Mifamurtide for the treatment of nonmetastatic osteosarcoma

Expert Opinion on Pharmacotherapy

Volumn 12, Issue 2, 2011, Pages 285-292

  Ando, Kosei ^a   Mori, Kanji ^a   Corradini, Nedge ^b,c,d   Redini, Françoise ^b,c   Heymann, Dominique ^b,c,d  

^a SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^b INSERM   (France)

^c UNIVERSITÉ DE NANTES   (France)

^d NANTES UNIVERSITY HOSPITAL   (France)

Author keywords

Chemotherapy; Innate immunity; Liposomal muramyl tripeptide phosphatidylethanolamine; Macrophage; Osteosarcoma

Indexed keywords

CISPLATIN; DOXORUBICIN; IBUPROFEN; IFOSFAMIDE; METHOTREXATE; MIFAMURTIDE; PARACETAMOL;

ADVANCED CANCER; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RELAPSE; CHEMICAL STRUCTURE; CHILL; CONSTIPATION; DRUG MEGADOSE; DRUG TOLERABILITY; DYSPNEA; EUROPE; FEVER; HUMAN; HYPOTENSION; HYPOTHERMIA; IN VITRO STUDY; IN VIVO STUDY; NAUSEA; OSTEOSARCOMA; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROSPECTIVE STUDY; TACHYCARDIA; TREATMENT DURATION; VOMITING;

ACETYLMURAMYL-ALANYL-ISOGLUTAMINE; ADJUVANTS, IMMUNOLOGIC; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; DISEASE PROGRESSION; HUMANS; NEOADJUVANT THERAPY; OSTEOSARCOMA; PHOSPHATIDYLETHANOLAMINES;

EID: 78651452000     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.2011.543129     Document Type: Article

References (72)

1. Meyers PA, Gorlick R. Osteosarcoma. Pediatr Clin North Am 1997;44:973-89 (Pubitemid 27368674)
2. Picci P. Osteosarcoma (osteogenic sarcoma). Orphanet J Rare Dis 2007;2:6. doi: 10.1186/1750-1172-2-6
3. Stiller CA, Bielack SS, Jundt G, et al. Bone tumours in European children and adolescents, 1978-1997. Report from the Automated Childhood Cancer Information System project. Eur J Cancer 2006;42:2124-35 (Pubitemid 44240494)
4. Bielack SS, Kempf-Bielack B, Delling G, et al. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol 2002;20:776-90 (Pubitemid 34111386)
5. Link MP, Goorin AM, Miser AW, et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med 1986;314:1600-6
6. Meyers PA, Heller G, Healey J, et al. Chemotherapy for nonmetastatic osteogenic sarcoma: the Memorial Sloan-Kettering experience. J Clin Oncol 1992;10:5-15
7. Harris MB, Cantor AB, Goorin AM, et al. Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study. Med Pediatr Oncol 1995;24:87-92
8. Kung FH, Pratt CB, Vega RA, et al. Ifosfamide/etoposide combination in the treatment of recurrent malignant solid tumors of childhood. A Pediatric Oncology Group Phase II study. Cancer 1993;71:1898-903
9. Miser JS, Kinsella TJ, Triche TJ, et al. Ifosfamide with mesna uroprotection and etoposide: an effective regimen in the treatment of recurrent sarcomas and other tumors of children and young adults. J Clin Oncol 1987;5:1191-8
10. de Kraker J, Voute PA. Experience with ifosfamide in paediatric tumours. Cancer Chemother Pharmacol 1989;24(Suppl 1):S28-9 (Pubitemid 19197359)
11. Bacci G, Ferrari S, Longhi A, et al. High dose ifosfamide in combination with high dose methotrexate, adriamycin and cisplatin in the neoadjuvant treatment of extremity osteosarcoma: preliminary results of an Italian Sarcoma Group/Scandinavian Sarcoma Group pilot study. J Chemother 2002;14:198-206 (Pubitemid 34460560)
12. Meyers PA, Schwartz CL, Krailo M, et al. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol 2005;23:2004-11 (Pubitemid 46211380)
13. Anderson P. Liposomal muramyl tripeptide phosphatidyl ethanolamine: ifosfamide-containing chemotherapy in osteosarcoma. Future Oncol 2006;2:333-43 (Pubitemid 43960105)
14. Hawkins DS, Arndt CA. Pattern of disease recurrence and prognostic factors in patients with osteosarcoma treated with contemporary chemotherapy. Cancer 2003;98:2447-56
15. Bacci G, Lari S. Adjuvant and neoadjuvant chemotherapy in osteosarcoma. Chir Organi Mov 2001;86:253-68
16. Meyers PA. Muramyl tripeptide (mifamurtide) for the treatment of osteosarcoma. Expert Rev Anticancer Ther 2009;9:1035-49
17. Meyers PA, Schwartz CL, Krailo MD, et al. Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival - a report from the Childrens Oncology Group. J Clin Oncol 2008;26:633-8
18. Mori K, Ando K, Heymann D. Liposomal muramyl tripeptide phosphatidyl ethanolamine: a safe and effective agent against osteosarcoma pulmonary metastases. Expert Rev Anticancer Ther 2008;8:151-9 (Pubitemid 351385905)
19. Anderson P, Kopp L, Anderson N, et al. Novel bone cancer drugs: investigational agents and control paradigms for primary bone sarcomas (Ewings sarcoma and osteosarcoma). Expert Opin Investig Drugs 2008;17:1703-15
20. Hughes DP. Novel agents in development for pediatric sarcomas. Curr Opin Oncol 2009;21:332-7
21. Nardin A, Lefebvre ML, Labroquere K, et al. Liposomal muramyl tripeptide phosphatidylethanolamine: targeting and activating macrophages for adjuvant treatment of osteosarcoma. Curr Cancer Drug Targets 2006;6:123-33
22. Fogler WE, Fidler IJ. Comparative interaction of free and liposome-encapsulated nor-muramyl dipeptide or muramyl tripeptide phosphatidylethanolamine (3H-labelled) with human blood monocytes. Int J Immunopharmacol 1987;9:141-50
23. Schroit AJ, Fidler IJ. Delivery of macrophage-augmenting factors encapsulated in liposomes for destruction of tumor metastases. Prog Clin Biol Res 1982;102:347-55
24. Kleinerman ES, Erickson KL, Schroit AJ, et al. Activation of tumoricidal properties in human blood monocytes by liposomes containing lipophilic muramyl tripeptide. Cancer Res 1983;43:2010-14
25. Fogler WE, Fidler IJ. Nonselective destruction of murine neoplastic cells by syngeneic tumoricidal macrophages. Cancer Res 1985;45:14-8
26. Galligioni E, Quaia M, Spada A, et al. Activation of cytolytic activity in peripheral blood monocytes of renal cancer patients against non-cultured autologous tumor cells. Int J Cancer 1993;55:380-5 (Pubitemid 23300583)
27. Asano T, McWatters A, An T, et al. Liposomal muramyl tripeptide up-regulates interleukin-1 alpha, interleukin-1 beta, tumor necrosis factor-alpha, interleukin-6 and interleukin-8 gene expression in human monocytes. J Pharmacol Exp Ther 1994;268:1032-9 (Pubitemid 24085911)
