Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)

Abrisqueta P. ; Loscertales J. ; Terol M.J. ; Ramírez Payer Á. ; Ortiz M. ; Pérez I. ; Cuellar-García C. ; Fernández de la Mata M. ; Rodríguez A. ; Lario A. ; Delgado J. ; Godoy A. (Universidad de Zaragoza) ; Arguiñano Pérez J.M. ; Berruezo M.J. ; Oliveira A. ; Hernández-Rivas J.-Á. ; García Malo M.D. ; Medina Á. ; García Martin P. ; Osorio S. ; Baltasar P. ; Fernández-Zarzoso M. ; Marco F. ; Vidal Manceñido M.J. ; Smucler Simonovich A. ; López Rubio M. ; Jarque I. ; Suarez A. ; Fernández Álvarez R. ; Lancharro Anchel A. ; Ríos E. ; Losada Castillo M.D.C. ; Pérez Persona E. ; García Muñoz R. ; Ramos R. ; Yáñez L. ; Bello J.L. ; Loriente C. ; Acha D. ; Villanueva M.

Resumen: 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.

Idioma: Inglés

DOI: 10.1016/j.clml.2021.07.022

Año: 2021

Publicado en: CLINICAL LYMPHOMA MYELOMA & LEUKEMIA 21, 12 (2021), e985-e999
ISSN: 2152-2650

Factor impacto JCR: 2.822 (2021)

Categ. JCR: HEMATOLOGY rank: 56 / 78 = 0.718 (2021) - Q3 - T3
Categ. JCR: ONCOLOGY rank: 192 / 245 = 0.784 (2021) - Q4 - T3

Tipo y forma: Artículo (Versión definitiva)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)