PMID- 34448556
OWN - NLM
STAT- MEDLINE
DCOM- 20220316
LR  - 20220316
IS  - 1308-5263 (Electronic)
IS  - 1300-7777 (Print)
IS  - 1300-7777 (Linking)
VI  - 38
IP  - 4
DP  - 2021 Dec 7
TI  - Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic 
      Leukemia: Retrospective Analysis of Real-Life Data.
PG  - 273-285
LID - 10.4274/tjh.galenos.2021.2021.0007 [doi]
AB  - OBJECTIVE: This study aimed to retrospectively evaluate the efficacy, safety, and 
      survival outcome of single-agent ibrutinib therapy in chronic lymphocytic 
      leukemia patients. MATERIALS AND METHODS: A total of 136 patients (mean age +/- 
      standard deviation: 64.6+/-10.3 years, 66.9% males) who had received at least one 
      dose of ibrutinib were included in this retrospective multicenter, 
      noninterventional hospital-registry study conducted at 33 centers across Turkey. 
      Data on patient demographics, baseline characteristics, laboratory findings, and 
      leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome 
      including overall survival (OS) and progression-free survival (PFS), and safety 
      data were analyzed. RESULTS: Overall, 36.7% of patients were categorized as 
      Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai 
      stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 
      39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of 
      pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 
      months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while 
      median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 
      20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment 
      response (complete or partial response), PFS time, and OS time were better with 
      0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, 
      respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and 
      p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and 
      p=0.002, respectively). No significant difference was noted in treatment response 
      rates or survival outcome with respect to the presence of comorbidity, bulky 
      disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) 
      patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), 
      neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5). 
      CONCLUSION: This real-life analysis confirms the favorable efficacy and safety 
      profile of long-term ibrutinib treatment while emphasizing the potential adverse 
      impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, 
      and advanced Rai stage on patient compliance, treatment response, and survival 
      outcomes.
FAU - Tombak, Anil
AU  - Tombak A
AUID- ORCID: 0000-0002-7195-1845
AD  - Mersin University Faculty of Medicine, Department of Internal Medicine, Division 
      of Hematology, Mersin, Turkey
FAU - Pepedil Tanrikulu, Funda
AU  - Pepedil Tanrikulu F
AUID- ORCID: 0000-0003-1878-1872
AD  - Baskent University Adana Application and Research Center, Adana, Turkey
FAU - Durusoy, Salih Sertac
AU  - Durusoy SS
AUID- ORCID: 0000-0002-3577-6330
AD  - Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, 
      Turkey
FAU - Dincyurek, Huseyin Derya
AU  - Dincyurek HD
AD  - Cukurova University Faculty of Medicine, Department of Hematology, Adana, Turkey
FAU - Kaya, Emin
AU  - Kaya E
AUID- ORCID: 0000-0001-8605-8497
AD  - Inonu University Turgut Ozal Medical Center, Department of Hematology, Malatya, 
      Turkey
FAU - Umit, Elif Gulsum
AU  - Umit EG
AUID- ORCID: 0000-0001-5589-3000
AD  - Trakya University Faculty of Medicine, Department of Hematology, Edirne, Turkey
