Cancers (Mar 2024)
Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study
- Francesca Romana Mauro,
- Potito Rosario Scalzulli,
- Lydia Scarfò,
- Carla Minoia,
- Roberta Murru,
- Paolo Sportoletti,
- Ferdinando Frigeri,
- Francesco Albano,
- Nicola Di Renzo,
- Alessandro Sanna,
- Luca Laurenti,
- Massimo Massaia,
- Ramona Cassin,
- Marta Coscia,
- Caterina Patti,
- Elsa Pennese,
- Agostino Tafuri,
- Annalisa Chiarenza,
- Piero Galieni,
- Omar Perbellini,
- Carmine Selleri,
- Catello Califano,
- Felicetto Ferrara,
- Antonio Cuneo,
- Marco Murineddu,
- Gaetano Palumbo,
- Ilaria Scortechini,
- Alessandra Tedeschi,
- Livio Trentin,
- Marzia Varettoni,
- Fabrizio Pane,
- Anna Marina Liberati,
- Francesco Merli,
- Lucia Morello,
- Gerardo Musuraca,
- Monica Tani,
- Adalberto Ibatici,
- Giulia Regazzoni,
- Michele Di Candia,
- Maria Palma,
- Danilo Arienti,
- Stefano Molica
Affiliations
- Francesca Romana Mauro
- Ematologia, Sapienza Università di Roma, 00185 Roma, Italy
- Potito Rosario Scalzulli
- Ospedale “Casa Sollievo della Sofferenza”, 71013 San Giovanni Rotondo, Italy
- Lydia Scarfò
- Università Vita-Salute San Raffaele, 20132 Milano, Italy
- Carla Minoia
- Hematology Unit, IRCCS Istituto Tumori “Giovanni Paolo II”, 70124 Bari, Italy
- Roberta Murru
- Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS G. Brotzu, 09134 Cagliari, Italy
- Paolo Sportoletti
- Sezione di Ematologia, Università degli Studi di Perugia, 06123 Perugia, Italy
- Ferdinando Frigeri
- AORN “Sant’Anna e San Sebastiano”, 81100 Caserta, Italy
- Francesco Albano
- Hematology and Stem Cell Transplantation Unit, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari “Aldo Moro”, 70121 Bari, Italy
- Nicola Di Renzo
- UOC Ematologia e Trapianto di Cellule Staminali-PO “Vito Fazzi” ASL Lecce, 73100 Lecce, Italy
- Alessandro Sanna
- AOU Careggi, 50121 Firenze, Italy
- Luca Laurenti
- Policlinico A. Gemelli, 00168 Roma, Italy
- Massimo Massaia
- SC Ematologia-AO S. Croce e Carle, 12100 Cuneo, Italy
- Ramona Cassin
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan, 20122 Milano, Italy
- Marta Coscia
- Dipartimento di Biotecnologie Molecolari e Scienze per la Salute, Università degli Studi di Torino, 10124 Torino, Italy
- Caterina Patti
- UOC Oncoematologia, Ospedali Riuniti Villa Sofia-Cervello, 90146 Palermo, Italy
- Elsa Pennese
- UOC Ematologia Clinica, ASL Pescara, 65124 Pescara, Italy
- Agostino Tafuri
- Ematologia, AOU Sant’Andrea, Sapienza Università di Roma, 00185 Roma, Italy
- Annalisa Chiarenza
- UOC Ematologia, AOU Policlinico G.Rodolico-San Marco, 95123 Catania, Italy
- Piero Galieni
- UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni, 63100 Ascoli Piceno, Italy
- Omar Perbellini
- UOC Ematologia, Azienda ULSS 8 Berica, 36100 Vicenza, Italy
- Carmine Selleri
- Hematology and Bone Marrow Transplant Center, Department of Medicine and Surgery, University of Salerno, 84081 Salerno, Italy
- Catello Califano
- UOC Ematologia, PO Andrea Tortora-Pagani, 84016 Pagani, Italy
- Felicetto Ferrara
- AORN Antonio Cardarelli, 80131 Napoli, Italy
- Antonio Cuneo
- Department of Medical Science, Università degli Studi di Ferrara, 44121 Ferrara, Italy
- Marco Murineddu
- Ematologia, Ospedale San Francesco ASL Nuoro, 08100 Nuoro, Italy
- Gaetano Palumbo
- SC Ematologia, AOU Policlinico Foggia, 71122 Foggia, Italy
- Ilaria Scortechini
- Azienda Ospedaliero Universitaria delle Marche, 60126 Ancona, Italy
- Alessandra Tedeschi
- Divisione di Ematologia, ASST GOM Niguarda, 20162 Milano, Italy
- Livio Trentin
- Dipartimento di Medicina, UOC Ematologia, Università di Padova, 35122 Padova, Italy
- Marzia Varettoni
- Divisione di Ematologia, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Fabrizio Pane
- Division of Hematology, Department of Clinical Medicine and Surgery, Università di Napoli Federico II, 80131 Napoli, Italy
- Anna Marina Liberati
- AO Santa Maria, Università degli Studi Di Perugia, 05100 Terni, Italy
- Francesco Merli
- Ematologia AUSL-IRCCS Reggio Emilia, 42123 Reggio Emilia, Italy
- Lucia Morello
- IRCCS Humanitas Research Hospital-Humanitas Cancer Center, 20089 Rozzano, Italy
- Gerardo Musuraca
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
- Monica Tani
- Haematology Unit, Ospedale S. Maria delle Croci, 48121 Ravenna, Italy
- Adalberto Ibatici
- IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy
- Giulia Regazzoni
- Johnson & Johnson Innovative Medicine, 20126 Milano, Italy
- Michele Di Candia
- Johnson & Johnson Innovative Medicine, 20126 Milano, Italy
- Maria Palma
- Johnson & Johnson Innovative Medicine, 20126 Milano, Italy
- Danilo Arienti
- Johnson & Johnson Innovative Medicine, 20126 Milano, Italy
- Stefano Molica
- Dipartimento Onco-Ematologico, Azienda Ospedaliera Pugliese-Ciaccio, 88100 Catanzaro, Italy
- DOI
- https://doi.org/10.3390/cancers16061228
- Journal volume & issue
-
Vol. 16,
no. 6
p. 1228
Abstract
Real-world data in clinical practice are needed to confirm the efficacy and safety that ibrutinib has demonstrated in clinical trials of patients with chronic lymphocytic leukemia (CLL). We described the real-world persistence rate, patterns of use, and clinical outcomes in 309 patients with CLL receiving single-agent ibrutinib in first line (1L, n = 118), 2L (n = 127) and ≥3L (n = 64) in the prospective, real-world, Italian EVIdeNCE study. After a median follow-up of 23.9 months, 29.8% of patients discontinued ibrutinib (1L: 24.6%, 2L: 29.9%, ≥3L: 39.1%), mainly owing to adverse events (AEs)/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, ≥3L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, ≥3L: 60.9%). The 2-year PFS and OS were, respectively, 85.4% and 91.7% in 1L, 80.0% and 86.2% in 2L, and 70.1% and 80.0% in ≥3L. Cardiovascular conditions did not impact patients’ clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3–4 atrial fibrillation occurred in 3.9% of patients. No new safety signals were detected. These results strongly support ibrutinib as a valuable treatment option for CLL.
Keywords
- chronic lymphocytic leukemia
- ibrutinib
- real-world evidence
- retention
- clinical outcomes
- effectiveness