Real-world outcomes for 205 patients with chronic lymphocytic leukemia treated with ibrutinib

被引:42
作者
Aarup, Kathrine [1 ]
Rotbain, Emelie Curovic [1 ,2 ]
Enggaard, Lisbeth [3 ]
Pedersen, Robert Schou [4 ]
Bergmann, Olav Jonas [5 ]
Thomsen, Rasmus Heje [6 ]
Frederiksen, Mikael [7 ]
Frederiksen, Henrik [2 ]
Nielsen, Tine [2 ]
Christiansen, Ilse [8 ]
Andersen, Michael Asger [1 ]
Niemann, Carsten Utoft [1 ]
机构
[1] Copenhagen Univ Hosp, Rigshosp, Dept Hematol, L-4041,Blegdamsvej 9, DK-2100 Copenhagen, Denmark
[2] Odense Univ Hosp, Dept Hematol, Odense, Denmark
[3] Herlev & Gentofte Hosp, Dept Hematol, Herlev, Denmark
[4] Hosp Senheden Vest, Dept Hematol, Holstebro, Denmark
[5] Sygehus Lillebaelt, Dept Hematol, Vejle, Denmark
[6] Zealand Univ Hosp, Dept Hematol, Roskilde, Denmark
[7] Sygehus Snderjylland, Dept Hematol, Aabenraa, Denmark
[8] Aalborg Univ Hosp, Dept Hematol, Aalborg, Denmark
基金
新加坡国家研究基金会;
关键词
chronic lymphocytic leukemia; epidemiology; targeted therapy; SURVIVAL; BTK;
D O I
10.1111/ejh.13499
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Ibrutinib has now been approved for treatment of chronic lymphocytic leukemia (CLL) in both front-line setting and as later-line treatment. However, knowledge about the outcomes and adverse events (AE) among patients at a population-based level is still limited. Objectives To report outcomes and AEs in a population-based cohort treated with ibrutinib outside clinical trials. Methods We conducted a multicenter, retrospective cohort study including all patients with CLL treated with ibrutinib. Results In total, 205 patients were included of whom 39 (19%) were treatment-naive. The median follow-up was 21.4 months (interquartile range (IQR), 11.9,32.8), the estimated overall survival at 12 months was 88.8% (95% confidence interval (CI); 84.3%, 93.3%), and the estimated progression-free survival at 12 months was 86.3% (95% CI; 81.3%, 91.2%). During follow-up, 200 (97.6%) patients had at least one AE and 100 (48.8%) patients had at least one grade >= 3 AE. Eighty-six patients (42.0%) discontinued ibrutinib, hereof 47 (54.7%) due to AEs and 19 (22.1%) had progression of CLL or Richter transformation. Conclusions In our study, we find comparable, though slightly inferior, overall, and progression-free survival, and discontinuation due to toxicity was higher compared with clinical trials. Patient training and information may improve treatment adherence outside clinical trials.
引用
收藏
页码:646 / 654
页数:9
相关论文
共 26 条
[1]  
[Anonymous], 2019, COMMON TERMINOLOGY C
[2]   Extended follow-up and impact of high-risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL [J].
Brown, J. R. ;
Hillmen, P. ;
O'Brien, S. ;
Barrientos, J. C. ;
Reddy, N. M. ;
Coutre, S. E. ;
Tam, C. S. ;
Mulligan, S. P. ;
Jaeger, U. ;
Barr, P. M. ;
Furman, R. R. ;
Kipps, T. J. ;
Cymbalista, F. ;
Thornton, P. ;
Caligaris-Cappio, F. ;
Delgado, J. ;
Montillo, M. ;
DeVos, S. ;
Moreno, C. ;
Pagel, J. M. ;
Munir, T. ;
Burger, J. A. ;
Chung, D. ;
Lin, J. ;
Gau, L. ;
Chang, B. ;
Cole, G. ;
Hsu, E. ;
James, D. F. ;
Byrd, J. C. .
LEUKEMIA, 2018, 32 (01) :83-91
[3]   Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia [J].
