Blood Res 2020; 55(4):
Published online December 31, 2020
https://doi.org/10.5045/br.2020.2020158
© The Korean Society of Hematology
Correspondence to : Mesut Göçer, M.D.
Department of Hematology, Antalya Training and Research Hospital, Antalya 07055, Turkey
E-mail: gocermesut@gmail.com
Background
Ibrutinib is an oral irreversible Bruton’s tyrosine kinase inhibitor. Here, we demonstrate the efficacy and safety of ibrutinib using real-life data from patients with marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), Waldenström macroglobulinemia (WM), and follicular lymphoma (FL), especially in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
Methods
This is a retrospective, observational, non-interventional, and single-center study on 32 patients who received ibrutinib treatment between January 2017 and March 2020 regardless of their diagnosis.
Results
Of the 32 patients, 11 had CLL and 21 had other B-cell lymphomas. Patients with CLL were prescribed ibrutinib for a median of 4 months (range, 2-18). In this group, diarrhea was observed in 3 (27.3%), pneumonia in 3 (27.3%), and thrombocytopenia and/or neutropenia in 2 (18.2%) patients. The overall response rate (ORR) was 85.6 % [28.5 % complete response (CR) and 57.1 % partial response (PR)] in the final response assessment during treatment with ibrutinib. Among other types of B-cell lymphoma, seven (33.4%) of the 21 patients were diagnosed with MCL, 5 (23.8%) with DLBCL, 4 (19.0%) with MZL, 3 (14.3%) with WM, and 2 (9.5%) with FL, upon follow-up. The median treatment duration was 4 months (range, 1-28) in this group. The most common adverse event was diarrhea: 8 (38.1%) patients. The ORR was 66.6% (20.0% CR and 46.6% PR) in the final response assessment during the treatment.
Conclusion
Ibrutinib is a good treatment option for CLL and other B-cell lymphomas, with an acceptable side effect profile, and high and promising CR/PR response rates. Ibrutinib treatment at an early stage decreases the burden of cytotoxic therapy in fragile patients, thereby, increasing their quality of life.
Keywords Ibrutinib, Bruton’s tyrosine kinase, B-cell lymphoma, Chronic lymphocytic leukemia
Blood Res 2020; 55(4): 206-212
Published online December 31, 2020 https://doi.org/10.5045/br.2020.2020158
Copyright © The Korean Society of Hematology.
Mesut Göçer, Erdal Kurtoğlu
Department of Hematology, Antalya Training and Research Hospital, Antalya, Turkey
Correspondence to:Mesut Göçer, M.D.
Department of Hematology, Antalya Training and Research Hospital, Antalya 07055, Turkey
E-mail: gocermesut@gmail.com
Background
Ibrutinib is an oral irreversible Bruton’s tyrosine kinase inhibitor. Here, we demonstrate the efficacy and safety of ibrutinib using real-life data from patients with marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), Waldenström macroglobulinemia (WM), and follicular lymphoma (FL), especially in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
Methods
This is a retrospective, observational, non-interventional, and single-center study on 32 patients who received ibrutinib treatment between January 2017 and March 2020 regardless of their diagnosis.
Results
Of the 32 patients, 11 had CLL and 21 had other B-cell lymphomas. Patients with CLL were prescribed ibrutinib for a median of 4 months (range, 2-18). In this group, diarrhea was observed in 3 (27.3%), pneumonia in 3 (27.3%), and thrombocytopenia and/or neutropenia in 2 (18.2%) patients. The overall response rate (ORR) was 85.6 % [28.5 % complete response (CR) and 57.1 % partial response (PR)] in the final response assessment during treatment with ibrutinib. Among other types of B-cell lymphoma, seven (33.4%) of the 21 patients were diagnosed with MCL, 5 (23.8%) with DLBCL, 4 (19.0%) with MZL, 3 (14.3%) with WM, and 2 (9.5%) with FL, upon follow-up. The median treatment duration was 4 months (range, 1-28) in this group. The most common adverse event was diarrhea: 8 (38.1%) patients. The ORR was 66.6% (20.0% CR and 46.6% PR) in the final response assessment during the treatment.
Conclusion
Ibrutinib is a good treatment option for CLL and other B-cell lymphomas, with an acceptable side effect profile, and high and promising CR/PR response rates. Ibrutinib treatment at an early stage decreases the burden of cytotoxic therapy in fragile patients, thereby, increasing their quality of life.
