FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL

被引：7

作者：

Dartigeas C. ^{[1
]}

Slama B. ^{[2
]}

Doyle M. ^{[3
]}

Tapprich C. ^{[4
]}

Albrecht C. ^{[5
]}

Dupuis S. ^{[5
]}

Wapenaar R. ^{[6
]}

Schmidt-Hieber C. ^{[7
]}

Leblond V. ^{[8
]}

机构：

[1] Service Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Tours

[2] CH Henri Duffaut, Avignon

[3] Janssen Sciences Ireland, Dublin

[4] EMEA Medical Affairs, Janssen-Cilag, Neuss

[5] Janssen France, Issy-les-Moulineaux

[6] Janssen-Cilag B.V., Breda

[7] APHP, Hôpital Saint-Louis, Hemato-Oncologie, Université de Paris, Paris

[8] Hematology Department, Hopital Pitie-Salpêtrière, Paris

来源：

Clinical Hematology International | 2022年 / 4卷 / 3期

关键词：

Chronic lymphocytic leukemia; Effectiveness; Ibrutinib; Mantle cell lymphoma; Real-world evidence; Safety;

D O I：

10.1007/s44228-022-00015-5

中图分类号：

学科分类号：

摘要：

The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. First-line CLL/SLL patients had del17p and/or TP53 mutations. In this interim analysis, the median follow-up time for patients with CLL/SLL and MCL was 17.7 and 15.1 months, respectively. In the effectiveness populations for CLL/SLL (n = 200) and MCL (n = 59), the median progression-free survival was not estimable and 12.4 months, respectively; the 12-month overall survival rates were 88.5% and 65.8%, respectively. Treatment-emergent adverse events of interest for patients with CLL/SLL (n = 202) and MCL (n = 59) included: infections and infestations (53.5% and 32.2%), major bleeding (5.0% and 5.1%), and atrial fibrillation (5.9% and 8.5%); 135 (66.8%) and 20 (33.9%) patients were continuing treatment at the time of data cutoff. Future analyses will report on longer-term follow-up (Trial registration: ClinicalTrials.gov, NCT03425591. Registered 1 February 2018—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03425591). © 2022, The Author(s).

引用

页码：65 / 74

页数：9

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