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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.
  • Martino EA; Hematology Unit, AO Cosenza, Cosenza, Italy.
  • Mauro FR; Hematology, Department of Translational and Precision Medicine, 'Sapienza' University, Rome, Italy.
  • Reda G; Hematology Unit, Fondazione Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Laurenti L; Dipartimento Scienze Radiologiche ed Ematologiche, Divisione di Ematologia Fondazione Policlinico universitario A Gemelli, Rome, Italy.
  • Visentin A; Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua, Padua, Italy.
  • Frustaci A; Department of Haematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Vigna E; Hematology Unit, AO Cosenza, Cosenza, Italy.
  • Pepe S; Hematology, Department of Translational and Precision Medicine, 'Sapienza' University, Rome, Italy.
  • Catania G; A.O.N. SS Antonio e Biagio e C. Arrigo, Alessandria, Italy.
  • Loseto G; IRCCS Oncologico di Bari, Bari, Italy.
  • Murru R; Hematology and Stem Cell Transplantation Unit, Ospedale A. Businco, ARNAS G. Brotzu, Cagliari, Italy.
  • Chiarenza A; Divisione di Ematologia, A.O.U. Policlinico, PO G.Rodolico, Catania, Italy.
  • Sportoletti P; Centro di Ricerca Emato-Oncologica (CREO), Dipartimento di Medicina e Chirurgia, Università di Perugia, Perugia, Italy.
  • Del Principe MI; Ematologia, Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma "Tor Vergata," Rome, Rome, Italy.
  • Laureana R; Ematologia, Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma "Tor Vergata," Rome, Rome, Italy.
  • Coscia M; University Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences, University of Torino, Torino, Italy.
  • Galimberti S; Hematology, University of Pisa, Pisa, Italy.
  • Ferretti E; Clinical Trials Center Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
  • Zucchetto A; Clinical and Experimental Onco-Hematology Unit, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
  • Bomben R; Clinical and Experimental Onco-Hematology Unit, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
  • Polesel J; Unit of Cancer Epidemiology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
  • Tedeschi A; Department of Haematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Rossi D; Oncology Institute of Southern Switzerland and Institute of Oncology Research, Bellinzona, Switzerland.
  • Trentin L; Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua, Padua, Italy.
  • Neri A; Scientific Directorate, Azienda USL-IRCCS of Reggio Emilia, Reggio Emilia, Italy.
  • Morabito F; Biotechnology Research Unit, Cosenza, Italy.
  • Gattei V; Clinical and Experimental Onco-Hematology Unit, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
  • Gentile M; Hematology Unit, AO Cosenza, Cosenza, Italy.
Hematol Oncol ; 42(1): e3249, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38287529
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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Piperidinas / Adenina / Leucemia Linfocítica Crónica de Células B Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged80 / Humans País como asunto: Europa Idioma: En Año: 2024 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Piperidinas / Adenina / Leucemia Linfocítica Crónica de Células B Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged80 / Humans País como asunto: Europa Idioma: En Año: 2024 Tipo del documento: Article