Keywords: Ibrutinib, Bruton’s tyrosine kinase, B-cell lymphoma, Chronic lymphocytic leukemia
Table 1 . Demographic and clinical features of the patients with CLL..
Demographic and baseline clinical features | N=11 (%) |
---|---|
Gender, female/male (%) | 4/7 (36.4/63.4) |
Age, median (range) | 65 (51–80) |
ECOG performance score≥3 | 1 (9.1) |
Bulky lesion, N (%) | 2 (18.2) |
Rai stage≥3, N (%) | 7 (63.6) |
Del17p, N (%) | 4 (36.4) |
N of previous treatments | |
0–1 | 5 (45.5) |
2–3 | 4 (36.4) |
>3 | 2 (18.1) |
Previous treatment regimens | |
R-FC | 7 (63.6) |
R-CVP | 4 (36.4) |
R-bendamustin | 3 (27.3) |
Chlorambucil | 2 (18.2) |
Other | 4 (36.4) |
Treatment duration with ibrutinib (mo, median) | 4 (2–18) |
Side effects of grade≥3 during treatment with ibrutinib | 4 (36.4) |
Treatment-emergent lymphocytosis, N (%) | 0 (0.0) |
Hb≤11 (g/dL), N (%) | 6 (54.5) |
Platelet≤100×109/L, N (%) | 7 (63.6) |
WBC (103/mL), mean (range) | 47,236 (1,300–182,900) |
Absolute lymphocyte count (103/mL), mean (range) | 38,200 (300–166,200) |
Table 2 . Incidence of adverse events (AEs) in patients with CLL and NHL..
CLL | NHL | |||
---|---|---|---|---|
Hematologic AEs | Grade 3–4, N (%) | Any grade, N (%) | Grade 3–4, N (%) | Any grade, N (%) |
Anemia | 0 (0) | 1 (9.1) | 0 (0) | 0 (0) |
Thrombocytopenia | 0 (0) | 2 (18.1) | 1 (4.8) | 2 (9.5) |
Neutropenia | 0 (0) | 2 (18.1) | 1 (4.8) | 1 (4.8) |
Lymphocytosis | 0 (0) | 2 (18.1) | 0 (0) | 2 (9.5) |
Non-hematologic AEs | ||||
Diarrhea | 1 (9.1) | 3 (27.3) | 2 (9.5) | 8 (38.1) |
Pneumonia | 3 (27.3) | 3 (27.3) | 1 (4.8) | 5 (23.8) |
Hemorrhage | 0 (0) | 1 (9.1) | 0 (0) | 0 (0) |
Atrial fibrillation | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Table 3 . Demographic and clinical features of patients with NHL..
Demographic and baseline clinical features | N=21 (%) |
---|---|
Gender, female/male, N (%) | 9/12 (42.9/57.1) |
Age, median (range) | 69 (53–84) |
Types of NHL | |
Mantle cell lymphoma, N (%) | 7 (33.4) |
Diffuse large B-cell lymphoma, N (%) | 5 (23.8) |
Marginal zone lymphoma, N (%) | 4 (19.0) |
Waldenström macroglobulinemia, N (%) | 3 (14.3) |
Follicular lymphoma, N (%) | 2 (9.5) |
High prognosis score, N (%) | 14 (66.7) |
ECOG performance score≥3, N (%) | 8 (38.1) |
Bulky lesion, N (%) | 4 (19.0) |
Ann Arbor stage≥3, N (%) | 20 (95.2) |
Presence of B symptoms, N (%) | 10 (47.6) |
N of previous treatments | |
1 | 9 (42.9) |
2 | 9 (42.9) |
3 | 3 (14.2) |
Previous treatment regimens | |
R-CHOP/CHOP | 20 (95.2) |
R-bortezomib/bortezomib | 5 (23.8) |
R-CVP/CVP | 3 (14.2) |
Diğer | 7 (33.4) |
Treatment duration with ibrutinib, median (range) | 4 (1–28) |
Patient requiring dose reduction, N (%) | 3 (14.3) |
Side effect of grade≥3 during treatment with ibrutinib | 5 (23.8) |
Treatment-emergent lymphocytosis, N (%) | 2 (9.5) |
Hb (g/dL), median (range) | 11.8 (7.6–14.6) |
Platelet (103/mL), median (range) | 165,000 (16,000–492,000) |
WBC (103/mL), median (range) | 8,400 (3,200–157,800) |
LDH U/L, median (range) | 257 (105–437) |
Creatinine clearance (mL/min/1.73 m2), median (range) | 64 (26–120) |
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