PMID- 38539561
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 16
IP  - 6
DP  - 2024 Mar 20
TI  - Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients 
      with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study.
LID - 10.3390/cancers16061228 [doi]
LID - 1228
AB  - 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.
FAU - Mauro, Francesca Romana
AU  - Mauro FR
AUID- ORCID: 0000-0003-2425-9474
AD  - Ematologia, Sapienza Universita di Roma, 00185 Roma, Italy.
FAU - Scalzulli, Potito Rosario
AU  - Scalzulli PR
AD  - Ospedale "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy.
FAU - Scarfo, Lydia
AU  - Scarfo L
AD  - Universita Vita-Salute San Raffaele, 20132 Milano, Italy.
AD  - IRCCS Ospedale San Raffaele, 20132 Milano, Italy.
FAU - Minoia, Carla
AU  - Minoia C
AD  - Hematology Unit, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy.
FAU - Murru, Roberta
AU  - Murru R
AUID- ORCID: 0000-0001-9792-9542
AD  - Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, 
      ARNAS G. Brotzu, 09134 Cagliari, Italy.
FAU - Sportoletti, Paolo
AU  - Sportoletti P
AUID- ORCID: 0000-0002-5630-9862
AD  - Sezione di Ematologia, Universita degli Studi di Perugia, 06123 Perugia, Italy.
FAU - Frigeri, Ferdinando
AU  - Frigeri F
AD  - AORN "Sant'Anna e San Sebastiano", 81100 Caserta, Italy.
FAU - Albano, Francesco
AU  - Albano F
AUID- ORCID: 0000-0001-7926-6052
AD  - 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.
FAU - Di Renzo, Nicola
AU  - Di Renzo N
AD  - UOC Ematologia e Trapianto di Cellule Staminali-PO "Vito Fazzi" ASL Lecce, 73100 
      Lecce, Italy.
FAU - Sanna, Alessandro
AU  - Sanna A
AD  - AOU Careggi, 50121 Firenze, Italy.
FAU - Laurenti, Luca
AU  - Laurenti L
AUID- ORCID: 0000-0002-8327-1396
AD  - Policlinico A. Gemelli, 00168 Roma, Italy.
FAU - Massaia, Massimo
AU  - Massaia M
AD  - SC Ematologia-AO S. Croce e Carle, 12100 Cuneo, Italy.
AD  - Dipartimento di Biotecnologie Molecolari e Scienze per la Salute, Universita 
      degli Studi di Torino, 10124 Torino, Italy.
FAU - Cassin, Ramona
AU  - Cassin R
AD  - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico of Milan, 20122 Milano, 
      Italy.
FAU - Coscia, Marta
AU  - Coscia M
AUID- ORCID: 0000-0003-2123-7675
AD  - Dipartimento di Biotecnologie Molecolari e Scienze per la Salute, Universita 
      degli Studi di Torino, 10124 Torino, Italy.
AD  - SC Ematologia U, AOU Citta della Salute e della Scienza di Torino, 10126 Torino, 
      Italy.
FAU - Patti, Caterina
AU  - Patti C
AD  - UOC Oncoematologia, Ospedali Riuniti Villa Sofia-Cervello, 90146 Palermo, Italy.
FAU - Pennese, Elsa
AU  - Pennese E
AD  - UOC Ematologia Clinica, ASL Pescara, 65124 Pescara, Italy.
FAU - Tafuri, Agostino
AU  - Tafuri A
AD  - Ematologia, AOU Sant'Andrea, Sapienza Universita di Roma, 00185 Roma, Italy.
FAU - Chiarenza, Annalisa
AU  - Chiarenza A
AD  - UOC Ematologia, AOU Policlinico G.Rodolico-San Marco, 95123 Catania, Italy.
FAU - Galieni, Piero
AU  - Galieni P
AD  - UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni, 63100 Ascoli Piceno, Italy.
FAU - Perbellini, Omar
AU  - Perbellini O
AD  - UOC Ematologia, Azienda ULSS 8 Berica, 36100 Vicenza, Italy.
