TY  - JOUR
TI  - Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic
Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data
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.
AU  - GÜNEŞ, Ahmet Kürşad
AU  - ÖZKOCAMAZ, Vildan
AU  - AKAY, Olga Meltem
AU  - ERTOP, Şehmus
AU  - SAHİP, Birsen
AU  - Ferhanoğlu, Burhan
AU  - ÇEKDEMIR, DEMET
AU  - OKAN, Vahap
AU  - GURKAN, EMEL
AU  - YAVAŞOĞLU, İrfan
AU  - Dinçyürek, Hüseyin Derya
AU  - DURUSOY, Salih Sertaç
AU  - YILMAZ, MEHMET
AU  - AKDENİZ, Aydan
AU  - TANRIKULU, Funda Pepedil
AU  - KIZIKLI, Alperen
AU  - Sayınalp, Nilgün
AU  - TOMBAK, ANIL
AU  - SELİM BATUR, Derya
AU  - BAŞTÜRK, Abdülkadir
AU  - deveci, BURAK
AU  - MEHTAP, Özgür
AU  - Çetin, Güven
AU  - ÖZCAN, MEHMET ALİ
AU  - ÜMİT, Elif Gülsüm
AU  - KAYA, Emin
AU  - Terzi, Hatice
AU  - DOĞU, Mehmet Hilmi
AU  - YILDIRIM, Rahşan
AU  - SEYHANLI, Ahmet
AU  - Demircioğlu, Sinan
AU  - ÜNAL, Ali
AU  - ÖZCAN, Ömer
AU  - SAYDAM, Güray
AU  - ARSLAN DAVULCU, EREN
AU  - AYDOGDU, ISMET
AU  - UÇAR, Mehmet Ali
AU  - OKAY, Müfide
AU  - ILHAN, GÜL
DO  - 10.4274/tjh.galenos.2021.2021.0007
PY  - 2021
JO  - Turkish Journal of Hematology
VL  - 38
IS  - 4
SN  - 1300-7777
SP  - 273
EP  - 285
DB  - TRDizin
UR  - http://search/yayin/detay/508839
ER  -