Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study

The Lancet - Tập 387 Số 10020 - Trang 770-778 - 2016
Martin Dreyling1, Wojciech Jurczak2, Mats Jerkeman3, Rodrigo Santucci Silva4, Chiara Rusconi5, Marek Trněný6, Fritz Offner7, Dolores Caballero8, Cristina João9,10, Mathias Witzens‐Harig11, Georg Heß12, Isabelle Bence‐Bruckler13, Seok‐Goo Cho14, John Bothos15, Jeffrey L. Goldberg15, Christopher Enny15, Shana Traina15, Sriram Balasubramanian16, Nibedita Bandyopadhyay15, Steven Sun15, Jessica Vermeulen17, Aleksandra Rizo15, Simon Rule18
1Department of Medicine III, Klinikum der Universität München, Campus Grosshadern, Munich, Germany
2Department of Hematology, Jagiellonian University, Krakow, Poland
3Skånes Universitetssjukhus, Lund, Lund, Sweden
4Instituto De Ensino E Pesquisa São Lucas, São Paulo, Brazil
5Hematology Division, Hematology and Oncology Department, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy
6Vseobecna fakultni nemocnice, Interni Klinika—Klinika Hematologie, Urologicka klinika, Prague, Czech Republic
7UZ Gent—Departement Oncologie, Gent, Belgium
8Instituto Biosanitario de Salamanca, Hospital Clinico Universitario Salamanca, Salamanca, Spain
9Champalimaud Centre for the Unknown, Hematology Department, Lisbon, Portugal
10Instituto Português de Oncologia, Lisbon, Portugal
11Klinikum der Ruprechts-Karls-Universität Heidelberg—Med. Klinik u. Poliklinik V, Heidelberg, Germany
12University Medical School of the Johannes Gutenberg-University, Department of Hematology, Oncology and Pneumology, Mainz, Germany
13The Ottawa Hospital—General Campus, Ottawa-Hospital General Campus, Ottawa, Canada
14Seoul St Mary's Hospital, Seocho-gu, Seoul, South Korea
15Janssen Research & Development, LLC, Raritan, NJ, USA
16Janssen Research & Development, LLC, Spring House, PA, USA
17Janssen Research & Development LLC, Leiden, the Netherlands
18Derriford Hospital, Plymouth, Devon, UK

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Tài liệu tham khảo

Cortelazzo, 2012, Mantle cell lymphoma, Crit Rev Oncol Hematol, 82, 78, 10.1016/j.critrevonc.2011.05.001

Herrmann, 2009, Improvement of overall survival in advanced stage mantle cell lymphoma, J Clin Oncol, 27, 511, 10.1200/JCO.2008.16.8435

Dreyling, 2014, Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 25, iii83, 10.1093/annonc/mdu264

Ferrero, 2013, The current therapeutic scenario for relapsed mantle cell lymphoma, Curr Opin Oncol, 25, 452, 10.1097/CCO.0b013e328363df0b

McKay, 2012, Guidelines for the investigation and management of mantle cell lymphoma, Br J Haematol, 159, 405, 10.1111/bjh.12046

Khan, 2012, Colonel Bruton's kinase defined the molecular basis of X-linked agammaglobulinemia, the first primary immunodeficiency, J Immunol, 188, 2933, 10.4049/jimmunol.1200490

Buggy, 2012, Bruton tyrosine kinase (BTK) and its role in B-cell malignancy, Int Rev Immunol, 31, 119, 10.3109/08830185.2012.664797

Cinar, 2013, Bruton tyrosine kinase is commonly overexpressed in mantle cell lymphoma and its attenuation by Ibrutinib induces apoptosis, Leuk Res, 37, 1271, 10.1016/j.leukres.2013.07.028

de Rooij, 2012, The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia, Blood, 119, 2590, 10.1182/blood-2011-11-390989

Herman, 2011, Bruton tyrosine kinase represents a promising therapeutic target for treatment of chronic lymphocytic leukemia and is effectively targeted by PCI-32765, Blood, 117, 6287, 10.1182/blood-2011-01-328484

Honigberg, 2010, The Bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy, Proc Natl Acad Sci USA, 107, 13075, 10.1073/pnas.1004594107

Ponader, 2012, The Bruton tyrosine kinase inhibitor PCI-32765 thwarts chronic lymphocytic leukemia cell survival and tissue homing in vitro and in vivo, Blood, 119, 1182, 10.1182/blood-2011-10-386417

Wang, 2013, Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma, N Engl J Med, 369, 507, 10.1056/NEJMoa1306220

Wang, 2015, Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results, Blood, 126, 739, 10.1182/blood-2015-03-635326

Wang, 2014, Efficacy and safety of single-agent ibrutinib in patients with mantle cell lymphoma who progressed after bortezomib therapy, Blood, 124, 4471, 10.1182/blood.V124.21.4471.4471

Rudelius, 2006, Constitutive activation of Akt contributes to the pathogenesis and survival of mantle cell lymphoma, Blood, 108, 1668, 10.1182/blood-2006-04-015586

Witzig, 2005, Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma, J Clin Oncol, 23, 5347, 10.1200/JCO.2005.13.466

Ansell, 2008, Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group, Cancer, 113, 508, 10.1002/cncr.23580

Hess, 2009, 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, 27, 3822, 10.1200/JCO.2008.20.7977

Cheson, 2007, Revised response criteria for malignant lymphoma, J Clin Oncol, 25, 579, 10.1200/JCO.2006.09.2403

Oken, 1982, Toxicity and response criteria of the Eastern Cooperative Oncology Group, Am J Clin Oncol, 5, 649, 10.1097/00000421-198212000-00014

Hoster, 2008, A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma, Blood, 111, 558, 10.1182/blood-2007-06-095331

Hlubocky, 2013, The development and validation of a measure of health-related quality of life for non-Hodgkin's lymphoma: the Functional Assessment of Cancer Therapy—Lymphoma (FACT-Lym), Lymphoma, 2013

Carter, 2008, Validation of the Functional Assessment of Therapy—Lymphoma (FACT-LYM) in patients with relapsed/refractory mantle cell lymphoma, Blood, 112, 828, 10.1182/blood.V112.11.2376.2376

Cella, 2005, Development of a measure of health-related quality of life for non-Hodgkin's lymphoma clinical research: the Functional Assessment of Cancer Therapy—Lymphoma (FACT-Lym), Blood, 106, 750, 10.1182/blood.V106.11.750.750

Fisher, 2006, Multicenter phase 2 study of bortezomib in patients with relapsed and refractory mantle cell lymphoma, J Clin Oncol, 24, 4867, 10.1200/JCO.2006.07.9665

Goy, 2013, Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study, J Clin Oncol, 31, 3688, 10.1200/JCO.2013.49.2835

Dreyling, 2013, A phase III study of ibrutinib in combination with bendamustine and rituximab (BR) in elderly patients with newly diagnosed mantle cell lymphoma (MCL), Hematol Oncol, 31, 137