28. Kurzman ID, Shi F, Vail DM, et al. In vitro and in vivo enhancement of canine pulmonary alveolar macrophage cytotoxic activity against canine osteosarcoma cells. Cancer Biother Radiopharm 1999;14:121-8 (Pubitemid 29217791)
29. Dieter P, Ambs P, Fitzke E, et al. Comparative studies of cytotoxicity and the release of TNF-alpha, nitric oxide, and eicosanoids of liver macrophages treated with lipopolysaccharide and liposome-encapsulated MTP-PE. J Immunol 1995;155:2595-604
30. MacEwen EG, Kurzman ID, Vail DM, et al. Adjuvant therapy for melanoma in dogs: results of randomized clinical trials using surgery, liposome-encapsulated muramyl tripeptide, and granulocyte macrophage colony-stimulating factor. Clin Cancer Res 1999;5:4249-58
31. Asano T, McIntyre BW, Bednarczyk JL, et al. Liposomal muramyl tripeptide upregulates adhesion molecules on the surface of human monocytes. Oncol Res 1995;7:253-7
32. Fogler WE, Wade R, Brundish DE, et al. Distribution and fate of free and liposome-encapsulated [3H]nor-muramyl dipeptide and [3H]muramyl tripeptide phosphatidylethanolamine in mice. J Immunol 1985;135:1372-7 (Pubitemid 16237463)
33. Cryan SA. Carrier-based strategies for targeting protein and peptide drugs to the lungs. AAPS J 2005;7:E20-41 (Pubitemid 41554302)
34. Zamboni WC. Liposomal, nanoparticle, and conjugated formulations of anticancer agents. Clin Cancer Res 2005;11:8230-4
35. Gay B, Cardot JM, Schnell C, et al. Comparative pharmacokinetics of free muramyl tripeptide phosphatidyl ethanolamine (MTP-PE) and liposomal MTP-PE. J Pharm Sci 1993;82:997-1001 (Pubitemid 23314102)
36. Murray JL, Kleinerman ES, Cunningham JE, et al. Phase I trial of liposomal muramyl tripeptide phosphatidylethanolamine in cancer patients. J Clin Oncol 1989;7:1915-25 (Pubitemid 20014341)
37. Dieter P, Hempel U, Kamionka S, et al. Prostaglandin E2 affects differently the release of inflammatory mediators from resident macrophages by LPS and muramyl tripeptides. Mediators Inflamm 1999;8:295-303 (Pubitemid 30232875)
38. MacEwen EG, Kurzman ID, Rosenthal RC, et al. Therapy for osteosarcoma in dogs with intravenous injection of liposome-encapsulated muramyl tripeptide. J Natl Cancer Inst 1989;81:935-8
39. Kleinerman ES, Snyder JS, Jaffe N. Influence of chemotherapy administration on monocyte activation by liposomal muramyl tripeptide phosphatidylethanolamine in children with osteosarcoma. J Clin Oncol 1991;9:259-67
40. Europeans Medicines Agency. Assessment report for Mepact. Available from: http://www.ema.europa.eu/humandocs/ PDFs/EPAR/mepact/H-802-en6.pdf [Last accessed 25 September 2010]
41. Strober W, Murray PJ, Kitani A, et al. Signalling pathways and molecular interactions of NOD1 and NOD2. Nat Rev Immunol 2006;6:9-20 (Pubitemid 43279749)
42. Fidler IJ, Brown NO, Hart IR. Species variability for toxicity of free and liposome-encapsulated muramyl peptides administered intravenously. J Biol Response Modif 1985;4:298-309
43. Fidler IJ, Jessup JM, Fogler WE, et al. Activation of tumoricidal properties in peripheral blood monocytes of patients with colorectal carcinoma. Cancer Res 1986;46:994-8 (Pubitemid 16145470)
44. Sone S, Utsugi T, Tandon P, et al. Tumor cytotoxicity and interleukin 1 production of blood monocytes of lung cancer patients. Cancer Immunol Immunother 1990;30:357-62 (Pubitemid 20042152)
45. Dinney CP, Tanguay S, Bucana CD, et al. Intravesical liposomal muramyl tripeptide phosphatidylethanolamine treatment of human bladder carcinoma growing in nude mice. J Interferon Cytokine Res 1995;15:585-92
46. Fidler IJ, Fan D, Ichinose Y. Potent in situ activation of murine lung macrophages and therapy of melanoma metastases by systemic administration of liposomes containing muramyltripeptide phosphatidylethanolamine and interferon gamma. Invasion Metastasis 1989;9:75-88 (Pubitemid 19075670)
47. Goldbach P, Dumont S, Kessler R, et al. In situ activation of mouse alveolar macrophages by aerosolized liposomal IFN-gamma and muramyl tripeptide. Am J Physiol 1996;270:L429-34
48. Utsugi T, Nii A, Fan D, et al. Comparative efficacy of liposomes containing synthetic bacterial cell wall analogues for tumoricidal activation of monocytes and macrophages. Cancer Immunol Immunother 1991;33:285-92
49. Galligioni E, Santarosa M, Favaro D, et al. In vitro synergic effect of interferon gamma combined with liposomes containing muramyl tripeptide on human monocyte cytotoxicity against fresh allogeneic and autologous tumor cells. Tumori 1994;80:385-91
