1%, respectively, whereas the Kaplan-Meier event rate was 5.8% (95% CI: 2.4-9.1) and 23.3% (95% CI: 16.3-29.7), respectively. Overall mortality was 6.4% at day +100 and 7.3% at day +168. This real-world experience confirms the efficacy and safety of CMV.