Mifamurtide: A review of its use in the treatment of osteosarcoma

Pediatric Drugs

Volumn 12, Issue 3, 2010, Pages 141-153

  Frampton, James E ^a   Anderson, P M ^b   Chou, A J ^c   Federman, N C ^d   Ferrari, S ^e   Kim, H J ^f   LoebD M , ^g   Mori, K ^h  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b UNIVERSITY OF TEXAS   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e RIZZOLI ORTHOPAEDIC INSTITUTE   (Italy)

^f HOSPITAL FOR SPECIAL SURGERY   (United States)

^g JOHNS HOPKINS UNIVERSITY   (United States)

^h SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

Author keywords

Adis Drug Evaluations; Osteosarcoma

Indexed keywords

ALPHA2B INTERFERON; ANTINEOPLASTIC AGENT; CISPLATIN; CORTICOSTEROID; CYCLOSPORIN; DIPHENHYDRAMINE; DOXORUBICIN; FOLINIC ACID; GAMMA INTERFERON; IBUPROFEN; IFOSFAMIDE; MEPACT; METHOTREXATE; MIFAMURTIDE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BACKACHE; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER FATIGUE; CANCER PAIN; CANCER RELAPSE; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL TRIAL; CONSTIPATION; COUGHING; CYTOKINE RELEASE; DIZZINESS; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG TOXICITY; DYSPNEA; HEARING LOSS; HOSPITAL PATIENT; HUMAN; HYPERTENSION; HYPOTENSION; HYPOTHERMIA; INFECTION; LIPOSOMAL DELIVERY; LIVER TOXICITY; LUNG METASTASIS; MACROPHAGE; META ANALYSIS; METASTASIS; MONOCYTE; MYALGIA; NAUSEA; NEPHROTOXICITY; OSTEOSARCOMA; OTOTOXICITY; OVERALL SURVIVAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; STOMATITIS; SYSTEMATIC REVIEW; TACHYCARDIA;

ACETYLMURAMYL-ALANYL-ISOGLUTAMINE; ANIMALS; CYTOKINES; DRUG DOSAGE CALCULATIONS; HUMANS; MACROPHAGES; MONOCYTES; OSTEOSARCOMA; PHOSPHATIDYLETHANOLAMINES;

EID: 77952570963     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.2165/11204910-000000000-00000     Document Type: Review

References (73)

1. Meyers PA, Gorlick R. Osteosarcoma. Pediatr Clin Nth Am 1997; 44: 973-989
2. Picci P. Osteosarcoma (osteogenic sarcoma). Orphanet J Rare Dis 2007; 2: 6
3. Bielack S, Carrle D, Casali PG. Osteosarcoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. AnnOncol 2009 May; 20 Suppl 4: 137-139
4. Meyers PA. Muramyl tripeptide (mifamurtide) for the treatment of osteosarcoma. Expert Rev Anticancer Ther 2009 Aug; 9 (8): 1035-1049
5. Chou AJ, Geller DS, Gorlick R. Therapy for osteosarcoma: where do we go from here? Pediatr Drugs 2008; 10 (5): 315-327
6. National Cancer Institute. Osteosarcoma and malignant fibrous histiocytoma of bone (PDQ-): osteosarcoma with metastatic disease at diagnosis [online]. Available from URL: http://www.cancer.gov/cancertopics/pdq/treatment/ osteosarcoma/HealthProfessional/page8 [Accessed 2010 Feb 12]
7. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: bone cancer. 3.2010 [online]. Available from URL: http:// www.nccn.org/professionals/physician-gls/PDF/bone.pdf [Accessed 2010 Apr 28]
8. Anderson P. Liposomal muramyl tripeptide phosphatidyl ethanolamine: ifosfamide-containing chemotherapy in osteosarcoma. Future Oncol 2006 Jun; 2 (3): 333-343
9. 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 Feb; 8 (2): 151-159
10. Anderson P, Kopp L, Anderson N, et al. Novel bone cancer drugs: investigational agents and control paradigms for primary bone sarcomas (Ewing's sarcoma and osteosarcoma). Expert Opin Investig Drugs 2008 Nov; 17 (11): 1703-1715
11. Hughes DP. Novel agents in development for pediatric sarcomas. Curr Opin Oncol 2009 Jul; 21 (4): 332-337
12. Mori K, Redini F, Gouin F, et al. Osteosarcoma: current status of immunotherapy and future trends (Review). Oncol Rep 2006 Mar; 15 (3): 693-700
13. 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 2006Mar; 6 (2): 123-133
14. 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 (2): 141-150
15. 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 Aug; 135 (2): 1372-1377
16. Lammers T, Hennink WE, Storm G. Tumour-targeted nanomedicines: principles and practice. Br J Cancer 2008; 99: 392-397
17. Huwyler J, Drewe J, Krahenbuhl S. Tumor targeting using liposomal antineoplastic drugs. Int J Nanomedicine 2008; 3 (1): 21-29
18. Fang J-Y. Nano- or submicron-sized liposomes as carriers for drug delivery. Chang Gung Med J 2006; 29: 358-362
19. Fidler IJ, Brown NO, Hart IR. Species variability for toxicity of free and liposome-encapsulated muramyl peptides administered intravenously. J Biol Response Mod 1985 Jun; 4 (3): 298-309
20. European Medicines Agency. Assessment report forMepact [online].Available from URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/mepact/ H-802-en6.pdf [Accessed 2010 Feb 11]
21. 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 May; 43: 2010-2014
22. 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 Feb; 9 (2): 259-267
23. Bucana CD, Hoyer LC, Schroit AJ, et al. Ultrastructural studies of the interaction between liposome-activated human blood monocytes and allogeneic tumor cells in vitro. Am J Pathol 1983 Jul; 112 (1): 101-111
24. 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 (6): 357-362
25. 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 Sep 30; 55 (3): 380-385
26. Galligioni E, Santarosa M, Favaro D, et al. In vitro synergic effect of interferon gamma combined with liposomes containing muramyl tripeptide on human monocyte cytoxicity against fresh allogeneic and autologous tumor cells. Tumori 1994 Oct 31; 80 (5): 385-391
27. 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: 994-998
28. 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 Oct 15; 38 (4): 495-500 (Pubitemid 16006919)
29. Murray JL, Kleinerman ES, Cunningham JE, et al. Phase I trial of liposomal muramyl tripeptide phosphatidylethanolamine in cancer patients. J Clin Oncol 1989 Dec; 7 (12): 1915-1925
30. 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 Aug 15; 49 (16): 4665-4670
31. 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 Aug; 10 (8): 1310-1316
32. Fogler WE, Fidler IJ. Nonselective destruction of murine neoplastic cells by syngeneic tumoricidal macrophages. Cancer Res 1985 Jan; 45: 14-18
33. 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 Aug; 135 (2): 1477-1483
34. 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 (2): 75-88
35. 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 (2): 118-122
36. 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 Apr; 14 (2): 121-128
37. 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 Summer; 8 (2): 137-144
38. Maeda M, Knowles RD, Kleinerman ES. Muramyl tripeptide phosphatidylethanolamine encapsulated in liposomes stimulates monocyte production of tumor necrosis factor. Cancer Commun 1991; 3 (10-11): 313-321
39. 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 Feb; 268 (2): 1032-1039
40. Asano T, Kleinerman ES. Liposome-encapsulated MTP-PE: a novel biologic agent for cancer therapy. J Immunother 1993 Nov; 14 (4): 286-292
41. Asano T, McIntyre BW, Bednarczyk JL, et al. Liposomal muramyl tripeptide upregulates adhesion molecules on the surface of human monocytes. Oncol Res 1995; 7 (5): 253-257
