Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
Pau Abrisqueta, Javier Loscertales, María José Terol, Ángel Ramírez Páyer, Macarena Ortiz, Inmaculada Pérez, Carolina Cuéllar‐García, Margarita Fernández de la Mata, Alicia Rodríguez, Ana Rodríguez‐Villa Lario, Julio Delgado, Ana Cristina Godoy, José Ma Arguiñano Pérez, M J Berruezo, Ana Carla Oliveira, José‐Ángel Hernández‐Rivas, María Dolores García Malo, Ángeles Medina, Paloma García Martín, Santiago Osorio, Patrícia Baltasar, Miguel Fernández-Zarzoso, Fernando Marco, Ma Jesús Vidal Manceñido, Alicia Smucler Simonovich, Montserrat López Rubio, Isidro Jarque, Alexia Suárez, Rubén Fernández Álvarez, Aima Lancharro Anchel, Eduardo Ríos, María del Carmen Losada Castillo, Ernesto Pérez Persona, Ricardo García Muñoz, Rafael Ramos, Lucrecia Yáñez, José Belló, Cristina Loriente, Daniel Acha, Miguel Villanueva
Abstract
BACKGROUND: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibrutinib in routine clinical practice in Spain. PATIENTS: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019. RESULTS: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated IGHV. Common grade ≥3 adverse events were infections (12.2%) and bleeding (3%). Grade ≥3 AF occurred in 1.5% of patients. CONCLUSION: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations.