Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-Cell lymphoma

Cancer

Volumn 121, Issue 5, 2015, Pages 716-723

  Toumishey, Ethan ^a   Prasad, Angeli ^b   Dueck, Greg ^c   Chua, Neil ^b   Finch, Daygen ^c   Johnston, James ^d   Van Der Jagt, Richard ^e   Stewart, Doug ^f   White, Darrell ^a   Belch, Andrew ^b   Reiman, Tony ^a,g  

^a DALHOUSIE UNIVERSITY   (Canada)

^b UNIVERSITY OF ALBERTA   (Canada)

^c BRITISH COLUMBIA CANCER AGENCY   (Canada)

^d UNIVERSITY OF MANITOBA   (Canada)

^e UNIVERSITY OF OTTAWA   (Canada)

^f UNIVERSITY OF CALGARY   (Canada)

^g UNIVERSITY OF NEW BRUNSWICK   (Canada)

Author keywords

Immunomodulation; Lenalidomide; Phase 2 clinical trial; T cell lymphoma

Indexed keywords

LENALIDOMIDE; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; IMMUNOLOGIC FACTOR; THALIDOMIDE;

ACUTE HEART INFARCTION; ADULT; AGED; ALLERGIC REACTION; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLEEDING; CANCER CHEMOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COGNITIVE DEFECT; CONSCIOUSNESS DISORDER; CONSTIPATION; COUGHING; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRY SKIN; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FLU LIKE SYNDROME; GOUT; HEART ARRHYTHMIA; HEART MUSCLE ISCHEMIA; HEART SUPRAVENTRICULAR ARRHYTHMIA; HUMAN; HYPERTENSION; HYPOXIA; INFECTION; INSOMNIA; KIDNEY FAILURE; LEG EDEMA; LUNG DISEASE; LYMPHOCYTOPENIA; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; MUSCLE WEAKNESS; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RASH; RESPIRATORY FAILURE; RIGOR; SEIZURE; SMALL INTESTINE OBSTRUCTION; SURVIVAL TIME; T CELL LYMPHOMA; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT OUTCOME; TUMOR FLARE; VOMITING; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG EFFECTS; IMMUNOMODULATION; LYMPHOMA, T-CELL, PERIPHERAL; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; REMISSION; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOMODULATION; LYMPHOMA, T-CELL, PERIPHERAL; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; REMISSION INDUCTION; THALIDOMIDE;

EID: 84923279634     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.29103     Document Type: Article

References (35)

