Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data

Autor: Tombak A; Mersin University Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Mersin, Turkey, Pepedil Tanrıkulu F; Başkent University Adana Application and Research Center, Adana, Turkey, Durusoy SS; Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, Turkey, Dinçyürek HD; Çukurova University Faculty of Medicine, Department of Hematology, Adana, Turkey, Kaya E; İnönü University Turgut Özal Medical Center, Department of Hematology, Malatya, Turkey, Ümit EG; Trakya University Faculty of Medicine, Department of Hematology, Edirne, Turkey, Yavaşoğlu İ; Adnan Menderes Univercity Faculty of Medicine, Department of Hematology, Aydın, Turkey, Mehtap Ö; Kocaeli University Faculty of Medicine,Department of Hematology, Kocaeli, Turkey, Deveci B; Medstar Antalya Hospital, Clinic of Hematology, Antalya, Turkey, Özcan MA; Dokuz Eylül University Faculty of Medicine, Department of Hematology, İzmir, Turkey, Terzi H; Cumhuriyet University Faculty of Medicine, Department of Hematology, Sivas, Turkey, Okay M; Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ankara, Turkey, Sayınalp N; Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ankara, Turkey, Yılmaz M; Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, Turkey, Okan V; Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, Turkey, Kızıklı A; Gaziantep University Faculty of Medicine, Department of Hematology, Gaziantep, Turkey, Özcan Ö; Bezmialem Vakıf University Faculty of Medicine, Department of Hematology, İstanbul, Turkey, Çetin G; Bezmialem Vakıf University Faculty of Medicine, Department of Hematology, İstanbul, Turkey, Demircioğlu S; Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, Konya, Turkey, Aydoğdu İ; Celal Bayar University Faculty of Medicine, Department of Hematology, Manisa, Turkey, Saydam G; Ege University Hospital, Clinic of Internal Medicine, Division of Hematology İzmir, Turkey, Davulcu EA; Ege University Hospital, Clinic of Internal Medicine, Division of Hematology İzmir, Turkey, İlhan G; Mustafa Kemal University Faculty of Medicine, Department of Internal Medicine, Hatay, Turkey, Uçar MA; Ankara Numune Training and Research Hospital, Clinic of Hematology, Ankara, Turkey, Özet G; Ankara Numune Training and Research Hospital, Clinic of Hematology, Ankara, Turkey, Akpınar S; Namık Kemal University Faculty of Medicine, Department of Hematology, Tekirdağ, Turkey, Turgut B; Namık Kemal University Faculty of Medicine, Department of Hematology, Tekirdağ, Turkey, Berber İ; İnönü University Turgut Özal Medical Center, Department of Hematology, Malatya, Turkey, Kurtoğlu E; Antalya Training and Research Hospital, Clinic of Hematology, Antalya, Turkey, Sönmez M; Karadeniz Technical University Faculty of Medicine, Department of Hematology, Trabzon, Turkey, Batur DS; Karadeniz Technical University Faculty of Medicine, Department of Hematology, Trabzon, Turkey, Yıldırım R; Ataturk University Faculty of Medicine, Department of Hematology, Erzurum, Turkey, Özkocamaz V; Uludağ University Faculty of Medicine, Division of Hematology, Bursa, Turkey, Güneş AK; Şanlıurfa Mehmet Akif İnan Training and Research Hospital, Clinic of Hematology, Şanlıurfa, Turkey, Sahip B; Zonguldak Bülent Ecevit University Faculty of Medicine, Department of Hematology, Zonguldak, Turkey, Ertop Ş; Zonguldak Bülent Ecevit University Faculty of Medicine, Department of Hematology, Zonguldak, Turkey, Akay OM; Koç University Faculty of Medicine, Department of Hematology, İstanbul, Turkey, Baştürk A; Konya Training and Research Hospital, Clinic of Internal Medicine, Konya, Turkey, Doğu MH; İstanbul Training and Research Hospital, Clinic of Hematology, İstanbul, Turkey, Akdeniz A; Mersin University Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Mersin, Turkey, Ünal A; Erciyes University Faculty of Medicine, Department of Internal Medicine, Kayseri, Turkey, Seyhanlı A; Ege University Faculty of Medicine, Department of Hematology, İzmir, Turkey, Gürkan E; Çukurova University Faculty of Medicine, Department of Hematology, Adana, Turkey, Çekdemir D; Anadolu Medical Center, Bone Marrow Transplantation Center, Department of Hematology, Kocaeli, Turkey, Ferhanoğlu B; İstanbul University-Cerrahpaşa Cerrahpaşa Faculty of Medicine, Department of Internal Medicine Section of Haematology, İstanbul, Turkey
Jazyk: angličtina
Zdroj: Turkish journal of haematology : official journal of Turkish Society of Haematology [Turk J Haematol] 2021 Dec 07; Vol. 38 (4), pp. 273-285. Date of Electronic Publication: 2021 Aug 27.
DOI: 10.4274/tjh.galenos.2021.2021.0007
Abstrakt: 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.
Databáze: MEDLINE
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