Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study
Abstract The multicenter observational BiRD study investigated the real-world effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM) in Belgium. This interim analysis reports results for patients...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAABRON PRESS
2022-10-01
|
| Series: | Clinical Hematology International |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s44228-022-00020-8 |
| _version_ | 1797226810614743040 |
|---|---|
| author | Ann Janssens Zwi N. Berneman Fritz Offner Sylvia Snauwaert Philippe Mineur Gaetan Vanstraelen Stef Meers Isabelle Spoormans Dominique Bron Isabelle Vande Broek Charlotte Van Bogaert Birgit De Beleyr Ann Smet Lasse Nielsen Robert Wapenaar Marc André |
| author_facet | Ann Janssens Zwi N. Berneman Fritz Offner Sylvia Snauwaert Philippe Mineur Gaetan Vanstraelen Stef Meers Isabelle Spoormans Dominique Bron Isabelle Vande Broek Charlotte Van Bogaert Birgit De Beleyr Ann Smet Lasse Nielsen Robert Wapenaar Marc André |
| author_sort | Ann Janssens |
| collection | DOAJ |
| description | Abstract The multicenter observational BiRD study investigated the real-world effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM) in Belgium. This interim analysis reports results for patients with CLL, with a median follow-up of 34 months. Overall, patients had predominantly relapsed/refractory disease (73%) and were elderly (median age 72 years) with high-risk features such as del17p and/or TP53 mutations (59%). Patients were included either prospectively or retrospectively, and the total patient population effectiveness results were adjusted with left truncation. In the effectiveness population (N = 221: prospective, n = 71; retrospective, n = 150), the overall response rate was 90.0%. Median progression-free survival was 38.3 months (prospective, not estimable; retrospective, 51.5 months) and median overall survival was not yet estimable in the total, prospective and retrospective groups. Treatment-emergent adverse events (TEAEs) for the prospective and retrospective groups are reported separately. Any-grade TEAEs of interest in the prospective/retrospective groups included infections (67.1%/60.1%), diarrhea (20.5%/10.5%), hypertension (16.4%/9.8%) and atrial fibrillation (12.3%/7.2%). Major bleeding was reported in 5.5%/3.3% of prospective/retrospective patients, with little difference observed between those receiving versus not receiving antithrombotic treatment. Discontinuations due to toxicity were reported in 10.5% of patients. Results from this interim analysis show treatment with ibrutinib to be effective and tolerable, with no new safety signals observed. Future analyses will report on longer-term follow-up. |
| first_indexed | 2024-04-24T14:30:50Z |
| format | Article |
| id | doaj.art-246e8f0b6ff948258a81b9155851b6fa |
| institution | Directory Open Access Journal |
| issn | 2590-0048 |
| language | English |
| last_indexed | 2024-04-24T14:30:50Z |
| publishDate | 2022-10-01 |
| publisher | SAABRON PRESS |
| record_format | Article |
| series | Clinical Hematology International |
| spelling | doaj.art-246e8f0b6ff948258a81b9155851b6fa2024-04-03T02:44:34ZengSAABRON PRESSClinical Hematology International2590-00482022-10-014413314310.1007/s44228-022-00020-8Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) StudyAnn Janssens0Zwi N. Berneman1Fritz Offner2Sylvia Snauwaert3Philippe Mineur4Gaetan Vanstraelen5Stef Meers6Isabelle Spoormans7Dominique Bron8Isabelle Vande Broek9Charlotte Van Bogaert10Birgit De Beleyr11Ann Smet12Lasse Nielsen13Robert Wapenaar14Marc André15Department of Hematology, Universitair Ziekenhuis LeuvenDepartment of Hematology, Universitair Ziekenhuis AntwerpenDepartment of Internal Medicine and Pediatrics, Ghent University HospitalDepartment of Hematology, AZ Sint-Jan BruggeDepartment of Hematology, Grand Hôpital De Charleroi - Notre DameDepartment of Hematology, CHR VerviersDepartment of Hematology, AZ KLINADepartment of Hematology, AZ DamiaanDepartment of Hematology, Institut Jules Bordet (ULB)Department of Oncology, AZ NikolaasJanssen-Cilag NVJanssen-Cilag NVJanssen-Cilag NVJanssen-Cilag NVJanssen-Cilag BVDepartment of Hematology, Université Catholique de Louvain, CHU UCLAbstract The multicenter observational BiRD study investigated the real-world effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM) in Belgium. This interim analysis reports results for patients with CLL, with a median follow-up of 34 months. Overall, patients had predominantly relapsed/refractory disease (73%) and were elderly (median age 72 years) with high-risk features such as del17p and/or TP53 mutations (59%). Patients were included either prospectively or retrospectively, and the total patient population effectiveness results were adjusted with left truncation. In the effectiveness population (N = 221: prospective, n = 71; retrospective, n = 150), the overall response rate was 90.0%. Median progression-free survival was 38.3 months (prospective, not estimable; retrospective, 51.5 months) and median overall survival was not yet estimable in the total, prospective and retrospective groups. Treatment-emergent adverse events (TEAEs) for the prospective and retrospective groups are reported separately. Any-grade TEAEs of interest in the prospective/retrospective groups included infections (67.1%/60.1%), diarrhea (20.5%/10.5%), hypertension (16.4%/9.8%) and atrial fibrillation (12.3%/7.2%). Major bleeding was reported in 5.5%/3.3% of prospective/retrospective patients, with little difference observed between those receiving versus not receiving antithrombotic treatment. Discontinuations due to toxicity were reported in 10.5% of patients. Results from this interim analysis show treatment with ibrutinib to be effective and tolerable, with no new safety signals observed. Future analyses will report on longer-term follow-up.https://doi.org/10.1007/s44228-022-00020-8IbrutinibChronic lymphocytic leukemiaBelgiumReal-world evidenceEffectivenessSafety |
| spellingShingle | Ann Janssens Zwi N. Berneman Fritz Offner Sylvia Snauwaert Philippe Mineur Gaetan Vanstraelen Stef Meers Isabelle Spoormans Dominique Bron Isabelle Vande Broek Charlotte Van Bogaert Birgit De Beleyr Ann Smet Lasse Nielsen Robert Wapenaar Marc André Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study Clinical Hematology International Ibrutinib Chronic lymphocytic leukemia Belgium Real-world evidence Effectiveness Safety |
| title | Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study |
| title_full | Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study |
| title_fullStr | Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study |
| title_full_unstemmed | Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study |
| title_short | Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study |
| title_sort | effectiveness and safety of ibrutinib for chronic lymphocytic leukemia in routine clinical practice 3 year follow up of the belgian ibrutinib real world data bird study |
| topic | Ibrutinib Chronic lymphocytic leukemia Belgium Real-world evidence Effectiveness Safety |
| url | https://doi.org/10.1007/s44228-022-00020-8 |
| work_keys_str_mv | AT annjanssens effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT zwinberneman effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT fritzoffner effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT sylviasnauwaert effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT philippemineur effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT gaetanvanstraelen effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT stefmeers effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT isabellespoormans effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT dominiquebron effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT isabellevandebroek effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT charlottevanbogaert effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT birgitdebeleyr effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT annsmet effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT lassenielsen effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT robertwapenaar effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy AT marcandre effectivenessandsafetyofibrutinibforchroniclymphocyticleukemiainroutineclinicalpractice3yearfollowupofthebelgianibrutinibrealworlddatabirdstudy |