Mifamurtide in metastatic and recurrent osteosarcoma: A patient access study with pharmacokinetic, pharmacodynamic, and safety assessments

Pediatric Blood and Cancer

Volumn 61, Issue 2, 2014, Pages 238-244

  Anderson, P M ^a,i   Meyers, P ^b   Kleinerman, E ^a   Venkatakrishnan, K ^c   Hughes, D P ^a   Herzog, C ^a   Huh, W ^a   Sutphin, R ^c   Vyas, Y M ^d   Shen, V ^e   Warwick, A ^f   Yeager, N ^g   Oliva, C ^c   Wang, B ^h   Liu, Y ^h   Chou, A ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c M D ANDERSON CANCER CENTER ORLANDO   (United States)

^d UNIVERSITY OF IOWA   (United States)

^e CHILDREN S HOSPITAL OF ORANGE COUNTY   (United States)

^f UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES   (United States)

^g OHIO STATE UNIVERSITY   (United States)

^h MILLENNIUM PHARMACEUTICALS INC   (United States)

ⁱ CAROLINAS MEDICAL CENTER   (United States)

Author keywords

Biologic therapy; L MTP PE; Macrophage activation; Mifamurtide; Osteosarcoma; Pharmacokinetics

Indexed keywords

CISPLATIN; DOCETAXEL; DOXORUBICIN; ETOPOSIDE; GEMCITABINE; IBUPROFEN; IFOSFAMIDE PLUS MESNA; INTERLEUKIN 6; METHOTREXATE; MIFAMURTIDE; PARACETAMOL; TUMOR NECROSIS FACTOR ALPHA;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; CHILD; CHILL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEADACHE; HUMAN; HYPOXIA; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MALE; MALIGNANT PLEURA EFFUSION; METASTASIS; MIDDLE AGED; NAUSEA; NEUTROPENIA; OSTEOSARCOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERICARDIAL EFFUSION; PLASMA CONCENTRATION-TIME CURVE; PLEURA EFFUSION; PRESCHOOL CHILD; PRIORITY JOURNAL; RESPIRATORY DISTRESS; RISK ASSESSMENT; SCHOOL CHILD; STEADY STATE; THROMBOCYTOPENIA; TREATMENT DURATION; VOMITING; YOUNG ADULT;

EID: 84890878456     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.24686     Document Type: Article

References (50)

