Real-world results of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia: Data from 95 consecutive patients treated in a compassionate use program. A study from the swedish chronic lymphocytic leukemia group

Haematologica

Volumn 101, Issue 12, 2016, Pages 1573-1580

  Winqvist, Maria ^a,b   Asklid, Anna ^a,b   Andersson, P O ^c   Karlsson, Karin ^d   Karlsson, Claes ^a,b   Lauri, Birgitta ^e   Lundin, Jeanette ^a,b   Mattsson, Mattias ^f   Norin, Stefan ^a   Sandstedt, Anna ^g   Hansson, Lotta ^a,b   Österborg, Anders ^a,b  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

^c Section of Hematology   (Sweden)

^d LUND UNIVERSITY HOSPITAL   (Sweden)

^e SUNDERBY HOSPITAL   (Sweden)

^f UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^g LINKÖPING UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; BENDAMUSTINE; CHLORAMBUCIL; GRANULOCYTE COLONY STIMULATING FACTOR; IBRUTINIB; IDELALISIB; OFATUMUMAB; RITUXIMAB; ANTINEOPLASTIC AGENT; PROTEIN KINASE INHIBITOR; PYRAZOLE DERIVATIVE; PYRIMIDINE DERIVATIVE;

AGED; ALLOGENEIC STEM CELL TRANSPLANTATION; ARTICLE; BONE MARROW BIOPSY; CHRONIC LYMPHATIC LEUKEMIA; COMPUTER ASSISTED TOMOGRAPHY; FEMALE; FOLLOW UP; GENE MUTATION; HEMATOMA; HUMAN; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; PROGRESSION FREE SURVIVAL; THROMBOCYTOPENIA; VERY ELDERLY; CANCER STAGING; CHROMOSOME ABERRATION; COMPASSIONATE USE; DISEASE COURSE; DRUG RESISTANCE; GENETICS; KAPLAN MEIER METHOD; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MIDDLE AGED; MORTALITY; PATHOLOGY; PROPORTIONAL HAZARDS MODEL; RECURRENT DISEASE; RETREATMENT; RETROSPECTIVE STUDY; SWEDEN; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CHROMOSOME ABERRATIONS; COMPASSIONATE USE TRIALS; DISEASE PROGRESSION; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; NEOPLASM STAGING; PROPORTIONAL HAZARDS MODELS; PROTEIN KINASE INHIBITORS; PYRAZOLES; PYRIMIDINES; RECURRENCE; RETREATMENT; RETROSPECTIVE STUDIES; SWEDEN; TREATMENT OUTCOME;

EID: 85002378033     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2016.144576     Document Type: Article

References (26)

1. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376 (9747):1164-1174.
2. Zenz T, Eichhorst B, Busch R, et al. TP53 mutation and survival in chronic lymphocytic leukemia. J Clin Oncol. 2010;28(29): 4473-4479.
3. Eketorp Sylvan S, Hansson L, Karlsson C, et al. Outcomes of patients with fludarabinerefractory chronic lymphocytic leukemia: a population-based study from a well-defined geographic region. Leuk Lymphoma. 2014;55(8):1774-1780.
4. Tam CS, O'Brien S, Lerner S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leuk Lymphoma. 2007;48 (10):1931-1939.
5. Pan Z, Scheerens H, Li SJ, et al. Discovery of selective irreversible inhibitors for Bruton's tyrosine kinase. ChemMedChem. 2007;2 (1):58-61.
6. Byrd JC, Harrington B, O'Brien S, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):323-332.
7. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111 (12):5446-5456.
8. Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42.
9. Byrd JC, Furman RR, Coutre SE, et al. Threeyear follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015;125(16):2497-2506.
10. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213-223.
11. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015;373(25):2425-2437.
12. Reynolds C, Di Bella N, Lyons RM, et al. A Phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in B-cell chronic lymphocytic leukemia. Invest New Drugs. 2012;30(3):1232-1240.
13. Terasawa T, Trikalinos NA, Djulbegovic B, Trikalinos TA. Comparative efficacy of firstline therapies for advanced-stage chronic lymphocytic leukemia: a multiple-treatment meta-analysis. Cancer Treat Rev. 2013;39(4): 340-349.
14. Abrahamsson A, Albertsson-Lindblad A, Brown PN, et al. Real world data on primary treatment for mantle cell lymphoma: a Nordic Lymphoma Group observational study. Blood. 2014;124(8):1288-1295.
15. Ellin F, Landstrom J, Jerkeman M, Relander T. Real-world data on prognostic factors and treatment in peripheral T-cell lymphomas: a study from the Swedish Lymphoma Registry. Blood. 2014;124(10):1570-1577.
16. Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059-3068.
17. Goede V, Bahlo J, Chataline V, et al. Evaluation of geriatric assessment in patients with chronic lymphocytic leukemia: Results of the CLL9 trial of the German CLL study group. Leuk Lymphoma. 2015:1-8.
18. Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995;43(2):130-137.
19. Fiegl M, Falkner A, Hopfinger G, et al. Routine clinical use of alemtuzumab in patients with heavily pretreated B-cell chronic lymphocytic leukemia: a nationwide retrospective study in Austria. Cancer. 2006;107(10):2408-2416.
20. Moreno C, Montillo M, Panayiotidis P, et al. Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a phase IV, noninterventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia. Haematologica. 2015;100(4):511-516.
21. Farooqui MZ, Valdez J, Martyr S, et al. Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: a phase 2, single-arm trial. Lancet Oncol. 2015;16(2): 169-176.
22. O'Brien S, Jones JA, Coutre S, et al. Efficacy and Safety of Ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia with 17p Deletion: Results from the Phase II RESONATE (TM)-17 Trial. 57th ASH Annual Meeting and Exposition. Orlando, FL, USA. Blood 2014;124(21).
23. Stilgenbauer S, Jones JA, Coutre S, et al. Outcome of Ibrutinib Treatment by Baseline Genetic Features in Patients with Relapsed or Refractory CLL/SLL with del17p in the Resonate-17 Study. 57th ASH Annual Meeting and Exposition. Orlando, FL, USA. Blood 2015:Abstract 833.
24. Farooqui M, Valdez J, Soto S, et al. Single Agent Ibrutinib in CLL/SLL Patients with and without Deletion 17p. 57th ASH Annual Meeting and Exposition. Orlando, FL, USA. Blood 2015:Abstract 2937.
25. Chanan-Khan A, Cramer P, Demirkan F, et al. Ibrutinib combined with bendamustine and rituximab (BR) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): First results from a randomized, double-blind, placebocontrolled, phase III study. ASCO Annual Meeting, Chicago, Illinois, USA. 2015: Abstract LBA7005.
26. Roberts AW, Davids MS, Pagel JM, et al. Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):311-322.