Lenalidomide: The emerging role of a novel targeted agent in malignancies

Drugs of Today

Volumn 43, Issue 2, 2007, Pages 85-95

  Kalmadi, Sujith ^a   Baz, Rachid ^a   Mahindra, Anuj ^a  

^a TAUSSIG CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ACICLOVIR; AMOXICILLIN; AZACITIDINE; DOCETAXEL; DOXORUBICIN; ERYTHROPOIETIN; INTERLEUKIN 6; LENALIDOMIDE; TUMOR NECROSIS FACTOR ALPHA; VASCULOTROPIN; VINCRISTINE;

ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BLOOD TOXICITY; BLOOD TRANSFUSION; BONE MARROW SUPPRESSION; CHEMICAL TERATOGENESIS; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DEEP VEIN THROMBOSIS; DIARRHEA; DRUG ABSORPTION; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG INHIBITION; DRUG MECHANISM; DRUG METABOLISM; DRUG TARGETING; DRUG TOLERABILITY; FATIGUE; HUMAN; IMMUNOMODULATION; LEUKOPENIA; LUNG EMBOLISM; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; NONHODGKIN LYMPHOMA; NONHUMAN; PATIENT MONITORING; PREGNANCY; PRURITUS; REVIEW; SKIN TOXICITY; SOLID TUMOR; T LYMPHOCYTE ACTIVATION; THROMBOCYTOPENIA; THROMBOEMBOLISM; THROMBOSIS; THROMBOSIS PREVENTION;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE II; HUMANS; MULTIPLE MYELOMA; MYELODYSPLASTIC SYNDROMES; NEOPLASMS; THALIDOMIDE;

EID: 34147203758     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2007.43.2.1037480     Document Type: Review

References (49)