50. Sone S, Tandon P, Utsugi T, et al. Synergism of recombinant human interferon gamma with liposome-encapsulated muramyl tripeptide in activation of the tumoricidal properties of human monocytes. Int J Cancer 1986;38:495-500 (Pubitemid 16006919)
51. Kleinerman ES, Murray JL, Snyder JS, et al. Activation of tumoricidal properties in monocytes from cancer patients following intravenous administration of liposomes containing muramyl tripeptide phosphatidylethanolamine. Cancer Res 1989;49:4665-70
52. Kleinerman ES, Jia SF, Griffin J, et al. Phase II study of liposomal muramyl tripeptide in osteosarcoma: the cytokine cascade and monocyte activation following administration. J Clin Oncol 1992;10:1310-16
53. Talmadge JE, Schneider M, Collins M, et al. Augmentation of NK cell activity in tissue specific sites by liposomes incorporating MTP-PE. J Immunol 1985;135:1477-83 (Pubitemid 16237063)
54. Xu Z, Fidler IJ. The in situ activation of cytotoxic properties in murine Kupffer cells by the systemic administration of whole Mycobacterium bovis organisms or muramyl tripeptide. Cancer Immunol Immunother 1984;18:118-22 (Pubitemid 15213365)
55. Smith BW, Kurzman ID, Schultz KT, et al. Muramyl peptides augment the in vitro and in vivo cytostatic activity of canine plastic-adherent mononuclear cells against canine osteosarcoma cells. Cancer Biother 1993;8:137-44
56. Bielack S, Kempf-Bielack B, Schwenzer D, et al. Neoadjuvant therapy for localized osteosarcoma of extremities. Results from the Cooperative osteosarcoma study group COSS of 925 patients. Klin Padiatr 1999;211:260-70 (Pubitemid 29364766)
57. Hudson MM, Snyder JS, Jaffe N, et al. In vitro and in vivo effect of adriamycin therapy on monocyte activation by liposome-encapsulated immunomodulators. Cancer Res 1988;48:5256-63
58. Kleinerman ES, Meyers PA, Raymond AK, et al. Combination therapy with ifosfamide and liposome-encapsulated muramyl tripeptide: tolerability, toxicity, and immune stimulation. J Immunother 1995;17:181-93
59. Killion JJ, Kleinerman ES, Wilson MR, et al. Sequential therapy with chemotherapeutic drugs and liposome-encapsulated muramyl tripeptide: determination of potential interactions between these agents. Oncol Res 1992;4:413-18
60. MEPACT 4 mg powder dor suspension for infusion: summary of product characteristics. Paris: IDM. In, 2010
61. Provisor AJ, Ettinger LJ, Nachman JB, et al. Treatment of nonmetastatic osteosarcoma of the extremity with preoperative and postoperative chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol 1997;15:76-84
62. Hunsberger S, Freidlin B, Smith MA. Complexities in interpretation of osteosarcoma clinical trial results. J Clin Oncol 2008;26:3103-4; author reply 4-5
63. Bielack SS, Marina N, Ferrari S, et al. Osteosarcoma: the same old drugs or more? J Clin Oncol 2008;26:3102-3; author reply 4-5
64. Goorin AM, Harris MB, Bernstein M, et al. Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial. J Clin Oncol 2002;20:426-33 (Pubitemid 34072525)
65. Chou AJ, Merola PR, Wexler LH, et al. Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience. Cancer 2005;104:2214-21
66. Lafleur EA, Koshkina NV, Stewart J, et al. Increased Fas expression reduces the metastatic potential of human osteosarcoma cells. Clin Cancer Res 2004;10:8114-19 (Pubitemid 39587553)
67. Urba WJ, Hartmann LC, Longo DL, et al. Phase I and immunomodulatory study of a muramyl peptide, muramyl tripeptide phosphatidylethanolamine. Cancer Res 1990;50:2979-86
68. Creaven PJ, Cowens JW, Brenner DE, et al. Initial clinical trial of the macrophage activator muramyl tripeptide-phosphatidylethanolamine encapsulated in liposomes in patients with advanced cancer. J Biol Response Modif 1990;9:492-8
69. Kleinerman ES, Gano JB, Johnston DA, et al. Efficacy of liposomal muramyl tripeptide (CGP 19835A) in the treatment of relapsed osteosarcoma. Am J Clin Oncol 1995;18:93-9
70. Fujimaki W, Griffin JR, Kleinerman ES. Effect of ibuprofen on monocyte activation by liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (CGP 19835A): can ibuprofen reduce fever and chills without compromising immune stimulation? Cancer Immunol Immunother 1993;36:45-51
71. Fedorocko P, Hoferova Z, Hofer M, et al. Administration of liposomal muramyl tripeptide phosphatidylethanolamine (MTP-PE) and diclofenac in the combination attenuates their anti-tumor activities. Neoplasma 2003;50:176-84 (Pubitemid 36830088)
72. Kleinerman ES, Raymond AK, Bucana CD, et al. Unique histological changes in lung metastases of osteosarcoma patients following therapy with liposomal muramyl tripeptide (CGP 19835A lipid). Cancer Immunol Immunother 1992;34:211-20