Thalidomide: Current and potential clinical applications

American Journal of Medicine

Volumn 108, Issue 6, 2000, Pages 487-495

  Calabrese, Leonard ^a   Fleischer Jr , Alan B ^b  

^a LERNER RESEARCH INSTITUTE   (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

THALIDOMIDE; TUMOR NECROSIS FACTOR ALPHA;

ANGIOGENESIS; ANTIINFLAMMATORY ACTIVITY; DIARRHEA; DRUG ACTIVITY; ERYTHEMA; ERYTHEMA NODOSUM LEPROSUM; GRAFT VERSUS HOST REACTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOMODULATION; KAPOSI SARCOMA; MULTIPLE MYELOMA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SKIN DISEASE; TERATOGENICITY;

ANGIOGENESIS INHIBITORS; ANTI-HIV AGENTS; ARTHRITIS, RHEUMATOID; BEHCET SYNDROME; DERMATOLOGIC AGENTS; ECTROMELIA; ERYTHEMA NODOSUM; GRAFT VS HOST DISEASE; HIV INFECTIONS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LEPROSTATIC AGENTS; LEPROSY, LEPROMATOUS; LUPUS ERYTHEMATOSUS, CUTANEOUS; NEOPLASMS; PERIPHERAL NERVOUS SYSTEM DISEASES; STOMATITIS, APHTHOUS; TERATOGENS; THALIDOMIDE;

EID: 0034655161     PISSN: 00029343     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9343(99)00408-8     Document Type: Review

References (96)

