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The introduction of Bruton's tyrosine kinase (BTK) inhibitors transformed the management of patients with mantle cell lymphoma (MCL). Ibrutinib, the first-in-class BTK inhibitor is now approved in more than 80 countries and there are over 20 new BTK inhibitors in development. In addition, novel agents show potential clinical activity (alone and in combination) and are in the approval phase and/or being studied in ongoing clinical trials. How does the practicing clinician decide on the optimal therapeutic strategy for this highly heterogenous disease? In July 2020 a group of experts from Italy, convened a meeting to address and provide clarification on a series of outstanding issues in the treatment of MCL with the view of providing clinical guidance on its management. This expert opinion statement represents the panel's collective analysis, evaluation, and recommendations and is made up of a series of questions and answers (in the form of a review of the pertinent literature) designed to replicate those posed by practicing clinicians in Italy but which are applicable to clinical settings worldwide.

Titel:	Use of BTK inhibitors with focus on ibrutinib in mantle cell lymphoma: An expert panel opinion statement.
Autor/in / Beteiligte Person:	Zinzani, PL ; Martelli, M ; Ferrero, S ; Gentile, M ; Laurenti, L ; Romana Mauro, F ; Sportoletti, P ; Tedeschi, A ; Varettoni, M ; Visco, C
Link:	Full Text Finder (Volltext)
Zeitschrift:	Hematological oncology, Jg. 40 (2022-10-01), Heft 4, S. 518-527
Veröffentlichung:	Oxford, England : Wiley-Blackwell, c1983-, 2022
Medientyp:	academicJournal
ISSN:	1099-1069 (electronic)
DOI:	10.1002/hon.2983
Schlagwort:	Adenine analogs & derivatives Adult Agammaglobulinaemia Tyrosine Kinase antagonists & inhibitors Humans Piperidines Antineoplastic Agents therapeutic use Lymphoma, Mantle-Cell drug therapy Lymphoma, Mantle-Cell pathology Protein Kinase Inhibitors pharmacology Protein Kinase Inhibitors therapeutic use
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Review Language: English [Hematol Oncol] 2022 Oct; Vol. 40 (4), pp. 518-527. <i>Date of Electronic Publication: </i>2022 Mar 14. MeSH Terms: Antineoplastic Agents* / therapeutic use ; Lymphoma, Mantle-Cell* / drug therapy ; Lymphoma, Mantle-Cell* / pathology ; Protein Kinase Inhibitors* / pharmacology ; Protein Kinase Inhibitors* / therapeutic use ; Adenine / analogs & derivatives ; Adult ; Agammaglobulinaemia Tyrosine Kinase / antagonists & inhibitors ; Humans ; Piperidines References: Wang ML, Rule S, Martin P, et al. BTK with ibrutinib in relapsed or refractory mantle-Cell lymphoma. N Engl J Med. 2013;369:507-516. ; Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770-778. ; Rule S, Dreyling M, Goy A, et al. Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open-label studies. Br J Haematol. 2017;179:430-438. ; Visco C, Di Rocco A, Evangelista A, et al. Outcomes in first relapsed-refractory younger patients with mantle cell lymphoma: results from the MANTLE-FIRST study. Leukemia. 2021;35(3):787-795. ; Wen T, Wang J, Shi Y, Qian H, Liu P. Inhibitors targeting Bruton’s tyrosine kinase in cancers: drug development advances. Leukemia. 2021;35(2):312-332. ; Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391:659-667. ; Tam CS, Wang M, Simpson D, et al. Updated safety and efficacy data in the phase 1 trial of patients with mantle cell lymphoma (MCL) treated with Bruton tyrosine kinase (BTK) inhibitor zanubrutinib (BGB-3111). Hematol Oncol. 2019;37:245-247. ; Bond DA, Maddocks KJ. 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Br J Haematol. 2019;185(5):940-944. ; Rule S, Cook G, Russell NH, et al. Allogeneic stem cell transplantation as part of front line therapy for mantle cell lymphoma. Br J Haematol. 2019;184(6):999-1005. ; Fenske TS, Zhang MJ, Carreras J, et al. Autologous or reduced-intensity conditioning allogeneic hematopoietic cell transplantation for chemotherapy-sensitive mantle-cell lymphoma: analysis of transplantation timing and modality. J Clin Oncol. 2014;32(4):273-281. ; McKay P, Leach M, Jackson B, Robinson S, Rule S. Guideline for the management of mantle cell lymphoma. Br J Haematol. 