42. 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
43. Liebes L, Walsh CM, Chachoua A, et al. Modulation of monocyte functions by muramyl tripeptide phosphatidylethanolamine in a phase II study in patients with metastatic melanoma. J Natl Cancer Inst 1992 May 6; 84 (9): 694-699
44. Landmann R, Obrist R, Denz H, et al. Pharmacokinetics and immunomodulatory effects on monocytes during prolonged therapy with liposomal muramyltripeptide. Biotherapy 1993; 7 (1): 1-12
45. Frost H, Murray JL, Chaudri HA, et al. Interleukin-6 induction by a muramyltripeptide derivative in cancer patients. J BiolResponse Mod 1990 Apr; 9 (2): 160-166
46. Urba WJ, Hartmann LC, Longo DL, et al. Phase I and immunomodulatory study of a muramyl peptide, muramyl tripeptide phosphatidylethanolamine. Cancer Res 1990 May 15; 50 (10): 2979-2986
47. Key ME, Talmadge JE, Fogler WE, et al. Isolation of tumoricidal macrophages from lungmelanoma metastases of mice treated systematically with liposomes containing a lipophilic derivative of muramyl dipeptide. J Natl Cancer Inst 1982; 69: 1198
48. Karpoff HM, Jarnagin W, Delman K, et al. Regional muramyl tripeptide phosphatidylethanolamine administration enhances hepatic immune function and tumor surveillance. Surgery 2000; 128: 213-218
49. Thomas K, Nijenhuis AM, Dontje BH, et al. Antitumor reactivity induced by liposomal MTP-PE in a liver metastasis model of colon cancer in the rat. Clin Exp Metastasis 1995; 13: 328-336
50. 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 Jun 21; 81 (12): 935-938
51. Kurzman ID, MacEwen EG, Rosenthal RC, et al. Adjuvant therapy for osteosarcoma in dogs: results of randomized clinical trials using combined liposome-encapsulated muramyl tripeptide and cisplatin. Clin Cancer Res 1995 Dec; 1 (12): 1595-1601
52. Vail DM, MacEwen G, Kurzman ID, et al. Liposome-encapsulated muramyl tripeptide phosphatidylethanolamine adjuvant immunotherapy for splenic hemangiosarcoma in the dog. Clin Cancer Res 1995 Oct; 1: 1165-1170
53. Fidler IJ. Optimization and limitations of systemic treatment of murine melanoma metastases with liposomes containing muramyl tripeptide phosphatidylethanolamine. Cancer Immunol Immunother 1986; 21 (3): 169-173
54. Fox LE, MacEwen EG, Kurzman ID, et al. Liposome-encapsulated muramyl tripeptide phosphatidylethanolamine for the treatment of feline mammary adenocarcinoma - a multicenter randomized double-blind study. Cancer Biother 1995; 10 (2): 125-130
55. Teske E, Rutteman GR, Van Den Ingh TS, et al. Liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (L-MPT-PE): a randomized clinical trial in dogs with mammary carcinoma. Anticancer Res 1998; 18 (2A): 1015-1019
56. 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 Sep 15; 48: 5256-5263
57. 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 Apr; 17 (3): 181-193
58. 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.OncolRes 1992; 4 (10): 413-418
59. MEPACT 4mg powder for suspension for infusion: summary of product characteristics. Paris: IDM, 2010
60. 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 (1): 45-51
61. 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 Apr; 18 (2): 93-99
62. 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 Feb 1; 26 (4): 633-638 Plus supplementary material available from URL: http://jco.ascopubs.org [Accessed 2010 Apr 27]
63. 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 Mar 20; 23 (9): 2004-2011
64. Chou AJ,Kleinerman ES,Krailo MD, et al. Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group. Cancer 2009; 115: 5339-5348
65. 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 Mod 1990 Oct; 9 (5): 492-498
66. European and American Osteosarcoma Study Group. Combination chemotherapy, PEG-interferon alfa-2b, and surgery in treating patients with osteosarcoma [online]. Available from URL: http://clinicaltrials.gov/ct2/show/ NCT00134030 [Accessed 2010 Mar 4]
67. Bielack SS, Marina N, Ferrari S, et al. Osteosarcoma: the same old drugs or more? [letter]. J Clin Oncol 2008 Jun 20; 26 (18): 3102-3, author reply 3104-3105
68. Meyers PA, Schwartz CL, Krailo MD, et al. In reply [letter]. J Clin Oncol 2008; 26 (18): 3104-3105
69. Platinol AQ (cisplatin injection). US prescribing information. Princeton (NJ): Bristol-Myers Squibb Company, 1999 Oct
70. Hunsberger S, Freidlin B, Smith MA. Complexities in interpretation of osteosarcoma clinical trial results [letter]. J Clin Oncol 2008; 26 (18): 3103-3104
71. Oncologic Drugs Advisory Committee. FDA briefing document: NDA 022092 mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) INT 0133 Cooperative Group protocol [online]. Available from URL: http:// www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b1-02-FDA-redacted. pdf [Accessed 2010 Apr 28]
72. IDM Pharma's MEPACT (mifamurtide, L-MTP-PE) receives approval in Europe for treatment of patients with resectable osteosarcoma [online]. Available from URL: http://www.prnewswire.co.uk/cgi/news/release?id= 251191 [Accessed 2010 Mar 9]
73. L-MTP-PE for high-risk osteosarcoma [ClinicalTrials.gov identifier NCT00631631]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2010 May 6]