1. Faure M., Thivolet J., Gaucherand M. Inhibition of PMN leukocytes chemotaxis by thalidomide. Arch Dermatol Res. 269:1980;275-280.
2. Geitz H., Handt S., Zwingerberger K. Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopharmacology. 1996;l31:213-l31:221.
3. Barnhill R.L., Doll N.J., Millikan L.E., et al. Studies on the anti-inflammatory properties of thalidomide effects on polymorphonuclear leukocytes and monocytes . J Am Acad Dermatol. 11:1984;814-819.
4. Sampaio E.P., Sarno E.N., Galilly R., et al. Thalidomide selectively inhibits tumor necrosis factor α production by stimulated human monocytes. J Exp Med. 173:1991;699-703.
5. Moriera A.L., Sampaio E.P., Zmuidzinas A., et al. Thalidomide exerts its inhibitory action on tumor necrosis factor α by enhancing mRNA degradation. J Exp Med. 177:1993;1675-1680.
6. Klausner J.D., Freedman V.H., Kaplan G. Thalidomide as an anti-TNF-α inhibitor implications for clinical use . Clin Immunol Immunopathol. 81:1996;219-223.
7. Sampaio E.P., Moriera A.L., Sarno E.N., et al. Prolonged treatment with recombinant interferon γ induces erythema nodosum leprosum in lepromatous leprosy patients. J Exp Med. 175:1992;1729-1737.
8. Sarno E.N., Grau G.E., Vieira L.M.M., Nery J.A. Serum levels of tumor necrosis factor-alpha and interleukin-1β during leprosy reactional states. Clin Exp Immunol. 84:1991;103-108.
9. Sampaio E.P., Kaplan G., Miranda A., et al. The influence of thalidomide on the clinical and immunologic manifestation of erythema nodosum leprosum. J Infect Dis. 168:1993;408-414.
10. Jacobson J.M., Greenspan J.S., Spritzler J., et al. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. NEJM. 336:1997;1487-1493.
11. Wolkenstein P., Latarject J., Roujeau J.C. Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis. Lancet. 352:1998;1586-1589.
12. Strieter R.M., Kunkel S.J., Bone R.C. Role of tumor necrosis factor-α in disease states and inflammation. Crit Care Med. 21:1993;S447-S463.
13. Davidsen S.K., Summers J.B. Inhibitors of TNFα synthesis. Exp Opin Ther Patents. 5:1995;1087-1100.
14. Gad S.M., Shannon E.J., Krotoski W.A., et al. Thalidomide induces imbalances in T-lymphocyte sub-populations in the circulating blood of healthy males. Lepr Rev. 56:1985;35-39.
15. McHugh S.M., Rifkin I.R., Deighton J., et al. The immunosuppressive drug thalidomide induces T helper cell type 2 (Th2) and concomitantly inhibits Th1 cytokine production in mitogen- and antigen-stimulated human peripheral blood mononuclear cell cultures. Clin Exp Immunol. 99:1995;160-167.
16. Shannon E.J., Sandoval F. Thalidomide increases the synthesis of IL-2 in cultures of human mononuclear cells stimulated with Concanavalin-A, staphylococcal enterotoxin A, and purified protein derivative. Immunopharmacology. 31:1995;109-116.
17. Moller D.R., Wysocka M., Greenlee B.M., et al. Inhibition of IL-12 production by thalidomide. J Immunol. 159:1997;5157-5161.
18. Haslett P.A., Corral L.G., Albert M., Kaplan G. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytoxic responses in the CD8+ subset. J Exp Med. 187:1998;1885-1892.
19. D'Amato R.J., Loughnan M.S., Flynn E., Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci USA. 91:1994;4082-4085.
20. Verheul H.M., Panigrahy D., Yuan J., D'Amato R.J. Combination therapy with thalidomide and sulindac inhibits tumour growth in rabbits. Br J Cancer. 79:1999;114-118.
21. Sheskin J. Thalidomide in the treatment of lepra reactions. Clin Pharmacol Ther. 6:1965;303-306.
22. Iyer C.G.S., Languillon J., Ramanujam K., et al. WHO co-ordinated short-term double-blind trial with thalidomide in the treatment of acute lepra reactions in male lepromatous patients. Bull World Health Org. 45:1971;719-732.
23. THALOMID [package insert]. Warren, NJ; Celgene Corporation., 1998.
24. Hastings R.C., Trautman J.R., Enna C.D., Jacobson R.R. Thalidomide in the treatment of erythema nodosum leprosum. With a note on selected laboratory abnormalities in erythema nodosum leprosum. Clin Pharmacol Ther. 11:1970;481-487.
25. Mascaro J.M., Lecha M., Torras H. Thalidomide in the treatment of recurrent, necrotic, and giant mucocutaneous aphthae and aphthosis. Arch Dermatol. 115:1979;636-637.