FAU - Yavasoglu, Irfan
AU  - Yavasoglu I
AUID- ORCID: 0000-0003-1703-2175
AD  - Adnan Menderes Univercity Faculty of Medicine, Department of Hematology, Aydin, 
      Turkey
FAU - Mehtap, Ozgur
AU  - Mehtap O
AD  - Kocaeli University Faculty of Medicine,Department of Hematology, Kocaeli, Turkey
FAU - Deveci, Burak
AU  - Deveci B
AD  - Medstar Antalya Hospital, Clinic of Hematology, Antalya, Turkey
FAU - Ozcan, Mehmet Ali
AU  - Ozcan MA
AD  - Dokuz Eylul University Faculty of Medicine, Department of Hematology, Izmir, 
      Turkey
FAU - Terzi, Hatice
AU  - Terzi H
AD  - Cumhuriyet University Faculty of Medicine, Department of Hematology, Sivas, 
      Turkey
FAU - Okay, Mufide
AU  - Okay M
AUID- ORCID: 0000-0001-5317-0597
AD  - Hacettepe University Faculty of Medicine, Department of Internal Medicine, 
      Division of Hematology, Ankara, Turkey
FAU - Sayinalp, Nilgun
AU  - Sayinalp N
AD  - Hacettepe University Faculty of Medicine, Department of Internal Medicine, 
      Division of Hematology, Ankara, Turkey
FAU - Yilmaz, Mehmet
AU  - Yilmaz M
AD  - Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, 
      Turkey
FAU - Okan, Vahap
AU  - Okan V
AUID- ORCID: 0000-0002-9869-8181
AD  - Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, 
      Turkey
FAU - Kizikli, Alperen
AU  - Kizikli A
AUID- ORCID: 0000-0002-6840-4197
AD  - Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, 
      Turkey
FAU - Ozcan, Omer
AU  - Ozcan O
AUID- ORCID: 0000-0003-2050-2588
AD  - Bezmialem Vakif University Faculty of Medicine, Department of Hematology, 
      Istanbul, Turkey
FAU - Cetin, Guven
AU  - Cetin G
AD  - Bezmialem Vakif University Faculty of Medicine, Department of Hematology, 
      Istanbul, Turkey
FAU - Demircioglu, Sinan
AU  - Demircioglu S
AUID- ORCID: 0000-0003-1277-5105
AD  - Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, 
      Konya, Turkey
FAU - Aydogdu, Ismet
AU  - Aydogdu I
AD  - Celal Bayar University Faculty of Medicine, Department of Hematology, Manisa, 
      Turkey
FAU - Saydam, Guray
AU  - Saydam G
AD  - Ege University Hospital, Clinic of Internal Medicine, Division of Hematology 
      Izmir, Turkey
FAU - Davulcu, Eren Arslan
AU  - Davulcu EA
AUID- ORCID: 0000-0001-9262-2883
AD  - Ege University Hospital, Clinic of Internal Medicine, Division of Hematology 
      Izmir, Turkey
FAU - Ilhan, Gul
AU  - Ilhan G
AD  - Mustafa Kemal University Faculty of Medicine, Department of Internal Medicine, 
      Hatay, Turkey
FAU - Ucar, Mehmet Ali
AU  - Ucar MA
AUID- ORCID: 0000-0002-6041-7364
AD  - Ankara Numune Training and Research Hospital, Clinic of Hematology, Ankara, 
      Turkey
FAU - Ozet, Gulsum
AU  - Ozet G
AD  - Ankara Numune Training and Research Hospital, Clinic of Hematology, Ankara, 
      Turkey
FAU - Akpinar, Seval
AU  - Akpinar S
AUID- ORCID: 0000-0002-6961-8971
AD  - Namik Kemal University Faculty of Medicine, Department of Hematology, Tekirdag, 
      Turkey
FAU - Turgut, Burhan
AU  - Turgut B
AD  - Namik Kemal University Faculty of Medicine, Department of Hematology, Tekirdag, 
      Turkey
FAU - Berber, Ilhami
AU  - Berber I
AD  - Inonu University Turgut Ozal Medical Center, Department of Hematology, Malatya, 
      Turkey
FAU - Kurtoglu, Erdal
AU  - Kurtoglu E
AD  - Antalya Training and Research Hospital, Clinic of Hematology, Antalya, Turkey
FAU - Sonmez, Mehmet
AU  - Sonmez M
AUID- ORCID: 0000-0003-3127-666X
AD  - Karadeniz Technical University Faculty of Medicine, Department of Hematology, 
      Trabzon, Turkey
FAU - Batur, Derya Selim
AU  - Batur DS