2018;182:46-62. ; Arcari A, Morello L, Vallisa D, et al. Allogeneic stem cell transplantation in patients with mantle cell lymphoma: results from the MANTLE-FIRST study on behalf of Fondazione Italiana Linfomi. Leuk Lymphoma. 2021;62(14):3474-3483. ; Dreger P, Michallet M, Bosman P, et al. Ibrutinib for bridging to allogeneic hematopoietic cell transplantation in patients with chronic lymphocytic leukemia or mantle cell lymphoma: a study by the EBMT Chronic Malignancies and Lymphoma Working Parties. Bone Marrow Transpl. 2019;54(1):44-52. ; Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus Venetoclax for the treatment of mantle-cell lymphoma. N Engl J Med. 2018;378:1211-1223. ; Wang ML, Blum KA, Martin P, et al. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015;126:739-745. ; Rule S, Dreyling MH, Goy A, et al. Long-term outcomes with ibrutinib versusthe prior regimen: a pooled analysis in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with up to 7.5 years of extended follow-up. Presented at: 61st American Society of Hematology Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 1538. ; Rodrigues JM, Hassan M, Freiburghaus C, et al. p53 is associated with high-risk and pinpoints TP53 missense mutations in mantle cell lymphoma. Br J Haematol. 2020;191(5):796-805. ; Eskelund CW, Kolstad A, Jerkeman M, et al. 15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016;175:410-418. ; Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130(17):1903-1910. ; Cortelazzo S, Mian M, Evangelista A, et al. Upfront intensive chemo-immunotherapy with autograft in 199 adult mantle cell lymphoma patients: prolonged survival and cure potentiality at long term. Bone Marrow Transpl. 2021;56(10):2606-2609. ; Jeong S, Park YJ, Yun W, et al. Genetic heterogeneity and prognostic impact of recurrent ANK2 and TP53 mutations in mantle cell lymphoma: a multi-centre cohort study. Sci Rep. 2020;10:13359. ; Hill HA, Qi X, Jain P, et al. Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis. Blood Adv. 2020;4(13):2927-2938. ; Ferrero S, Rossi D, Rinaldi A, et al. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020;105:1604-1612. ; Burroni B, Moreau A, Baldacini M, et al. P16, c-Myc, SOX11, P53, ki67 and CD71protein expression in aggressive morphological variants of mantle cell lymphomas compared to classical morphological mantle cell lymphomas in multiple clinical trials. Blood. 2019;134:2820. ; Jerkeman M, Eskelund CW, Hutchings M, et al. Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial. Lancet Haematol 2018;5:e109-e116. ; Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893-2962. ; Shatzel JJ, Olson SR, Tao DL, McCarty OJT, Danilov AV, DeLoughery TG. Ibrutinib-associated bleeding: pathogenesis, management and risk reduction strategies. J Thromb Haemostasisasis. 2017;15:835-847. ; Boriani G, Corradini P, Cuneo A, et al. Practical management of ibrutinib in the real life: focus on atrial fibrillation and bleeding. Hematol Oncol. 2018;36(4):624-632. ; Stühlinger MC, Weltermann A, Staber P, et al. Recommendations for ibrutinib treatment in patients with atrial fibrillation and/or elevated cardiovascular risk. Wien Klin Wochenschr. 2020;132:97-109. ; Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. ; Wang M, Barrientos JC, Furman RR, et al. VLS-101, a ROR1-targeting antibody-drug conjugate, demonstrates a predictable safety profile and clinical efficacy in patients with heavily pretreated mantle cell lymphoma and diffuse large B-cell lymphoma. Blood. 2020;136:13-14. ; Le Gouill S, Morschhauser F, Chiron D, et al. Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. Blood. 2021;137(7):877-887. Grant Information: None Contributed Indexing: Keywords: BTK inhibitors; ibrutinib; mantle cell lymphoma; real-world; recommendations Substance Nomenclature: 0 (Antineoplastic Agents) ; 0 (Piperidines) ; 0 (Protein Kinase Inhibitors) ; 1X70OSD4VX (ibrutinib) ; EC 2.7.10.2 (Agammaglobulinaemia Tyrosine Kinase) ; JAC85A2161 (Adenine) Entry Date(s): Date Created: 20220305 Date Completed: 20221007 Latest Revision: 20221013 Update Code: 20240513

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Use of BTK inhibitors with focus on ibrutinib in mantle cell lymphoma: An expert panel opinion statement.