Burger, J. A. ;
Tedeschi, A. ;
Barr, P. M. ;
Robak, T. ;
Owen, C. ;
Ghia, P. ;
Bairey, O. ;
Hillmen, P. ;
Bartlett, N. L. ;
Li, J. ;
Simpson, D. ;
Grosicki, S. ;
Devereux, S. ;
McCarthy, H. ;
Coutre, S. ;
Quach, H. ;
Gaidano, G. ;
Maslyak, Z. ;
Stevens, D. A. ;
Janssens, A. ;
Offner, F. ;
Mayer, J. ;
O'Dwyer, M. ;
Hellmann, A. ;
Schuh, A. ;
Siddiqi, T. ;
Polliack, A. ;
Tam, C. S. ;
Suri, D. ;
Cheng, M. ;
Clow, F. ;
Styles, L. ;
James, D. F. ;
Kipps, T. J. ;
Keating, Michael ;
Jen, Jie ;
Jindra, Pavel ;
Simkovic, Martin ;
Braester, Andrei ;
Ruchlemer, Rosa ;
Foa, Roberto ;
Semenzato, Gianpietro ;
Hawkins, Timothy ;
Atanasio, Carolina Moreno ;
Demirkan, Fatih ;
Kaynar, Leylagul ;
Pylypenko, Halyna ;
Fox, Christopher ;
Thirman, Michael ;
Campbell, Philip .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (25) :2425-2437
[4]   Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study [J].
Burger, Jan A. ;
Barr, Paul M. ;
Robak, Tadeusz ;
Owen, Carolyn ;
Ghia, Paolo ;
Tedeschi, Alessandra ;
Bairey, Osnat ;
Hillmen, Peter ;
Coutre, Steven E. ;
Devereux, Stephen ;
Grosicki, Sebastian ;
McCarthy, Helen ;
Simpson, David ;
Offner, Fritz ;
Moreno, Carol ;
Dai, Sandra ;
Lal, Indu ;
Dean, James P. ;
Kipps, Thomas J. .
LEUKEMIA, 2020, 34 (03) :787-798
[5]   Evolution of CLL treatment - from chemoimmunotherapy to targeted and individualized therapy [J].
Burger, Jan A. ;
O'Brien, Susan .
NATURE REVIEWS CLINICAL ONCOLOGY, 2018, 15 (08) :510-527
[6]   Bruton's Tyrosine Kinase (BTK) Inhibitors in Clinical Trials [J].
Burger, Jan A. .
CURRENT HEMATOLOGIC MALIGNANCY REPORTS, 2014, 9 (01) :44-49
[7]   Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia [J].
Byrd, J. C. ;
Brown, J. R. ;
O'Brien, S. ;
Barrientos, J. C. ;
Kay, N. E. ;
Reddy, N. M. ;
Coutre, S. ;
Tam, C. S. ;
Mulligan, S. P. ;
Jaeger, U. ;
Devereux, S. ;
Barr, P. M. ;
Furman, R. R. ;
Kipps, T. J. ;
Cymbalista, F. ;
Pocock, C. ;
Thornton, P. ;
Caligaris-Cappio, F. ;
Robak, T. ;
Delgado, J. ;
Schuster, S. J. ;
Montillo, M. ;
Schuh, A. ;
de Vos, S. ;
Gill, D. ;
Bloor, A. ;
Dearden, C. ;
Moreno, C. ;
Jones, J. J. ;
Chu, A. D. ;
Fardis, M. ;
McGreivy, J. ;
Clow, F. ;
James, D. F. ;
Hillmen, P. .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (03) :213-223
[8]   Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia [J].
Byrd, John C. ;
Furman, Richard R. ;
Coutre, Steven E. ;
Flinn, Ian W. ;
Burger, Jan A. ;
Blum, Kristie A. ;
Grant, Barbara ;
Sharman, Jeff P. ;
Coleman, Morton ;
Wierda, William G. ;
Jones, Jeffrey A. ;
Zhao, Weiqiang ;
Heerema, Nyla A. ;
Johnson, Amy J. ;
Sukbuntherng, Juthamas ;
Chang, Betty Y. ;
Clow, Fong ;
Hedrick, Eric ;
Buggy, Joseph J. ;
James, Danelle F. ;
O'Brien, Susan .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (01) :32-42
[9]  
Christiansen I, 2019, NATL RETNINGSLINJER
[10]   The Danish National Chronic Lymphocytic Leukemia Registry [J].
da Cunha-Bang, Caspar ;
Geisler, Christian Hartmann ;
Enggaard, Lisbeth ;
Poulsen, Christian Bjorn ;
Brown, Peter de Nully ;
Frederiksen, Henrik ;
Bergmann, Olav Jonas ;
Pulczynski, Elisa Jacobsen ;
Pedersen, Robert Schou ;
Nielsen, Linda Hojberg ;
Christiansen, Ilse ;
Niemann, Carsten Utoft .
CLINICAL EPIDEMIOLOGY, 2016, 8 :561-565