1. Sheskin, J. Thalidomide in the treatment of lepra reactions. Clin Pharmacol Ther 1965, 6: 303-6.
2. Marriott, J.B., Muller, G., Stirling, D., Dalgleish, A.G. Immunotherapeutic and antitumour potential of thalidomide analogues. Expert Opin Biol Ther 2001, 1: 675-82.
3. Bartlett, J.B., Dredge, K., Dalgleish, A.G. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer 2004, 4: 314-22.
4. Corral, L.G., Kaplan, G. Immunomodulation by thalidomide and thalidomide analogues. Ann Rheum Dis 1999, 58 (Suppl. 1): I107-13.
5. Ruegg, C., Yilmaz, A., Bieler, G., Bamat, J., Chaubert, P., Lejeune, F.J. Evidence for the involvement of endothelial cell integrin alphaV-beta3 in the disruption of the tumor vasculature induced by TNF and IFN-gamma. Nat Med 1998, 4: 408-14.
6. Corral, L.G., Muller, G.W., Moreira, A.L. et al. Selection of novel analogs of thalidomide with enhanced tumor necrosis factor alpha inhibitory activity. Mol Med 1996, 2: 506-15.
7. Haslett, P.A., Corral, L.G., Albert, M., Kaplan, G. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med 1998, 187: 1885-92.
8. Geitz, H., Handt, S., Zwingenberger, K. Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopharmacology 1996, 31: 213-21.
9. Richardson, P.G., Schlossman, R.L, Weller, E. et al. Immunomodulatory, drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood 2002, 100: 3063-7.
10. Gupta, D., Treon, S.P., Shima, Y. et al. Adherence of multiple myeloma cells to bone marrow stromal cells upregulates vascular endothelial growth factor secretion: Therapeutic applications. Leukemia 2001, 15: 1950-61.
11. Hideshima, T., Chauhan, D., Shima, Y. et al. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood 2000, 96: 2943-50.
12. Dredge, K., Marriott, J.B., Macdonald, C.D. et al. Novel thalidomide analogues display anti-angiogenic activity independently of immunomodulatory effects. Br J Cancer 2002, 87: 1166-72.
13. Corral, L.G., Haslett, P.A., Muller, G.W. 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: 380-6.
14. Revlimio® product insert, 2006. Accessed at http://www.revlimid.com/pdf/REVLIMID_PI.pdf.
15. Baz, R., Li, L., Kottke-Marchant, K. et al. The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc 2005, 80: 1568-74.
16. Silverman, L.R., Demakos, E.P., Peterson, B.L. et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: A study of the cancer and leukemia group B. J Clin Oncol 2002, 20: 2429-40.
17. Raza, A., Meyer, P., Dutt, D. et al. Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. Blood 2001, 98: 958-65.
18. Raza, A., Gezer, S., Mundle, S. et al. Apoptosis in bone marrow biopsy samples involving stromal and hematopoietic cells in 50 patients with myelodysplastic syndromes. Blood 1995, 86: 268-76.
19. Eriksson, U., Alitalo, K. VEGF receptor 1 stimulates stem-cell recruitment and new hope for angiogenesis therapies. Nat Med 2002, 8: 775-7.
20. Stifter, G., Heiss, S., Gastl, G., Tzankov, A., Stauder, R. Over-expression of tumor necrosis factor-alpha in bone marrow biopsies from patients with myelodysplastic syndromes: Relationship to anemia and prognosis. Eur J Haematol 2005, 75: 485-91.
21. Shetty, V., Mundle, S., Alvi, S. et al. Measurement of apoptosis, proliferation and three cytokines in 46 patients with myelodysplastic syndromes. Leuk Res 1996, 20: 891-900.
22. List, A., Kurtin, S., Roe, D.J. et al. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med 2005, 352: 549-57.
23. Greenberg, P., Cox, C, LeBeau, M.M. et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997, 89: 2079-88.
24. Haase, D., Steidl, C, Schanz, J. et al. Correlation of cytogenetic findings with morphology, clinical course and prognosis in 2,124 patients with MDS. Blood 2005, 106: Abst. 787.
25. List, A., Dewald, G., Bennett, J. et al. Clinical benefit from 2 phase II trials evaluating lenalidomide (Revlmid®,) in lower risk myelodysplas-tic syndrome patients with or without del 5q cytogenetics abnormalities. Hematologica 2006, 91: 379, Abst. 1032.
26. List, A., Dewald, G., Bennett, J. et al. Long-term clinical benefit of lenalidomide (Revlmid®,) treatment in patients with myelodysplastic syndrome and chromosome deletion 5q. Blood 2006, 108: 11 (Abst. 251).
27. List, A., Dewald, G., Bennett, J. et al. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 2006, 355: 1456-65.
28. Buesche, G., Dieck, S., Giagounidis, A. et al. Anti-angiogenic in vivo effect of lenalidomide (CC-5013) in myelodysplastic syndrome with del(5q) chromosome abnormality and its relation to the course of disease. Blood 2005, 106: Abst. 372.