FAU - Selleri, Carmine
AU  - Selleri C
AUID- ORCID: 0000-0002-5861-8984
AD  - Hematology and Bone Marrow Transplant Center, Department of Medicine and Surgery, 
      University of Salerno, 84081 Salerno, Italy.
FAU - Califano, Catello
AU  - Califano C
AD  - UOC Ematologia, PO Andrea Tortora-Pagani, 84016 Pagani, Italy.
FAU - Ferrara, Felicetto
AU  - Ferrara F
AD  - AORN Antonio Cardarelli, 80131 Napoli, Italy.
FAU - Cuneo, Antonio
AU  - Cuneo A
AUID- ORCID: 0000-0003-2001-1308
AD  - Department of Medical Science, Universita degli Studi di Ferrara, 44121 Ferrara, 
      Italy.
FAU - Murineddu, Marco
AU  - Murineddu M
AD  - Ematologia, Ospedale San Francesco ASL Nuoro, 08100 Nuoro, Italy.
FAU - Palumbo, Gaetano
AU  - Palumbo G
AD  - SC Ematologia, AOU Policlinico Foggia, 71122 Foggia, Italy.
FAU - Scortechini, Ilaria
AU  - Scortechini I
AD  - Azienda Ospedaliero Universitaria delle Marche, 60126 Ancona, Italy.
FAU - Tedeschi, Alessandra
AU  - Tedeschi A
AD  - Divisione di Ematologia, ASST GOM Niguarda, 20162 Milano, Italy.
FAU - Trentin, Livio
AU  - Trentin L
AUID- ORCID: 0000-0003-1222-6149
AD  - Dipartimento di Medicina, UOC Ematologia, Universita di Padova, 35122 Padova, 
      Italy.
FAU - Varettoni, Marzia
AU  - Varettoni M
AUID- ORCID: 0000-0001-7304-1629
AD  - Divisione di Ematologia, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, 
      Italy.
FAU - Pane, Fabrizio
AU  - Pane F
AUID- ORCID: 0000-0003-2563-4125
AD  - Division of Hematology, Department of Clinical Medicine and Surgery, Universita 
      di Napoli Federico II, 80131 Napoli, Italy.
FAU - Liberati, Anna Marina
AU  - Liberati AM
AUID- ORCID: 0000-0002-3686-3188
AD  - AO Santa Maria, Universita degli Studi Di Perugia, 05100 Terni, Italy.
FAU - Merli, Francesco
AU  - Merli F
AD  - Ematologia AUSL-IRCCS Reggio Emilia, 42123 Reggio Emilia, Italy.
FAU - Morello, Lucia
AU  - Morello L
AD  - IRCCS Humanitas Research Hospital-Humanitas Cancer Center, 20089 Rozzano, Italy.
FAU - Musuraca, Gerardo
AU  - Musuraca G
AUID- ORCID: 0000-0003-1947-1032
AD  - IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014 
      Meldola, Italy.
FAU - Tani, Monica
AU  - Tani M
AD  - Haematology Unit, Ospedale S. Maria delle Croci, 48121 Ravenna, Italy.
FAU - Ibatici, Adalberto
AU  - Ibatici A
AD  - IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy.
FAU - Regazzoni, Giulia
AU  - Regazzoni G
AD  - Johnson & Johnson Innovative Medicine, 20126 Milano, Italy.
FAU - Di Candia, Michele
AU  - Di Candia M
AD  - Johnson & Johnson Innovative Medicine, 20126 Milano, Italy.
FAU - Palma, Maria
AU  - Palma M
AD  - Johnson & Johnson Innovative Medicine, 20126 Milano, Italy.
FAU - Arienti, Danilo
AU  - Arienti D
AD  - Johnson & Johnson Innovative Medicine, 20126 Milano, Italy.
FAU - Molica, Stefano
AU  - Molica S
AUID- ORCID: 0000-0003-2795-6507
AD  - Dipartimento Onco-Ematologico, Azienda Ospedaliera Pugliese-Ciaccio, 88100 
      Catanzaro, Italy.
AD  - Queens Centre for Oncology and Haematology, Castle Hill Hospital, Hull University 
      NHS Trust, Hull HU16 5JQ, UK.