26. Torras H, Lecha M, Mascaro J. Thalidomide treatment of recurrent necrotic giant mucocutaneous aphthae and aphthosis. Arch Dermatol 1982;118:875. Letter.
27. Grinspan D. Significant response of oral aphthosis to thalidomide treatment. J Am Acad Dermatol. 12:1985;85-90.
28. Revuz J., Guillaume J.-C., Janier M., et al. Crossover study of thalidomide versus placebo in severe recurrent aphthous stomatitis. Arch Dermatol. 126:1990;923-927.
29. Bonnetblanc J.M., Royer C., Bedane C. Thalidomide and recurrent aphthous stomatitis a follow-up study . Dermatology. 193:1996;321-323.
30. Jorizzo J.L., Schmalstieg F.C., Solomon A.R., et al. Thalidomide effects in Behçet's syndrome and pustular vasculitis. Arch Intern Med. 146:1986;878-881.
31. Saylan T, Saltik I. Thalidomide in the treatment of Behçet's syndrome. Arch Dermatol 1982;118:536. Letter.
32. Hamza M. Behçet's disease, palmoplantal pustolosis and HLA-B27 treatment with thalidomide. Clin Exp Rheumatol 1990;8:427. Letter.
33. Hamuryudan V., Mat C., Saip S., et al. Thalidomide in the treatment of the mucocutaneous lesions of Behçet's syndrome a randomized, double-blind, placebo controlled trial . Ann Intern Med. 128:1998;443-459.
34. Knop J., Bonsmann G., Happle R., et al. Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus. Br J Dermatol. 108:1983;461-466.
35. Stevens R.J., Andujar C., Edwards C.J., et al. Thalidomide in the treatment of the cutaneous manifestations of lupus erythematosus experience in sixteen consecutive patients . Br J Rheumatol. 36:1997;353-359.
36. Bessis D, Guillot B, Monpoint S, et al. Thalidomide for systemic lupus erythematosis. Lancet 1992;339:549-550. Letter.
37. Atra E., Sato E.I. Treatment of the cutaneous lesions of systemic lupus erythematosus with thalidomide. Clin Exp Rheumatol. 11:1993;487-493.
38. van den Broek H. Treatment of prurigo nodularis with thalidomide. Arch Dermatol. 116:1980;571-572.
39. Ferrándiz C., Carrascosa J.M., Just M., et al. Sequential combined therapy with thalidomide and narrow-band (TL01) UVB in the treatment of prurigo nodularis. Dermatology. 195:1997;359-361.
40. Sheskin J. Zur Therapie der prurigo nodularis hyde mit thalidomid. Der Hautarzt 1975;26:215-217.
41. Winkelmann R.K., Connolly S.M., Doyle J.A., Padilha-Goncalves A. Thalidomide treatment of prurigo nodularis. Acta Derm Venereol. 64:1984;412-417.
42. Maurer TA, Poncelet A, Badger J, Berger TG. Thalidomide for the treatment of prurigo nodularis of HIV-infected patients. In: Program and abstracts of the XI International Conference on AIDS, July 7-12, 1996, Vancouver, British Columbia. Abstract Tu.B.2274.
43. Radeff B., Kuffer R., Samson J. Recurrent aphthous ulcer in patient infected with human immunodeficiency virus successful treatment with thalidomide . J Am Acad Dermatol. 23:1990;523-525.
44. Naum S.M., Molloy P.J., Kania R.J., et al. Use of thalidomide in treatment and maintenance of idiopathic esophageal ulcers in HIV+ individuals. Dig Dis Sci. 40:1995;1147-1148.
45. Ball S.C., Sepkowitz K.A., Jacobs J.L. Thalidomide for treatment of oral aphthous ulcers in patients with human immunodeficiency virus case report and review . Am J Gastroenterol. 92:1997;169-170.
46. Youle M., Clarbour J., Farthing C., et al. Treatment of resistant aphthous ulceration with thalidomide in patients positive for HIV antibody. BMJ. 298:1989;432.
47. Ghigliotti G., Reoetto T., Farris A., et al. Thalidomide. Treatment of choice for aphthous ulcers in patients seropositive for human immunodeficiency virus. J Am Acad Dermatol. 28:1993;271-272.
48. DeVincenzo J.P., Burchet S.K. Prolonged thalidomide therapy for human immunodeficiency virus-associated recurrent severe esophageal and oral aphthous ulcers. Pediatr Infect Dis J. 15:1996;465-467.
49. Paterson D.L., Georghiou P.R., Allworth A.M., Kemp R.J. Thalidomide as treatment of refractory aphthous ulceration related to human immunodeficiency virus infection. Clin Infect Dis. 20:1995;250-254.
50. Ryan J, Colman J, Pedersen J, Benson E. Thalidomide to treat esophageal ulcer in AIDS. NEJM 1992;327:208-209. Letter.
51. MacRedmond R, Keating S, Armstrong S, et al. The use of oral thalidomide in the treatment of esophageal ulceration in AIDS. AIDS 1996;10(suppl 2):S44. Abstract.