AUID- ORCID: 0000-0002-5345-3914
AD  - Karadeniz Technical University Faculty of Medicine, Department of Hematology, 
      Trabzon, Turkey
FAU - Yildirim, Rahsan
AU  - Yildirim R
AD  - Ataturk University Faculty of Medicine, Department of Hematology, Erzurum, Turkey
FAU - Ozkocamaz, Vildan
AU  - Ozkocamaz V
AUID- ORCID: 0000-0003-0014-7398
AD  - Uludag University Faculty of Medicine, Division of Hematology, Bursa, Turkey
FAU - Gunes, Ahmet Kursad
AU  - Gunes AK
AD  - Sanliurfa Mehmet Akif Inan Training and Research Hospital, Clinic of Hematology, 
      Sanliurfa, Turkey
FAU - Sahip, Birsen
AU  - Sahip B
AUID- ORCID: 0000-0003-0014-7398
AD  - Zonguldak Bulent Ecevit University Faculty of Medicine, Department of Hematology, 
      Zonguldak, Turkey
FAU - Ertop, Sehmus
AU  - Ertop S
AUID- ORCID: 0000-0001-8771-7343
AD  - Zonguldak Bulent Ecevit University Faculty of Medicine, Department of Hematology, 
      Zonguldak, Turkey
FAU - Akay, Olga Meltem
AU  - Akay OM
AUID- ORCID: 0000-0002-6759-1939
AD  - Koc University Faculty of Medicine, Department of Hematology, Istanbul, Turkey
FAU - Basturk, Abdulkadir
AU  - Basturk A
AD  - Konya Training and Research Hospital, Clinic of Internal Medicine, Konya, Turkey
FAU - Dogu, Mehmet Hilmi
AU  - Dogu MH
AUID- ORCID: 0000-0001-7237-2637
AD  - Istanbul Training and Research Hospital, Clinic of Hematology, Istanbul, Turkey
FAU - Akdeniz, Aydan
AU  - Akdeniz A
AUID- ORCID: 0000-0002-5160-4803
AD  - Mersin University Faculty of Medicine, Department of Internal Medicine, Division 
      of Hematology, Mersin, Turkey
FAU - Unal, Ali
AU  - Unal A
AUID- ORCID: 0000-0002-0089-2841
AD  - Erciyes University Faculty of Medicine, Department of Internal Medicine, Kayseri, 
      Turkey
FAU - Seyhanli, Ahmet
AU  - Seyhanli A
AUID- ORCID: 0000-0001-6082-2995
AD  - Ege University Faculty of Medicine, Department of Hematology, Izmir, Turkey
FAU - Gurkan, Emel
AU  - Gurkan E
AD  - Cukurova University Faculty of Medicine, Department of Hematology, Adana, Turkey
FAU - Cekdemir, Demet
AU  - Cekdemir D
AUID- ORCID: 0000-0002-1881-5166
AD  - Anadolu Medical Center, Bone Marrow Transplantation Center, Department of 
      Hematology, Kocaeli, Turkey
FAU - Ferhanoglu, Burhan
AU  - Ferhanoglu B
AUID- ORCID: 0000-0002-4257-549X
AD  - Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of 
      Internal Medicine Section of Haematology, Istanbul, Turkey
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210827
PL  - Turkey
TA  - Turk J Haematol
JT  - Turkish journal of haematology : official journal of Turkish Society of 
      Haematology
JID - 9606065
RN  - 0 (Piperidines)
RN  - 1X70OSD4VX (ibrutinib)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/adverse effects/*analogs & derivatives
MH  - Aged
MH  - Female
MH  - Humans
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
MH  - Male
MH  - Middle Aged
MH  - *Piperidines/adverse effects
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Turkey
PMC - PMC8656120
OTO - NOTNLM
OT  - Chronic lymphocytic leukemia
OT  - Ibrutinib
OT  - Bruton's tyrosinekinase inhibitor
COIS- Conflict of Interest: No conflict of interest was declared by the authors.
EDAT- 2021/08/28 06:00
MHDA- 2022/03/17 06:00
PMCR- 2021/12/01
CRDT- 2021/08/27 09:28
PHST- 2021/08/27 09:28 [entrez]
PHST- 2021/08/28 06:00 [pubmed]
PHST- 2022/03/17 06:00 [medline]
PHST- 2021/12/01 00:00 [pmc-release]
AID - 49973 [pii]
AID - 10.4274/tjh.galenos.2021.2021.0007 [doi]
PST - ppublish
SO  - Turk J Haematol. 2021 Dec 7;38(4):273-285. doi: 
      10.4274/tjh.galenos.2021.2021.0007. Epub 2021 Aug 27.