Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma

New England Journal of Medicine

Volumn 369, Issue 6, 2013, Pages 507-516

  Wang, Michael L ^a   Rule, Simon ^c   Martin, Peter ^g   Goy, Andre ⁱ   Auer, Rebecca ^d   Kahl, Brad S ^j   Jurczak, Wojciech ^k   Advani, Ranjana H ⁿ   Romaguera, Jorge E ^a   Williams, Michael E ^p   Barrientos, Jacqueline C ^h   Chmielowska, Ewa ^l   Radford, John ^e   Stilgenbauer, Stephan ^q   Dreyling, Martin ^r   Jedrzejczak, Wieslaw Wiktor ^m   Johnson, Peter ^f   Spurgeon, Stephen E ^s   Li, Lei ^a   Zhang, Liang ^a   Newberry, Kate ^a   Ou, Zhishuo ^a   Cheng, Nancy ^b   Fang, Bingliang ^a   McGreivy, Jesse ^o   Clow, Fong ^o   Buggy, Joseph J ^o   Chang, Betty Y ^o   Beaupre, Darrin M ^o   Kunkel, Lori A ^o   Blum, Kristie A ^t   more..

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c DERRIFORD HOSPITAL   (United Kingdom)

^d BARTS HEALTH NHS TRUST   (United Kingdom)

^e UNIVERSITY OF MANCHESTER   (United Kingdom)

^f UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^g WEILL CORNELL MEDICAL COLLEGE   (United States)

^h DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

ⁱ HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^j UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^k JAGIELLONIAN UNIVERSITY   (Poland)

^l Regional Oncology Centre Bydgoszcz   (Poland)

^m MEDICAL UNIVERSITY OF WARSAW   (Poland)

ⁿ STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o PHARMACYCLICS INC   (United States)

^p UNIVERSITY OF VIRGINIA   (United States)

^q UNIVERSITY HOSPITAL ULM   (Germany)

^r LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^s OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^t OHIO STATE UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; BRUTON TYROSINE KINASE; CD19 ANTIGEN; CD3 ANTIGEN; CD5 ANTIGEN; IBRUTINIB; MACROPHAGE DERIVED CHEMOKINE; MACROPHAGE INFLAMMATORY PROTEIN 1ALPHA; MACROPHAGE INFLAMMATORY PROTEIN 1BETA; TUMOR NECROSIS FACTOR ALPHA;

ADENOCARCINOMA; ADULT; AGED; ANEMIA; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CANCER PROGNOSIS; CANCER SURVIVAL; CONSTIPATION; CONTROLLED STUDY; CYTOKINE RELEASE; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; HEART ARREST; HEMATOLOGIC DISEASE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN CELL; IMMUNOGLOBULIN A BLOOD LEVEL; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOGLOBULIN G BLOOD LEVEL; IMMUNOGLOBULIN M BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MANTLE CELL LYMPHOMA; METASTATIC ADENOCARCINOMA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; OPEN STUDY; OVERALL SURVIVAL; PERIPHERAL BLOOD MONONUCLEAR CELL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; RESPIRATORY FAILURE; RISK BENEFIT ANALYSIS; SEPSIS; SIDE EFFECT; SUBDURAL HEMATOMA; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTE COUNT; THROMBOCYTOPENIA; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

EID: 84881225049     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1306220     Document Type: Article

References (29)

1. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma: the Non-Hodgkin's Lymphoma Classification Project. Blood 1997;89:3909-18.
2. Romaguera JE, Fayad LE, Feng L, et al. Ten-year follow-up after intense chemoimmunotherapy with rituximab-hyperCVAD alternating with rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol 2010;150:200-8. [Erratum, Br J Haematol 2010;151:111.]
3. Wiestner A. Targeting B-cell receptor signaling for anticancer therapy: the Bruton's tyrosine kinase inhibitor ibrutinib induces impressive responses in B-cell malignancies. J Clin Oncol 2013;31:128-30.
4. Davis RE, Ngo VN, Lenz G, et al. Chronic active B-cell-receptor signalling in diffuse large B-cell lymphoma. Nature 2010;463:88-92.
5. Kenkre VP, Kahl BS. The future of B-cell lymphoma therapy: the B-cell receptor and its downstream pathways. Curr Hematol Malig Rep 2012;7:216-20.
6. Buggy JJ, Elias L. Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol 2012;31:119-32. [Erratum, Int Rev Immunol 2012;31:428.]
7. Rushworth SA, Bowles KM, Barrera LN, Murray MY, Zaitseva L, MacEwan DJ. BTK inhibitor ibrutinib is cytotoxic to myeloma and potently enhances bortezomib and lenalidomide activities through NF-κB. Cell Signal 2013;25:106-12.
8. Harrison C. Trial watch: BTK inhibitor shows positive results in B cell malignancies. Nat Rev Drug Discov 2012;11:96.
9. Alinari L, Christian B, Baiocchi RA. Novel targeted therapies for mantle cell lymphoma. Oncotarget 2012;3:203-11.
10. Hadzidimitriou A, Agathangelidis A, Darzentas N, et al. Is there a role for antigen selection in mantle cell lymphoma? Immunogenetic support from a series of 807 cases. Blood 2011;118:3088-95.
11. Rinaldi A, Kwee I, Taborelli M, et al. Genomic and expression profiling identifies the B-cell associated tyrosine kinase Syk as a possible therapeutic target in mantle cell lymphoma. Br J Haematol 2006;132:303-16. (Pubitemid 43381537)
12. Chang BY, Francesco M, Steggerda S, et al. Ibrutinib inhibits malignant cell adhesion and migration and reduces tumor burden in lymph node and bone marrow in a murine model of mantle cell dissemination and progression. Presented at the American Association for Cancer Research Annual Meeting 2013, Washington, DC, April 6-10, 2013. abstract.
13. Herman SE, Gordon AL, Hertlein E, et al. Bruton tyrosine kinase represents a promising therapeutic target for treatment of chronic lymphocytic leukemia and is effectively targeted by PCI-32765. Blood 2011;117:6287-96.
14. Advani RH, Buggy JJ, Sharman JP, et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol 2013;31:88-94.
15. Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 2013;369:32-42.
16. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86. (Pubitemid 350002966)
17. Cancer Therapy Evaluation Program CTCfAE, version 4.0. May 28, 2009 (http://ctep.cancer.gov/protocolDevelopment/electronic-applications/ctc. htm#ctc-30).
18. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. (Pubitemid 19099520)
19. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
20. de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood 2012;119:2590-4.
21. + cells into peripheral blood following treatment with the Bruton tyrosine kinase inhibitor, PCI-32765, in mantle cell lymphoma patients. Blood 2011;118:436. abstract.
22. Wang M, Zhang L, Han X, et al. A severe combined immunodeficient-hu in vivo mouse model of human primary mantle cell lymphoma. Clin Cancer Res 2008;14:2154-60. (Pubitemid 351551128)
23. Aspegren OP, Åstrand R, Lundgren MI, Romner B. Anticoagulation therapy a risk factor for the development of chronic subdural hematoma. Clin Neurol Neurosurg 2012 November 2 (Epub ahead of print).
24. Velasquez WS, McLaughlin P, Tucker S, et al. ESHAP - an effective chemotherapy regimen in refractory and relapsing lymphoma: a 4-year follow-up study. J Clin Oncol 1994;12:1169-76. (Pubitemid 24173930)
25. Rodriguez MA, Cabanillas FC, Velasquez W, et al. Results of a salvage treatment program for relapsing lymphoma: MINE consolidated with ESHAP. J Clin Oncol 1995;13:1734-41.
26. Wang M, Fayad L, Cabanillas F, et al. Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma. Cancer 2008;113:2734-41.
27. Vose J, Sneller V. Outpatient regimen rituximab plus ifosfamide, carboplatin and etoposide (R-ICE) for relapsed non-Hodgkin's lymphoma. Ann Oncol 2003;14:Suppl 1:i17-i20. [Erratum, Ann Oncol 2004;15:541.] (Pubitemid 36701719)
28. Hess G, Herbrecht R, Romaguera J, et al. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol 2009;27:3822-9.
29. Fisher RI, Bernstein SH, Kahl BS, et al. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol 2006;24:4867-74. (Pubitemid 46655613)