Lenalidomide plus rituximab as initial treatment for mantle-cell Lymphoma

New England Journal of Medicine

Volumn 373, Issue 19, 2015, Pages 1835-1844

  Ruan, Jia ^a   Martin, Peter ^a   Shah, Bijal ^b   Schuster, Stephen J ^c   Smith, Sonali M ^d   Furman, Richard R ^a   Christos, Paul ^a   Rodriguez, Amelyn ^a   Svoboda, Jakub ^c   Lewis, Jessica ^a   Katz, Orel ^a   Coleman, Morton ^a   Leonard, John P ^a  

^a NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LENALIDOMIDE; RITUXIMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; THALIDOMIDE;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BASAL CELL CARCINOMA; CELLULITIS; CHOLANGITIS; CLINICAL ARTICLE; CONSTIPATION; COUGHING; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; HYPERGLYCEMIA; HYPOTHYROIDISM; INFLAMMATION; INFUSION RELATED REACTION; MALE; MANTLE CELL LYMPHOMA; MELANOMA; MERKEL CELL TUMOR; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RASH; RISK ASSESSMENT; SERUM SICKNESS; SIDE EFFECT; SINUSITIS; SKIN CARCINOMA; THROMBOCYTOPENIA; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VERY ELDERLY; VIRUS ENCEPHALITIS; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; FOLLOW UP; INDUCTION CHEMOTHERAPY; INTENTION TO TREAT ANALYSIS; LYMPHOMA, MANTLE-CELL; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; MORTALITY; SURVIVAL;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; EXANTHEMA; FEMALE; FOLLOW-UP STUDIES; HUMANS; INDUCTION CHEMOTHERAPY; INTENTION TO TREAT ANALYSIS; LYMPHOMA, MANTLE-CELL; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; NEUTROPENIA; QUALITY OF LIFE; SURVIVAL ANALYSIS; THALIDOMIDE;

EID: 84946616176     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1505237     Document Type: Article

References (30)

1. Pérez-Galán P, Dreyling M, Wiestner A. Mantle cell lymphoma: Biology, pathogenesis, and the molecular basis of treatment in the genomic era. Blood 2011; 117: 26-38.
2. Herrmann A, Hoster E, Zwingers T, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol 2009; 27: 511-8.
3. Campo E, Rule S. Mantle cell lymphoma: Evolving management strategies. Blood 2015; 125: 48-55.
4. Martin P, Chadburn A, Christos P, et al. Outcome of deferred initial therapy in mantle-cell lymphoma. J Clin Oncol 2009; 27: 1209-13.
5. Howard OM, Gribben JG, Neuberg DS, et al. Rituximab and CHOP induction therapy for newly diagnosed mantle-cell lymphoma: Molecular complete responses are not predictive of progression-free survival. J Clin Oncol 2002; 20: 1288-94.
6. Lenz G, Dreyling M, Hoster E, et al. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-Term outcome in patients with previously untreated mantle cell lymphoma: Results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol 2005; 23: 1984-92.
7. Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: An open-label, multicentre, randomised, phase 3 noninferiority trial. Lancet 2013; 381: 1203-10.
8. Romaguera JE, Fayad L, Rodriguez MA, et al. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol 2005; 23: 7013-23.
9. Geisler CH, Kolstad A, Laurell A, et al. Long-Term progression-free survival of mantle cell lymphoma after intensive frontline immunochemotherapy with in vivopurged stem cell rescue: A nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood 2008; 112: 2687-93.
10. Delarue R, Haioun C, Ribrag V, et al. CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: A phase 2 study from the Groupe d'Etude des Lymphomes de l'Adulte. Blood 2013; 121: 48-53.
11. Abrahamsson A, Albertsson-Lindblad A, Brown PN, et al. Real world data on primary treatment for mantle cell lymphoma: A Nordic Lymphoma Group observational study. Blood 2014; 124: 1288-95.
12. Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer 2004; 4: 314-22.
13. 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.
14. Song K, Herzog BH, Sheng M, et al. Lenalidomide inhibits lymphangiogenesis in preclinical models of mantle cell lymphoma. Cancer Res 2013; 73: 7254-64.
15. Moros A, Bustany S, Cahu J, et al. Antitumoral activity of lenalidomide in in vitro and in vivo models of mantle cell lymphoma involves the destabilization of cyclin D1/p27KIP1 complexes. Clin Cancer Res 2014; 20: 393-403.
16. Zhang L, Qian Z, Cai Z, et al. Synergistic antitumor effects of lenalidomide and rituximab on mantle cell lymphoma in vitro and in vivo. Am J Hematol 2009; 84: 553-9.
17. Chong EA, Ahmadi T, Aqui NA, et al. Combination of lenalidomide and rituximab overcomes rituximab resistance in patients with indolent B-cell and mantle cell lymphomas. Clin Cancer Res 2015; 21: 1835-42.
18. Ahmadi T, Chong EA, Gordon A, et al. Combined lenalidomide, low-dose dexamethasone, and rituximab achieves durable responses in rituximab-resistant indolent and mantle cell lymphomas. Cancer 2014; 120: 222-8.
19. Goy A, Sinha R, Williams ME, 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 2013; 31: 3688-95.
20. Trneny M, Lamy T, Walewski J, et al. Phase II randomized, multicenter study of lenalidomide vs best investigator's choice in relapsed/refractory mantle cell lymphoma: Results of the MCL-002 (SPRINT) study. Blood 2014; 124: 626. abstract.
21. Wang M, Fayad L, Wagner-Bartak N, et al. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: A phase 1/2 clinical trial. Lancet Oncol 2012; 13: 716-23.
22. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007; 25: 579-86.
23. Smith SK, Zimmerman S, Williams CS, Zebrack BJ. Health status and quality of life among non-Hodgkin lymphoma survivors. Cancer 2009; 115: 3312-23.
24. Harrison CN, Mesa RA, Kiladjian JJ, et al. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol 2013; 162: 229-39.
25. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
26. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle-cell lymphoma. N Engl J Med 2012; 367: 520-31.
27. Robak T, Huang H, Jin J, et al. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med 2015; 372: 944-53.
28. Till BG, Li H, Bernstein SH, et al. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for previously untreated mantle cell lymphoma: SWOG 0601. Blood 2014; 124: 149. abstract.
29. Forstpointner R, Unterhalt M, Dreyling M, et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood 2006; 108: 4003-8.
30. Chang JE, Li H, Smith MR, et al. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: An Eastern Cooperative Oncology Group study (E1405). Blood 2014; 123: 1665-73.