52. Alexander L.N., Wilcox C.M. A prospective trial of thalidomide for the treatment of HIV-associated idiopathic esophageal ulcers. AIDS Res Hum Retroviruses. 13:1997;301-304.
53. Grunfeld C., Feingold K.R. Metabolic disturbances and wasting in the acquired immunodeficiency syndrome. NEJM. 327:1992;329-337.
54. Reyes-Terán G., Sierra-Madero J.G., Martinez del Cerro V., et al. Effects of thalidomide on HIV-associated wasting syndrome a randomized, double-blind, placebo-controlled clinical trial . AIDS. 10:1996;1501-1507.
55. Haslett P., Hempstead M., Seidman C., et al. The metabolic and immunologic effects of short-term thalidomide treatment of patients infected with the human immunodeficiency virus. AIDS Res Hum Retroviruses. 13:1997;1047-1054.
56. Kaplan G, Schambelan M, Gottlieb M, et al. Thalidomide reverses cachexia in HIV-wasting syndrome. 5th Conference on Retroviruses and Opportunistic Infections, Chicago, IL, 1998: Abstract 476.
57. Sharpstone D.R., Rowbottom A.W., Nelson M.R., et al. Faecal tumor necrosis factor-α in individuals with HIV-related diarrhea. AIDS. 10:1996;989-994.
58. Sharpstone D., Rowbottom A., Nelson N.M., Gazzard B. The treatment of microsporidial diarrhea with thalidomide. AIDS. 9:1995;658-659.
59. Quinones F, Sierra-Madero J, Calva-Mercado JJ, Ruiz-Palacios GM. Thalidomide in patients with HIV infection, and chronic diarrhea. double blind placebo controlled clinical trial. 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, 1997. Abstract 682.
60. Makonkawkeyoon S., Limson-Pobre R.N.R., Moreira A.L., et al. Thalidomide inhibits the replication of human immunodeficiency virus type 1. Proc Natl Acad Sci USA. 90:1993;5974-5978.
61. Moreira A.L., Corral L.G., Ye W., et al. Thalidomide and thalidomide analogs reduce HIV type 1 replication in human macrophages in vitro. AIDS Res Hum Retroviruses. 13:1997;857-863.
62. Klausner J.D., Makonkawkeyoon S., Akarasewi P., et al. The effect of thalidomide on the pathogenesis of human immunodeficiency virus type 1 and M. tuberculosis infection. J Acquir Immune Defic Syndr Hum Retrovirol. 11:1996;247-257.
63. Kovacs J.A., Baseler M., Dewar R.J., et al. Increases in CD4 T lymphocytes with intermittent courses of interleukin-2 in patients with human immunodeficiency virus infection. NEJM. 332:1995;567-575.
64. Haslett PA, Klausner JD, Makonawkeyoon S, et al. Thalidomide treatment of HIV infected patients causes immune activation without increasing plasma viral burden. 5th Conference on Retroviruses and Opportunistic Infections, 1998, Chicago, IL. Abstract 606.
65. Saurat J-H, Camenzind M, Helg C, Chapuis B. Thalidomide for graft-versus-host disease after bone marrow transplantation. Lancet 1988;i:359. Letter.
66. Lim SH, McWhannell A, Vora AJ, Boughton BJ. Successful treatment with thalidomide of acute graft-versus-host disease after bone-marrow transplantation. Lancet 1988;i:117. Letter.
67. Heney D., Norfolk D.R., Wheeldon J., et al. Thalidomide treatment for chronic graft-versus-host disease. Br J Haematol. 78:1991;23-27.
68. Vogelsang G.B., Farmer E.R., Hess A.D., et al. Thalidomide for the treatment of chronic graft-versus-host disease. NEJM. 326:1992;1055-1058.
69. Chao N.J., Parker P.M., Niland J.C., et al. Paradoxical effect of thalidomide prophylaxis on chronic graft-vs.-host disease. Biol Blood Marrow Transplant. 2:1996;86-92.
70. Arend W.P., Dayer J.-M. Inhibition of the production and effects of interleukin-1 and tumor necrosis factor α in rheumatoid arthritis. Arthritis Rheum. 38:1995;151-160.
71. Gutiérrez-Rodríguez O., Starusta-Bacal P., Gutiérrez-Montes O. Treatment of rheumatoid arthritis the thalidomide experience . J Rheumatol. 16:1989;158-163.
72. Huizinga T.W.J., Dijkmans B.A.C., Van Der Velde E.A., et al. An open study of pentoxyfylline and thalidomide as adjuvant therapy in the treatment of rheumatoid arthritis. Ann Rheum Dis. 55:1996;833-836.
73. Grabstad H., Golbey R. Clinical experiences with thalidomide in patients with cancer. Clin Pharmacol Ther. 6:1965;298-302.
