PMID- 36837525
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230228
IS  - 1648-9144 (Electronic)
IS  - 1010-660X (Print)
IS  - 1010-660X (Linking)
VI  - 59
IP  - 2
DP  - 2023 Feb 9
TI  - Real-World Clinical Outcomes and Adverse Events in Patients with Chronic 
      Lymphocytic Leukemia Treated with Ibrutinib: A Single-Center Retrospective Study.
LID - 10.3390/medicina59020324 [doi]
LID - 324
AB  - Background and Objectives: The treatment of chronic lymphocytic leukemia (CLL) 
      has acquired new targeted therapies. In clinical trials, ibrutinib improved 
      outcomes safely. Real-world data called for a reappraisal of ibrutinib 
      strategies. We report on a single center's experience with ibrutinib monotherapy, 
      aiming to explore the outcomes, tolerability, and prognosis of CLL patients in 
      routine clinical practice. Materials and Methods: Data were collected from all 
      CLL patients treated with ibrutinib at Fundeni Clinical Institute, Bucharest, 
      Romania, between January 2016 and June 2021. Results: A total of one hundred 
      twenty-three CLL adult patients were treated with ibrutinib. Of the patients, 87% 
      had relapsed/refractory CLL. The median age at ibrutinib initiation was 65 years; 
      44.7% of patients were staged Rai III/IV. At 32-month median follow-up, the 
      median progression-free survival (PFS) was 50 months, the overall survival (OS) 
      was not reached, and the overall response rate (ORR) was 86.2%. The age or number 
      of previous therapies did not impact outcomes or tolerability. An Eastern 
      Cooperative Oncology Group performance status (ECOG PS) score >/= 2 and shorter 
      time from initiation of last therapy (TILT) before ibrutinib predicted inferior 
      PFS. Baseline characteristics had no impact on the OS except for TILT in R/R CLL 
      patients. Drug-related adverse events (AEs) of any grade and grade >/= 3 AEs were 
      reported in 82.1% and 30.9% of the patients, respectively. Infections were the 
      most common AEs (29.3%). Drug discontinuation was permanent in 43.9% of patients, 
      mainly due to disease progression (17.1%) and toxicity (8.9%). Patients with a 
      Cumulative Illness Rating Scale (CIRS) score >/= 6 had a higher risk for 
      toxicity-related discontinuation. An ECOG PS >/= 2 predicted an increased rate of 
      permanent discontinuation and grade >/= 3 AEs. Conclusions: The outcomes of this 
      study align with the results from ibrutinib clinical trials. Our study 
      demonstrated that poor patient fitness, early relapse before ibrutinib, and 
      permanent ibrutinib discontinuation are essential outcome determinants. Patient 
      comorbidity burden and fitness were significant predictors for ibrutinib 
      intolerance.
FAU - Moldovianu, Ana-Maria
AU  - Moldovianu AM
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
AD  - Department of Hematology, University of Medicine and Pharmacy "Carol Davila", 
      050474 Bucharest, Romania.
FAU - Stoia, Razvan
AU  - Stoia R
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Vasilica, Mariana
AU  - Vasilica M
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Ursuleac, Iulia
AU  - Ursuleac I
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
AD  - Department of Hematology, University of Medicine and Pharmacy "Carol Davila", 
      050474 Bucharest, Romania.
FAU - Badelita, Sorina Nicoleta
AU  - Badelita SN
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Tomescu, Andra Alina
AU  - Tomescu AA
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Preda, Oana Diana
AU  - Preda OD
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Bardas, Alexandru
AU  - Bardas A
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
FAU - Cirstea, Mihaela
AU  - Cirstea M
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
AD  - Department of Hematology, University of Medicine and Pharmacy "Carol Davila", 
      050474 Bucharest, Romania.
FAU - Coriu, Daniel
AU  - Coriu D
AD  - Department of Hematology and Bone Marrow Transplant, Fundeni Clinical Institute, 
      022328 Bucharest, Romania.
AD  - Department of Hematology, University of Medicine and Pharmacy "Carol Davila", 
      050474 Bucharest, Romania.
LA  - eng
PT  - Journal Article
DEP - 20230209
PL  - Switzerland
TA  - Medicina (Kaunas)
JT  - Medicina (Kaunas, Lithuania)
JID - 9425208
RN  - 1X70OSD4VX (ibrutinib)
RN  - JAC85A2161 (Adenine)
RN  - 0 (Piperidines)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Aged
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
MH  - Retrospective Studies
MH  - Adenine/therapeutic use
MH  - Piperidines/therapeutic use
PMC - PMC9959500
OTO - NOTNLM
OT  - Bruton tyrosine kinase inhibitor
OT  - adverse events
OT  - chronic lymphocytic leukemia (CLL)
OT  - ibrutinib
OT  - real-world
COIS- The authors declare no conflict of interest.
EDAT- 2023/02/26 06:00
MHDA- 2023/03/03 06:00
PMCR- 2023/02/09
CRDT- 2023/02/25 03:33
PHST- 2022/12/21 00:00 [received]
PHST- 2023/01/28 00:00 [revised]
PHST- 2023/02/07 00:00 [accepted]
PHST- 2023/02/25 03:33 [entrez]
PHST- 2023/02/26 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2023/02/09 00:00 [pmc-release]
AID - medicina59020324 [pii]
AID - medicina-59-00324 [pii]
AID - 10.3390/medicina59020324 [doi]
PST - epublish
SO  - Medicina (Kaunas). 2023 Feb 9;59(2):324. doi: 10.3390/medicina59020324.