LA  - eng
GR  - N/A/Johnson & Johnson/
PT  - Journal Article
DEP - 20240320
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC10969011
OTO - NOTNLM
OT  - chronic lymphocytic leukemia
OT  - clinical outcomes
OT  - effectiveness
OT  - ibrutinib
OT  - real-world evidence
OT  - retention
COIS- A. Cuneo has received honoraria for speaking from AbbVie, AstraZeneca, BeiGene, 
      and Janssen; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, 
      Janssen, and Lilly. A. Tedeschi has received honoraria for speaking from 
      AstraZeneca, Lilly, AbbVie, BeiGene, and Janssen; and has served on advisory 
      boards for AstraZeneca, Lilly, AbbVie, BeiGene, and Janssen. F. Frigeri has 
      received honoraria for speaking and served on the advisory board for Celgene, 
      Janssen-Cilag, BMS, GSK, AbbVie, Eusapharma, Novartis, AstraZeneca, Sobi, Incyte, 
      and Gilead. F.M. has served on advisory boards for Takeda, Janssen, Novartis, 
      Gilead, Incyte, and Roche. F.R.M. has received research grants from AbbVie and 
      Takeda; has received honoraria for speaking from Janssen, AbbVie, Astra Zeneca, 
      and BeiGene; has served on advisory boards for AbbVie, BeiGene, AstraZeneca, and 
      Janssen; and has served as a consultant for Janssen, AbbVie, AstraZeneca, and 
      BeiGene. G.M. has received honoraria for speaking from Janssen, AbbVie, 
      AstraZeneca, Incyte, and Takeda; and has served on advisory boards for Janssen, 
      AbbVie, AstraZeneca, Incyte, and Takeda. L.S. has received honoraria for speaking 
      from Octapharma; and has served on advisory boards for AbbVie, AstraZeneca, 
      BeiGene, Janssen, and Lilly. L.T. has served on advisory boards for BeiGene, 
      Janssen, and Takeda. M.C. has received research grants from Janssen and AbbVie; 
      has received honoraria for speaking from AstraZeneca; and has served on advisory 
      boards for AbbVie, AstraZeneca, BeiGene, and Janssen. M. Massaia has received 
      research grants from Sanofi and has served on advisory boards for AbbVie and 
      Janssen. M.V. has received honoraria for speaking from AbbVie, AstraZeneca, and 
      BeiGene; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, and 
      Janssen. P.S. has received research grants from Gilead; has received honoraria 
      for speaking from Janssen, AstraZeneca, and AbbVie; has served on advisory boards 
      for Janssen, AstraZeneca, AbbVie, and BeiGene. R.M. has received honoraria for 
      speaking from AbbVie, AstraZeneca, BeiGene, and Janssen; and has served on 
      advisory boards for AstraZeneca and BeiGene. S.M. has received honoraria for 
      speaking from AstraZeneca and AbbVie; and has served as consultant for Janssen 
      and AstraZeneca. D.A., G.R., M.D.C., and M.P. are currently employed at Johnson & 
      Johnson. A. Chiarenza, A.I., A.M.L., A.S., A. Tafuri, C.C., C.M., C.P., C.S., 
      E.P., F.A., F. Ferrara, F.P., G.P., I.S., L.L., L.M., M. Murineddu, M.T., N.D.R., 
      O.P., P.G., P.R.S. and R.C. declare no conflict of interest.
EDAT- 2024/03/28 06:44
MHDA- 2024/03/28 06:45
PMCR- 2024/03/20
CRDT- 2024/03/28 01:02
PHST- 2024/01/21 00:00 [received]
PHST- 2024/03/07 00:00 [revised]
PHST- 2024/03/15 00:00 [accepted]
PHST- 2024/03/28 06:45 [medline]
PHST- 2024/03/28 06:44 [pubmed]
PHST- 2024/03/28 01:02 [entrez]
PHST- 2024/03/20 00:00 [pmc-release]
AID - cancers16061228 [pii]
AID - cancers-16-01228 [pii]
AID - 10.3390/cancers16061228 [doi]
PST - epublish
SO  - Cancers (Basel). 2024 Mar 20;16(6):1228. doi: 10.3390/cancers16061228.