Although chronic lymphocytic leukemia (CLL) predominantly affects the elderly, limited data exists about the outcomes of over 80-year-old patients, usually underrepresented in clinical trials. We conducted a multicenter study enrolling 79 consecutive CLL patients >= 80 years at the time of frontline therapy, all treated with ibrutinib. Nearly 48% of cases exhibited unmutated IGHV genes, 32% 17p deletion, and 39.2% TP53 mutations; 63.3% displayed a cumulative illness rating scale (CIRS) > 6. The overall response rate on ibrutinib, computed in 74/79 patients (5 patients excluded for early withdrawal), was 89.9%. After a median follow-up of 28.9 months, the median progression-free survival (PFS) and overall survival (OS) were 42.5 and 51.8 months, respectively. CIRS>6 and temporary discontinuation of ibrutinib lasting for 7-30 days were the only parameters associated with a significantly shorter PFS and were both relevant in predicting a shorter PFS compared to patients with CIRS <= 6 and therapy discontinuation <= 7 days. The most common grade >= 3 adverse events were infections (25.5%), neutropenia (10.1%), and anemia (2.5%). Eighteen patients (22.8%) experienced a cardiovascular event, including grade-2 atrial fibrillation (n = 9; 11%), grade-2 hypertension (n = 5; 6%), heart failure (n = 3; 3%), and acute coronary syndrome (n = 1; 1%). Mild bleeding events were observed in 27 patients (34.2%). Ibrutinib was permanently discontinued in 26 patients due to progressive disease (n = 11, including 5 Richter's syndromes), secondary malignancies (n = 6), infections (n = 3), cardiac failure (n = 3), severe bleeding (n = 2), and sudden death (n = 1). In conclusion, our analyses confirmed the overall effectiveness and favorable safety profile of the ibrutinib-single agent therapeutic approach in CLL patients >= 80 years.
Ibrutinib as first line therapy in chronic lymphocytic leukemia patients over 80 years old: A retrospective real‐life multicenter Italian cohort / Martino, Enrica Antonia; Mauro, Francesca Romana; Reda, Gianluigi; Laurenti, Luca; Visentin, Andrea; Frustaci, Annamaria; Vigna, Ernesto; Pepe, Sara; Catania, Gioacchino; Loseto, Giacomo; Murru, Roberta; Chiarenza, Annalisa; Sportoletti, Paolo; Del Principe, Maria Ilaria; Laureana, Roberta; Coscia, Marta; Galimberti, Sara; Ferretti, Eleonora; Zucchetto, Antonella; Bomben, Riccardo; Polesel, Jerry; Tedeschi, Alessandra; Rossi, Davide; Trentin, Livio; Neri, Antonino; Morabito, Fortunato; Gattei, Valter; Gentile, Massimo. - In: HEMATOLOGICAL ONCOLOGY. - ISSN 0278-0232. - 42:1(2024). [10.1002/hon.3249]
Ibrutinib as first line therapy in chronic lymphocytic leukemia patients over 80 years old: A retrospective real‐life multicenter Italian cohort
Mauro, Francesca Romana;Pepe, Sara;
2024
Abstract
Although chronic lymphocytic leukemia (CLL) predominantly affects the elderly, limited data exists about the outcomes of over 80-year-old patients, usually underrepresented in clinical trials. We conducted a multicenter study enrolling 79 consecutive CLL patients >= 80 years at the time of frontline therapy, all treated with ibrutinib. Nearly 48% of cases exhibited unmutated IGHV genes, 32% 17p deletion, and 39.2% TP53 mutations; 63.3% displayed a cumulative illness rating scale (CIRS) > 6. The overall response rate on ibrutinib, computed in 74/79 patients (5 patients excluded for early withdrawal), was 89.9%. After a median follow-up of 28.9 months, the median progression-free survival (PFS) and overall survival (OS) were 42.5 and 51.8 months, respectively. CIRS>6 and temporary discontinuation of ibrutinib lasting for 7-30 days were the only parameters associated with a significantly shorter PFS and were both relevant in predicting a shorter PFS compared to patients with CIRS <= 6 and therapy discontinuation <= 7 days. The most common grade >= 3 adverse events were infections (25.5%), neutropenia (10.1%), and anemia (2.5%). Eighteen patients (22.8%) experienced a cardiovascular event, including grade-2 atrial fibrillation (n = 9; 11%), grade-2 hypertension (n = 5; 6%), heart failure (n = 3; 3%), and acute coronary syndrome (n = 1; 1%). Mild bleeding events were observed in 27 patients (34.2%). Ibrutinib was permanently discontinued in 26 patients due to progressive disease (n = 11, including 5 Richter's syndromes), secondary malignancies (n = 6), infections (n = 3), cardiac failure (n = 3), severe bleeding (n = 2), and sudden death (n = 1). In conclusion, our analyses confirmed the overall effectiveness and favorable safety profile of the ibrutinib-single agent therapeutic approach in CLL patients >= 80 years.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.