1. Dueck G, Chua N, Prasad A, et al. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010; 116:4541-4548.
2. Lunning MA, Moskowitz AJ, Horwitz S. Strategies for relapsed peripheral T-cell lymphoma: the tail that wags the curve. J Clin Oncol. 2013; 31:1922-1927.
3. Mak V, Hamm J, Chhanabhai M, et al. Survival of patients with peripheral T-cell lymphoma after first relapse or progression: spectrum of disease and rare long-term survivors. J Clin Oncol. 2013; 31:1970-1976.
4. Savage KJ, Reiman T. Peripheral T-cell lymphomas: progress and challenges. Oncology Exchange. 2012; 11:10-18.
5. Baz R, Patel M, Finley-Oliver E, et al. Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis. Leuk Lymphoma. 2010; 51:1015-1019.
6. Chen CI, Bergsagel PL, Paul H, et al. Single-agent lenalidomide in the treatment of previously untreated chronic lymphocytic leukemia. J Clin Oncol. 2011; 29:1175-1181.
7. Morschhauser F, Fitoussi O, Haioun C, et al. A phase 2, multi-centre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013; 49:2869-2876.
8. Zinzani PL, Pellegrini C, Broccoli A, et al. Lenalidomide monotherapy for relapsed/refractory peripheral T-cell lymphoma not otherwise specified. Leuk Lymphoma. 2011; 52:1585-1588.
9. Witzig TE, Vose JM, Zinzani PL, et al. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011; 22:1622-1627.
10. Eve HE, Carey S, Richardson SJ, et al. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012; 159:154-163.
11. Corral LG, Haslett PA, Muller GW, et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999; 163:380-386.
12. Dredge K, Marriott JB, Todryk SM, et al. Protective antitumor immunity induced by a costimulatory thalidomide analog in conjunction with whole tumor cell vaccination is mediated by increased Th1-type immunity. J Immunol. 2002; 168:4914-4919.
13. Ramsay AG, Clear AJ, Kelly G, et al. Follicular lymphoma cells induce T-cell immunologic synapse dysfunction that can be repaired with lenalidomide: implications for the tumor microenvironment and immunotherapy. Blood. 2009; 114:4713-4720.
14. Reddy N, Hernandez-Ilizaliturri FJ, Deeb G, et al. Immunomodulatory drugs stimulate natural killer-cell function, alter cytokine production by dendritic cells, and inhibit angiogenesis enhancing the anti-tumour activity of rituximab in vivo. Br J Haematol. 2008; 140:36-45.
15. Zhu D, Corral LG, Fleming YW, Stein B. Immunomodulatory drugs Revlimid (lenalidomide) and CC-4047 induce apoptosis of both hematological and solid tumor cells through NK cell activation. Cancer Immunol Immunother. 2008; 57:1849-1859.
16. Dredge K, Horsfall R, Robinson SP, et al. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005; 69:56-63.
17. Lu G, Middleton RE, Sun H, et al. The myeloma drug lenalidomide promotes the cereblon-dependent destruction of Ikaros proteins. Science. 2014; 343:305-309.
18. Kronke J, Udeshi ND, Narla A, et al. Lenalidomide causes selective degradation of IKZF1 and IKZF3 in multiple myeloma cells. Science. 2014; 343:301-305.
19. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999; 17:1244-1253.
20. Coiffier B, Pro B, Prince HM, et al. Results from a pivotal, openlabel, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012; 30:631-636.
21. Advani R, Hymes K, Pohlman B, et al. Belinostat (PXD101) in patients with recurrent or refractory peripheral or cutaneous T-cell lymphoma: results of a phase II study. Blood. 2007; 110:3453.
22. O'Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011; 29:1182-1189.
23. Dang NH, Pro B, Hagemeister FB, et al. Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma. Br J Haematol. 2007; 136:439-447.
24. Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014; 123:3095-3100.
25. Damaj G, Gressin R, Bouabdallah K, et al. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013; 31:104-110.
26. Friedberg JW, Mahadevan D, Cebula E, et al. Phase II study of alisertib, a selective Aurora A kinase inhibitor, in relapsed and refractory aggressive B- and T-cell non-Hodgkin lymphomas. J Clin Oncol. 2014; 32:44-50.
27. Chaoui D, Bouallegue S, Arakelyan N, Genet P, Aljijakli A, Sutton L. Bortezomib, lenalidomide and dexamethasone (VRD) combination as salvage therapy in refractory angioimmunoblastic T cell lymphoma. Br J Haematol. 2014; 164:750-752.
28. Hopfinger G, Melchardt T, Weiss L, et al. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014; 93:459-462.
29. Zhu YX, Kortuem KM, Stewart AK. Molecular mechanism of action of immune-modulatory drugs thalidomide, lenalidomide and pomalidomide in multiple myeloma. Leuk Lymphoma. 2013; 54:683-687.
30. Broccoli A, Pellegrini C, Celli M, et al. Single-agent lenalidomide is effective in the treatment of a heavily pretreated and refractory angioimmunoblastic T-cell lymphoma patient. Clin Lymphoma Myeloma Leuk. 2014; 14:e119-e122.
31. Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008; 26:4124-4130.
32. Federico M, Rudiger T, Bellei M, et al. Clinicopathologic characteristics of angioimmunoblastic T-cell lymphoma: analysis of the international peripheral T-cell lymphoma project. J Clin Oncol. 2013; 31: 240-246.
33. Sviggum HP, Davis MD, Rajkumar SV, Dispenzieri A. Dermatologic adverse effects of lenalidomide therapy for amyloidosis and multiple myeloma. Arch Dermatol. 2006; 142:1298-1302.
34. Wiernik PH, Lossos IS, Tuscano JM, et al. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008; 26:4952-4957.
35. Richardson PG, Weller E, Lonial S, et al. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood. 2010; 116:679-686.