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

The Lancet

Volumn 387, Issue 10020, 2016, Pages 770-778

  Dreyling, Martin ^a   Jurczak, Wojciech ^b   Jerkeman, Mats ^c   Silva, Rodrigo Santucci ^d   Rusconi, Chiara ^e   Trneny, Marek ^f   Offner, Fritz ^g   Caballero, Dolores ^h   Joao, Cristina ^i,q   Witzens Harig, Mathias ^j   Hess, Georg ^k   Bence Bruckler, Isabelle ^l   Cho, Seok Goo ^m   Bothos, John ⁿ   Goldberg, Jenna D ⁿ   Enny, Christopher ⁿ   Traina, Shana ⁿ   Balasubramanian, Sriram ⁿ   Bandyopadhyay, Nibedita ⁿ   Sun, Steven ⁿ   Vermeulen, Jessica ^o   Rizo, Aleksandra ⁿ   Rule, Simon ^p   more..

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b JAGIELLONIAN UNIVERSITY   (Poland)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d Clinical Research Unit Instituto de Ensino e Pesquisa São Lucas   (Brazil)

^e OSPEDALE NIGUARDA CA GRANDA   (Italy)

^f CHARLES UNIVERSITY   (Czech Republic)

^g GHENT UNIVERSITY HOSPITAL   (Belgium)

^h HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

ⁱ CHAMPALIMAUD CENTRE FOR THE UNKNOWN   (Portugal)

^j UNIVERSITY OF HEIDELBERG   (Germany)

^k JOHANNES GUTENBERG UNIVERSITY   (Germany)

^l UNIVERSITY OF OTTAWA   (Canada)

^m The Catholic University of Korea   (South Korea)

ⁿ JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^o Janssen Research and Development   (Netherlands)

^p DERRIFORD HOSPITAL   (United Kingdom)

^q INSTITUTO PORTUGUÊS DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL   (Portugal)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BENDAMUSTINE; CYCLOPHOSPHAMIDE; IBRUTINIB; RITUXIMAB; TEMSIROLIMUS; ANTINEOPLASTIC AGENT; PYRAZOLE DERIVATIVE; PYRIMIDINE DERIVATIVE; RAPAMYCIN;

AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RECURRENCE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MANTLE CELL LYMPHOMA; MANTLE CELL LYMPHOMA INTERNATIONAL PROGNOSTIC INDEX; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; TREATMENT DURATION; TREATMENT REFUSAL; ANALOGS AND DERIVATIVES; CANCER STAGING; CLINICAL TRIAL; COMPARATIVE STUDY; KAPLAN MEIER METHOD; LYMPHOMA, MANTLE-CELL; MIDDLE AGED; PATHOLOGY; RECURRENT DISEASE; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPHOMA, MANTLE-CELL; MALE; MIDDLE AGED; NEOPLASM STAGING; PYRAZOLES; PYRIMIDINES; RECURRENCE; SIROLIMUS; TREATMENT OUTCOME;

EID: 84959074796     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)00667-4     Document Type: Article

References (29)

1. S Cortelazzo, M Ponzoni, AJ Ferreri, M Dreyling Mantle cell lymphoma Crit Rev Oncol Hematol 82 2012 78 101
2. A Herrmann, E Hoster, T Zwingers et al. Improvement of overall survival in advanced stage mantle cell lymphoma J Clin Oncol 27 2009 511 518
3. M Dreyling, C Geisler, O Hermine et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Ann Oncol 25 suppl 3 2014 iii83 iii92
4. S Ferrero, M Dreyling The current therapeutic scenario for relapsed mantle cell lymphoma Curr Opin Oncol 25 2013 452 462
5. P McKay, M Leach, R Jackson, G Cook, S Rule Guidelines for the investigation and management of mantle cell lymphoma Br J Haematol 159 2012 405 426
6. WN Khan Colonel Bruton's kinase defined the molecular basis of X-linked agammaglobulinemia, the first primary immunodeficiency J Immunol 188 2012 2933 2935
7. JJ Buggy, L Elias Bruton tyrosine kinase (BTK) and its role in B-cell malignancy Int Rev Immunol 31 2012 119 132
8. M Cinar, F Hamedani, Z Mo, B Cinar, HM Amin, S Alkan Bruton tyrosine kinase is commonly overexpressed in mantle cell lymphoma and its attenuation by Ibrutinib induces apoptosis Leuk Res 37 2013 1271 1277
9. MF de Rooij, A Kuil, CR Geest et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia Blood 119 2012 2590 2594
10. SE Herman, AL Gordon, E Hertlein et al. Bruton tyrosine kinase represents a promising therapeutic target for treatment of chronic lymphocytic leukemia and is effectively targeted by PCI-32765 Blood 117 2011 6287 6296
11. LA Honigberg, AM Smith, M Sirisawad et al. 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 2010 13075 13080
12. S Ponader, SS Chen, JJ Buggy et al. The Bruton tyrosine kinase inhibitor PCI-32765 thwarts chronic lymphocytic leukemia cell survival and tissue homing in vitro and in vivo Blood 119 2012 1182 1189
13. ML Wang, S Rule, P Martin et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma N Engl J Med 369 2013 507 516
14. ML Wang, KA Blum, P Martin et al. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results Blood 126 2015 739 745
15. M Wang, A Goy, P Martin et al. Efficacy and safety of single-agent ibrutinib in patients with mantle cell lymphoma who progressed after bortezomib therapy Blood 124 2014 4471
16. M Rudelius, S Pittaluga, S Nishizuka et al. Constitutive activation of Akt contributes to the pathogenesis and survival of mantle cell lymphoma Blood 108 2006 1668 1676
17. TE Witzig, SM Geyer, I Ghobrial et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma J Clin Oncol 23 2005 5347 5356
18. SM Ansell, DJ Inwards, KM Rowland Jr et al. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group Cancer 113 2008 508 514
19. G Hess, R Herbrecht, J Romaguera 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 27 2009 3822 3829
20. BD Cheson, B Pfistner, ME Juweid et al. Revised response criteria for malignant lymphoma J Clin Oncol 25 2007 579 586
21. MM Oken, RH Creech, DC Tormey et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group Am J Clin Oncol 5 1982 649 655
22. E Hoster, M Dreyling, W Klapper et al. A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma Blood 111 2008 558 565
23. FJ Hlubocky, K Webster, J Cashy, J Beaumont, D Cella 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 2013 10.1155/2013/147176
24. GC Carter, A Liepa, AH Zimmerman, F Morschhauser Validation of the Functional Assessment of Therapy - Lymphoma (FACT-LYM) in patients with relapsed/refractory mantle cell lymphoma Blood 112 2008 828 Abstract 2376.
25. D Cella, K Webster, J Cashy et al. 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 2005 750
26. EMA/CHMP/205/95/Rev.4. Oncology Working Party. Appendix 1: guideline on the evaluation of anticancer medicinal products in man http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2013/01/WC500137128.pdf December 2012 (accessed Nov 4, 2015)
27. RI Fisher, SH Bernstein, BS Kahl et al. Multicenter phase 2 study of bortezomib in patients with relapsed and refractory mantle cell lymphoma J Clin Oncol 24 2006 4867 4874
28. A Goy, R Sinha, ME Williams et al. 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 2013 3688 3695
29. M Dreyling, L Gordon, S Rule et al. 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 suppl 1 2013 137