29. Rajkumar, S.V., Blood, E., Vesole, D., Fonseca, R., Greipp, P.R. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: A clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol 2006, 24: 431-6.
30. Singhal, S., Mehta, J., Desikan, R. et al. Anti-tumor activity of thalidomide in refractory multiple myeloma. N Engl J Med 1999, 341: 1565-71.
31. Richardson, P.G., Jagannath, S., Schlossman, R. et al. A multicenter, randomized, phase 2 study to evaluate the efficacy and safety of 2 CDC-5013 dose regimens when used alone or in combination with dexamethasone (Dex) for the treatment of relapsed or refractory multiple myeloma (MM). Blood 2003, 102: Abst. 825.
32. Weber, D., Chen, C, Niesvizky, R. et al. Lenalidomide plus high-dose dexamethasone provides improved overall survival compared to high-dose dexamethasone alone for relapsed or refractory multiple myeloma (MM): Results of a North American phase III study (MM-009). J Clin Oncol 2006, 24: Abst. 7521.
33. Dimopoulos, M., Spencer, A., Prince, M. et al. Study of lenalidomide plus dexamethasone versus dexamethasone alone in relapsed or refractory multiple myeloma (MM): Results of a phase 3 study (MM-010). Blood 2005, 106: Abst. 6.
34. Wang, M., Knight, R., Dimopoulos, M. et al. Comparison of lenalidomide in combination with dexamethasone to dexamethasone alone in patients who have received prior thalidomide in relapsed or refractory multiple myeloma. J Clin Oncol 2006, 24: Abst. 7522.
35. Stadtmauer, E., Weber, D., Dimopoulos, M. et al. Lenalidomide (Len) in combination with dexamethasone (Dex) is more effective than Dex alone at first relapse and provides better outcomes when used early rather than as later salvage therapy in relapsed multiple myeloma (MM). J Clin Oncol 2006, 24: Abst. 7600.
36. Baz, R., Choueiri, T.K., Abou Jawde, R. et al. Doxil (D), vincristine (V), reduced frequency dexamethasone (d) and Revlimid® (DVd-R) results in a high response rate in patients with refractory multiple myeloma (RMM). Blood 2005, 106: Abst. 2559.
37. Richardson, P., Schlossman, R., Munshi, N. et al. A phase 1 trial of lenalidomide (Revlimid®,) with bortezomib (Velcade®) in relapsed and refractory multiple myeloma. Blood 2005, 106: Abst. 365.
38. Palumbo, A., Falco, P., Benevolo, G. et al. Oral lenalidomide plus melphalan and prednisone (R-MP) for newly diagnosed multiple myeloma. J Clin Oncol 2006, 24: Abst. 7518.
39. Niesvizky, R., Pekle, K., Gelbshtein, U. et al. BIRD (Biaxin®/Revlimid®/Dexamethasone) combination therapy (Rx) results in high complete remissions (CR) and overall responses in myeloma (MM) with poor prognostic features. Blood 2005, 106: Abst. 642.
40. Rajkumar, S.V., Hayman, S.R., Lacy, M.Q. et al. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood 2005, 106: 4050-3.
41. Chanan-Khan, A., Miller, K., DiMiceli, L. et al. Results of phase II study of lenalidomide (L) (Revlimicr®) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Blood 2005, 206: Abst. 447.
42. DiMiceli, L., Miller, K., Rickert, M. et al. Characterization of IMiDs (immunomodulating agents) induced "Flare reaction" in patients with chronic lymphocytic leukemia (CLL) and correlation with changes in serum cytokine levels. Blood 2005, 206: Abst. 5049.
43. Dispenzieri, A., Lacy, M., Zeldenrust, S. et al. Lenalidomide has activity in a phase II trial in patients with primary systemic amyloidosis. Blood 2005, 206: Abst. 252.
44. Querfeld, C., Kuzel, T., Guitart, J., Rosen, S. Preliminary results of a phase II study of CC-5013 (Lenalidomide, Revlimid®) in patients with cutaneous T-cell lymphoma. Blood 2005, 206: Abst. 3351.
45. Kalmadi, S.M. Davis, A. Dowlati, S. et al. Phase I trial of docetaxel, carboplatin and lenalidomide in patients with advanced solid tumors. ASCO 2006, Atlanta 2006, Abst. 13027.
46. Bartlett, J.B., Michael, A., Clarke, I.A. et al. Phase I study to determine the safety, tolerability and immunostimulatory activity of thalidomide analogue CC-5013 in patients with metastatic malignant melanoma and other advanced cancers. Br J Cancer 2004, 90: 955-61.
47. Marsh, L., Khan, M., Needle, M., Amato, R. Phase II study of lenalidomide in patients with metastatic renal cell cancer. ASCO 2006, Atlanta 2006, Abst. 4533.
48. Choueiri, T., Dreicer, R., Rini, B. et al. Phase II study of lenalidomide in pts with metastatic renal cell carcinoma. ASCO, Atlanta 2006, Abst. 4539.
49. Papadopoulos, K., Mendelson, D., Preston, G. et al. A phase I study of lenalidomide and weekly docetaxel in patients with advanced solid tumors. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2005, Philadelphia 2005, Abst. C71.