1. Ferguson WS, Goorin AM. Current treatment of osteosarcoma. Cancer Invest 2001; 19:292-315.
2. Ferguson WS, Harris MB, Goorin AM, et al. Presurgical window of carboplatin and surgery and multidrug chemotherapy for the treatment of newly diagnosed metastatic or unresectable osteosarcoma: Pediatric Oncology Group Trial. J Pediatr Hematol Oncol 2001; 23:340-348.
3. Harris MB, Gieser P, Goorin AM, et al. Treatment of metastatic osteosarcoma at diagnosis: A Pediatric Oncology Group Study. J Clin Oncol 1998; 16:3641-3648.
4. Whelan JS, Jinks RC, McTiernan A, et al. Survival from high-grade localised extremity osteosarcoma: Combined results and prognostic factors from three European Osteosarcoma Intergroup randomised controlled trials. Ann Oncol 2012; 23:1607-1616.
5. Bacci G, Ferrari S, Longhi A, et al. Preoperative therapy versus immediate surgery in nonmetastatic osteosarcoma. J Clin Oncol 2003; 21:4662-4663.
6. 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; 20:776-790.
7. Jaffe N, Carrasco H, Raymond K, et al. Can cure in patients with osteosarcoma be achieved exclusively with chemotherapy and abrogation of surgery? Cancer 2002; 95:2202-2210.
8. Link MP, Goorin AM, Horowitz M, et al. Adjuvant chemotherapy of high-grade osteosarcoma of the extremity. Updated results of the Multi-Institutional Osteosarcoma Study. Clin Orthop Relat Res 1991; 270:8-14.
9. 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; 314:1600-1606.
10. Carrle D, Bielack SS. Current strategies of chemotherapy in osteosarcoma. Int Orthop 2006; 30:445-451.
11. 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; 20:426-433.
12. Mialou V, Philip T, Kalifa C, et al. Metastatic osteosarcoma at diagnosis: Prognostic factors and long-term outcome-The French pediatric experience. Cancer 2005; 104:1100-1109.
13. Crompton BD, Goldsby RE, Weinberg VK, et al. Survival after recurrence of osteosarcoma: A 20-year experience at a single institution. Pediatr Blood Cancer 2005; 46:255-259.
14. Bielack SS, Bielack SS, Kempf-Bielack B, et al. Second and subsequent recurrences of osteosarcoma: Presentation, treatment, and outcomes of 249 consecutive cooperative osteosarcoma study group patients. J Clin Oncol 2009; 27:557-565.
15. O'Day K, Gorlick R. Novel therapeutic agents for osteosarcoma. Expert Rev Anticancer Ther 2009; 9:511-523.
16. Kempf-Bielack B, Bielack SS, Jurgens H, et al. Osteosarcoma relapse after combined modality therapy: An analysis of unselected patients in the Cooperative Osteosarcoma Study Group (COSS). J Clin Oncol 2005; 23:559-568.
17. Ferrari S, Ruggieri P, Graziella C, et al. Neoadjuvant chemotherapy with methotrexate, cisplatin, and doxorubicin with or without ifosfamide in nonmetastatic osteosarcoma of the extremity: An Italian sarcoma group trial ISG/OS-1. J Clin Oncol 2012; 30:2112-2118.
18. Meazza C, Casanova M, Luksch R, et al. Prolonged 14-day continuous infusion of high-dose ifosfamide with an external portable pump: Feasibility and efficacy in refractory pediatric sarcoma. Pediatr Blood Cancer 2010; 55:617-620.
19. Huh WW, Jaffe N, Durand JB, et al. Comparison of doxorubicin cardiotoxicity in pediatric sarcoma patients when given with dexrazoxane versus as continuous infusion. Pediatr Hematol Oncol 2010; 27:546-557.
20. Janeway KA, Grier HE. Sequelae of osteosarcoma medical therapy: A review of rare acute toxicities and late effects. Lancet Oncol 2010; 11:670-678.
21. Lewis MJ, DuBois SG, Fligor B, et al. Ototoxicity in children treated for osteosarcoma. Pediatr Blood Cancer 2009; 52:387-391.
22. Longhi A, Macchiagodena M, Vitali G, et al. Fertility in male patients treated with neoadjuvant chemotherapy for osteosarcoma. J Pediatr Hematol Oncol 2003; 25:292-296.
23. Anderson P, Salazar-Abshire M. Improving outcomes in difficult bone cancers using multimodality therapy, including radiation: Physician and nursing perspectives. Curr Oncol Rep 2006; 8:415-422.
24. Anderson P, Wells P, Lazarte T, et al. Outpatient chemotherapy, family-centered care, electronic information, and education in adolescents adn young adults with osteosarcoma. Clin Oncol Adolesc Young Adults 2013; 3:1-11.
25. Smith MA, Seibel NL, Altekruse SF, et al. Outcomes for children and adolescents with cancer: Challenges for the twenty-first century. J Clin Oncol 2010; 28:2625-2634.
26. Lascelles BD, Dernell WS, Correa MT, et al. Improved survival associated with postoperative wound infection in dogs treated with limb-salvage surgery for osteosarcoma. Ann Surg Oncol 2005; 12:1073-1083.
27. Jeys LM, Grimer RJ, Carter SR, et al. Post operative infection and increased survival in osteosarcoma patients: Are they associated? Ann Surg Oncol 2007; 14:2887-2895.
28. Moore C, Eslin D, Levy A, et al. Prognostic significance of early lymphocyte recovery in pediatric osteosarcoma. Pediatr Blood Cancer 2010; 55:1096-1102.
29. Meyers PA. Muramyl tripeptide (mifamurtide) for the treatment of osteosarcoma. Expert Rev Anticancer Ther 2009; 9:1035-1049.
30. Meyers PA, Schwartz CL, Krailo MD, et al. Osteosarcoma: The addition of muramyl tripeptide to chemotherapy improves overall survival-A report from the Children's Oncology Group. J Clin Oncol 2008; 26:633-638.
31. 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; 104:2214-2221.
32. 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.
33. Kleinerman ES. Biologic therapy for osteosarcoma using liposome-encapsulated muramyl tripeptide. Hematol Oncol Clin North Am 1995; 9:927-938.
34. 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; 43:2010-2014.
35. 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; 18:93-99.
36. 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; 10:1310-1316.
37. Kleinerman ES, Meyers PA, Raymond AK, et al. Combination therapy with ifosfamide and liposome-encapsulated muramyl tripeptide: Tolerability, toxicity, and immune stimulation. J Immunother Emphasis Tumor Immunol 1995; 17:181-193.
38. 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; 49:4665-4670.
39. 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; 34:211-220.
40. Anderson PM, Tomaras M, McConnell K. Mifamurtide in osteosarcoma-A practical review. Drugs Today (Barc) 2010; 46:327-337.
41. Frampton JE. Mifamurtide: A review of its use in the treatment of osteosarcoma. Paediatr Drugs 2010; 12:141-153.
42. Huh WW, Egas-Bejar D, Anderson PM. New Treatment options for non-metastatic osteosarcoma: Focus on mifamurtide in adolescents. Clin Oncol Adolesc Young Adults 2012; 2:1-6.
43. Anderson P. Liposomal muramyl tripeptide phosphatidyl ethanolamine: Ifosfamide-containing chemotherapy in osteosarcoma. Future Oncol 2006; 2:333-343.
44. Takeda. MEPACT. Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000802/WC500026565.pdf, 2013.
45. Venkatakrishnan K, Kramer WG, Synold TW, et al. A pharmacokinetic, pharmacodynamic, and electrocardiographic study of liposomal mifamurtide (L-MTP-PE) in healthy adult volunteers. Eur J Clin Pharmacol 2012; 68:1347-1355.
46. Arndt CA, Koshkina NV, Inwards CY, et al. Inhaled granulocyte-macrophage colony stimulating factor for first pulmonary recurrence of osteosarcoma: Effects on disease-free survival and immunomodulation. a report from the Children's Oncology Group. Clin Cancer Res 2010; 16:4024-4030.
47. Mirabello L, Troisi RJ, Savage SA. Osteosarcoma incidence and survival rates from 1973 to 2004: Data from the Surveillance, Epidemiology, and End Results Program. Cancer 2009; 115:1531-1543.
48. Ando K, Mori K, Corradini N, et al. Mifamurtide for the treatment of nonmetastatic osteosarcoma. Expert Opin Pharmacother 2011; 12:285-292.
49. Asano T, Kleinerman ES. Liposome-encapsulated MTP-PE: A novel biologic agent for cancer therapy. J Immunother 1993; 14:286-292.
50. Anderson P, Aguilera D, Pearson M, et al. Outpatient chemotherapy plus radiotherapy in sarcomas: Improving cancer control with radiosensitizing agents. Cancer Control 2008; 15:38-46.