PMID- 31184241
OWN - NLM
STAT- MEDLINE
DCOM- 20200910
LR  - 20211204
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 60
IP  - 12
DP  - 2019 Dec
TI  - Safety and efficacy analysis of long-term follow up real-world data with 
      ibrutinib monotherapy in 58 patients with CLL treated in a single-center in 
      Greece.
PG  - 2939-2945
LID - 10.1080/10428194.2019.1620944 [doi]
AB  - Ibrutinib (IB) revealed high efficacy and safety profile in phase 2/3 chronic 
      lymphocytic clinical trials. Emerging real-world-data shows similar response and 
      survival, but higher discontinuation rates due to adverse events (AEs). We 
      present retrospective real-world data from 58 chronic lymphocytic leukemia (CLL) 
      patients (August 2014-January 2019) treated with IB monotherapy, according to 
      standard instructions, in a Greek single-center, focusing on safety and efficacy. 
      Eleven untreated first line (1st L) and 47 relapsed/refractory(R/R) CLL patients 
      received IB for 6.6(0.7-46.8) and 16.3(0.4-53.7) months, respectively. Nine 
      percent of 1stL and 10.6% of R/R patients discontinued IB due to AEs. Atrial 
      fibrillation (AF) was the most common discontinuation AE cause (3.5% of 
      patients). Thirteen patients (24.5%) discontinued due to disease progression: 6 
      Richter transformation (RT) cases, after 10.6 months (1-35.9) and 7 
      CLL-progression cases, after 30.3 months (5.4-43.4) of IB initiation. IB had 
      minimal impact on immunoglobulin G (IgG)-levels, CLL-related autoimmunity, and 
      second primary malignancies (SPM). Our real-world data show that CLL patients 
      present similar to clinical trials' outcomes if treated homogenously according to 
      standard guidelines, resulting in fewer unneeded discontinuations and shrinkage 
      of treatment armamentarium.
FAU - Dimou, Maria
AU  - Dimou M
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Iliakis, Theodoros
AU  - Iliakis T
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Pardalis, Vasileios
AU  - Pardalis V
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Bitsani, Catherin
AU  - Bitsani C
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Vassilakopoulos, Theodoros P
AU  - Vassilakopoulos TP
AD  - Department of Haematology, National and Kapodistrian University of Athens, 
      Athens, Greece.
FAU - Angelopoulou, Maria
AU  - Angelopoulou M
AD  - Department of Haematology, National and Kapodistrian University of Athens, 
      Athens, Greece.
FAU - Tsaftaridis, Panayiotis
AU  - Tsaftaridis P
AD  - Department of Haematology, National and Kapodistrian University of Athens, 
      Athens, Greece.
FAU - Papaioannou, Paraskevi
AU  - Papaioannou P
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Koudouna, Aspasia
AU  - Koudouna A
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Kalyva, Sotiria
AU  - Kalyva S
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Kyrtsonis, Marie-Christine
AU  - Kyrtsonis MC
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Panayiotidis, Panayiotis
AU  - Panayiotidis P
AD  - First Propedeutic Department of Internal Medicine, Hematology Unit, Laikon 
      General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
LA  - eng
PT  - Journal Article
DEP - 20190611
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Piperidines)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyrimidines)
RN  - 1X70OSD4VX (ibrutinib)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/analogs & derivatives
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Comorbidity
MH  - Disease Progression
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis/*drug therapy/etiology/mortality
MH  - Male
MH  - Piperidines
MH  - Prognosis
MH  - Protein Kinase Inhibitors/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Pyrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Pyrimidines/administration & dosage/adverse effects/*therapeutic use
MH  - Recurrence
MH  - Retreatment
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Ibrutinib
OT  - adverse events
OT  - autoimmunity
OT  - chronic lymphocytic leukemia
OT  - hypogammaglobulinemia
OT  - real-world data
EDAT- 2019/06/12 06:00
MHDA- 2020/09/12 06:00
CRDT- 2019/06/12 06:00
PHST- 2019/06/12 06:00 [pubmed]
PHST- 2020/09/12 06:00 [medline]
PHST- 2019/06/12 06:00 [entrez]
AID - 10.1080/10428194.2019.1620944 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2019 Dec;60(12):2939-2945. doi: 10.1080/10428194.2019.1620944. 
      Epub 2019 Jun 11.