74. Olson K.B., Hall T.C., Horton J., et al. Thalidomide (N-phthaloylglutamide) in the treatment of advanced cancer. Clin Pharmacol Ther. 6:1965;292-297.
75. Solér R.A., Howard M., Brink N.S., et al. Regression of AIDS-related Kaposi's sarcoma during therapy with thalidomide. Clin Infect Dis. 23:1996;501-503.
76. Weller L, Little R, Wyvill K, et al. Preliminary results of phase II study of oral thalidomide in patients with HIV infection and Kaposi's sarcoma (KS). J Acquir Immune Defic Synd Hum Retrovirol 1997;14:A21. Abstract 20.
77. Bower M, Howard M, Gracie F, et al. A phase II study of thalidomide for Kaposi's sarcoma: activity and correlation with KSHV DNA load. J Acquir Immune Defic Synd Hum Retrovirol 1997;14:A35. Abstract 76.
78. Nguyen M., Tran C., Barsky S., et al. Thalidomide and chemotherapy combination preliminary results of preclinical and clinical studies . Int J Oncol. 10:1997;965-969.
79. Singhal S., Mehta J., Eddlemon P., et al. Marked anti-tumor effect from anti-angiogenesis (AA) therapy with thalidomide (T) in high risk refractory multiple myeloma. Blood. 92:(suppl 1 pt 2):1998;318a.
80. Barlogie B, Desikan R, Munshi N, et al. Single course D.T. PACE anti-angiochemotherapy effects CR in plasma cell leukemia and fulminant multiple myeloma. Blood 1998;92(suppl 1, pt 2):273b.
81. Long G, Vredenburgh J, Rizzieri DA, et al. Pilot trial of thalidomide post-autologous peripheral blood progenitor cell transplantation PBPC in patients with metastatic breast cancer. Proceedings of ASCO 1998;17:181a. Abstract 697.
82. Eisen T, Boshoff C, Vaughan MM, et al. Anti-angiogenic treatment of metastatic melanoma, renal cell, ovarian, and breast cancers with thalidomide. a phase II study. Proceedings of ASCO 1998;17:441a. Abstract 1699.
83. Figg WD, Bergan R, Brawley O, et al. Randomized phase II study of thalidomide in androgen-independent prostate cancer (AIPC). Proceedings of ASCO 1998;17:333a. Abstract 1189.
84. Fine HA, Loeffler JS, Kyritsis, et al. A phase II trial of the anti-angiogenic agent, thalidomide, in patients with recurrent high-grade gliomas. Proceedings of ASCO 1998;17:385a. Abstract 1372.
85. Mellin G., Katzenstein M. The saga of thalidomide (concluded). NEJM. 267:1962;1238-1244.
86. Neubert R, Neubert D. Peculiarities and possible mode of action of thalidomide. In: Kavlock RJ, Daston GP, eds. Drug Toxicity in Embryonic Development (Handbook of Experimental Pharmacology), vol.124/II. Berlin: Springer Verlag, 1996:41-119.
87. Zeldis JB, Williams BA, Thomas SD, Elsayed ME. S.T.E.P.S.: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther 1999;21:319-330.
88. Ochonisky S., Verroust J., Bastuji-Garin S., et al. Thalidomide neuropathy incidence and clinicoelectrophysiologic findings in 42 patients. Arch Dermatol. 130:1994;66-69.
89. Tseng S., Pak G., Washenik K., et al. Rediscovering thalidomide a review of its mechanism of action, side effects, and potential uses . J Am Acad Dermatol. 35:1996;969-979.
90. Fullerton P.M., O'Sullivan D.J. Thalidomide neuropathy a clinical, electrophysiological, and histological follow-up study . J Neurol Neurosurg Psychiatry. 31:1968;543-551.
91. Gardner-Medwin J.M.M., Smith N.J., Powell R.J. Clinical experience with thalidomide in the management of severe oral and genital ulceration in conditions such as Behçet's disease use of neurophys-iological studies to detect thalidomide neuropathy . Ann Rheum Dis. 53:1994;828-832.
92. Grosshans E., Illy G. Thalidomide therapy for inflammatory dermatoses. Int J Dermatol. 23:1984;598-602.
93. Burroughs M.H., Tsenova-Berkova L., Sokol K., et al. Effect of thalidomide on the inflammatory response in cerebrospinal fluid in experimental bacterial meningitis. Microb Pathog. 19:1995;245-255.
94. Tsenova L., Sokol K., Freedman V.H., Kaplan G. A combination of thalidomide plus antibiotics protects rabbits from mycobacterial meningitis-associated death. J Infect Dis. 177:1998;1563-1572.
95. Schmidt H., Rush B., Simonian G., et al. Thalidomide inhibits TNF response, and increases survival following endotoxin injection in rats. J Surg Res. 63:1996;143-146.
96. Garcia-Martínez C., Costelli P., López-Soriano F.J., Argilés J.M. Is TNF really involved in cachexia? Investigation. 15:1997;47-54.