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Mitoxantrone 

Mitoxantrone hydrochloride  is the hydrochloride salt of an anthracenedione antibiotic with antineoplastic activity. Mitoxantrone intercalates into and crosslinks DNA, thereby disrupting DNA and RNA replication. This agent also binds to topoisomerase II, resulting in DNA strand breaks and inhibition of DNA repair. Mitoxantrone is less cardiotoxic compared to doxorubicin. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus).

NOVANTRONE® (mitoxantrone hydrochloride) is a synthetic antineoplastic anthracenedione for intravenous use. The molecular formula is C₂₂H₂₈N₄O₆•2HCl and the molecular weight is 517.41. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with sodium chloride (0.80% w/v), sodium acetate (0.005% w/v), and acetic acid (0.046% w/v) as inactive ingredients. The solution has a pH of 3.0 to 4.5 and contains 0.14 mEq of sodium per mL. The product does not contain preservatives.

Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity. NOVANTRONE® has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen pre sentation, as well as the secretion of interferon gamma, TNFα, and IL-2.

Mitoxantrone is used in the treatment of certain types of cancer, mostly metastatic breast cancer, acute myeloid leukemia, and non-Hodgkin's lymphoma. The combination of mitoxantrone and prednisone is approved as a second-line treatment for metastatic hormone-refractory prostate cancer. This combination has been the first line of treatment, until recently, when combination of docetaxel and prednisone has been shown to improve survival and disease-free period. Mitoxantrone is also used to treat multiple sclerosis (MS), most notably the subset known as secondary progressive MS. Mitoxantrone will not cure multiple sclerosis, but is effective in slowing the progression of secondary progressive MS and extending the time between relapses in relapsing-remitting MS and progressive relapsing MS.

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2: Marriott JJ, Miyasaki JM, Gronseth G, O'Connor PW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Evidence Report: The efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010 May 4;74(18):1463-70. Review. PubMed PMID: 20439849; PubMed Central PMCID: PMC2871006.

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13: Faderl S, Wierda W, O'Brien S, Ferrajoli A, Lerner S, Keating MJ. Fludarabine, cyclophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL <70 Years. Leuk Res. 2010 Mar;34(3):284-8. Epub 2009 Jul 30. PubMed PMID: 19646755.

14: Lamanna N, Kay NE. Pentostatin treatment combinations in chronic lymphocytic leukemia. Clin Adv Hematol Oncol. 2009 Jun;7(6):386-92. Review. PubMed PMID: 19606074.

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16: Zhang Y, Byun Y, Ren YR, Liu JO, Laterra J, Pomper MG. Identification of inhibitors of ABCG2 by a bioluminescence imaging-based high-throughput assay. Cancer Res. 2009 Jul 15;69(14):5867-75. Epub 2009 Jun 30. PubMed PMID: 19567678; PubMed Central PMCID: PMC2711991.

17: Bosanquet AG, Richards SM, Wade R, Else M, Matutes E, Dyer MJ, Rassam SM, Durant J, Scadding SM, Raper SL, Dearden CE, Catovsky D. Drug cross-resistance and therapy-induced resistance in chronic lymphocytic leukaemia by an enhanced method of individualised tumour response testing. Br J Haematol. 2009 Aug;146(4):384-95. Epub 2009 Jun 22. PubMed PMID: 19552723.

18: Krupitskaya Y, Wakelee HA. Ramucirumab, a fully human mAb to the transmembrane signaling tyrosine kinase VEGFR-2 for the potential treatment of cancer. Curr Opin Investig Drugs. 2009 Jun;10(6):597-605. PubMed PMID: 19513949.

19: Hauswald S, Duque-Afonso J, Wagner MM, Schertl FM, Lübbert M, Peschel C, Keller U, Licht T. Histone deacetylase inhibitors induce a very broad, pleiotropic anticancer drug resistance phenotype in acute myeloid leukemia cells by modulation of multiple ABC transporter genes. Clin Cancer Res. 2009 Jun 1;15(11):3705-15. Epub 2009 May 19. PubMed PMID: 19458058.

20: Tiwari AK, Sodani K, Wang SR, Kuang YH, Ashby CR Jr, Chen X, Chen ZS. Nilotinib (AMN107, Tasigna) reverses multidrug resistance by inhibiting the activity of the ABCB1/Pgp and ABCG2/BCRP/MXR transporters. Biochem Pharmacol. 2009 Jul 15;78(2):153-61. Epub 2009 Apr 11. PubMed PMID: 19427995.

21: Hussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ, Donnelly BJ, Sundram SK, Burch PA, Dipaola RS, Crawford ED. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009 May 20;27(15):2450-6. Epub 2009 Apr 20. PubMed PMID: 19380444; PubMed Central PMCID: PMC2684851.

22: Rosenberg JE, Ryan CJ, Weinberg VK, Smith DC, Hussain M, Beer TM, Ryan CW, Mathew P, Pagliaro LC, Harzstark AL, Sharib J, Small EJ. Phase I study of ixabepilone, mitoxantrone, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy: a study of the department of defense prostate cancer clinical trials consortium. J Clin Oncol. 2009 Jun 10;27(17):2772-8. Epub 2009 Apr 6. PubMed PMID: 19349545; PubMed Central PMCID: PMC2698016.

23: McGregor BA, Brown AW, Osswald MB, Savona MR. The use of higher dose clofarabine in adults with relapsed acute lymphoblastic leukemia. Am J Hematol. 2009 Apr;84(4):228-30. Review. PubMed PMID: 19260120.

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25: Volpe A, Racioppi M, Sacco E, Bongiovanni L, D'Agostino D, Cappa E, Pinto F, Gardi M, Totaro A, Bassi P. New therapeutical approaches for non muscle invasive bladder cancer. Arch Ital Urol Androl. 2008 Dec;80(4):136-42. Review. PubMed PMID: 19235429.

26: Metzeler KH, Boeck S, Christ B, Hausmann A, Stemmler HJ, Parhofer KG, Ostermann H, Hiddemann W, Braess J. Idiopathic hyperammonemia (IHA) after dose-dense induction chemotherapy for acute myeloid leukemia: Case report and review of the literature. Leuk Res. 2009 Jul;33(7):e69-72. Epub 2009 Feb 23. Review. PubMed PMID: 19230970.

27: Knauf W. Bendamustine in the treatment of chronic lymphocytic leukemia. Expert Rev Anticancer Ther. 2009 Feb;9(2):165-74. Review. PubMed PMID: 19192955.

28: Moinpour CM, Donaldson GW, Nakamura Y. Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial. Qual Life Res. 2009 Mar;18(2):147-55. Epub 2009 Jan 9. PubMed PMID: 19130298; PubMed Central PMCID: PMC2859212.

29: Zhang Y, Laterra J, Pomper MG. Hedgehog pathway inhibitor HhAntag691 is a potent inhibitor of ABCG2/BCRP and ABCB1/Pgp. Neoplasia. 2009 Jan;11(1):96-101. PubMed PMID: 19107236; PubMed Central PMCID: PMC2606123.

30: Shi Z, Tiwari AK, Shukla S, Robey RW, Kim IW, Parmar S, Bates SE, Si QS, Goldblatt CS, Abraham I, Fu LW, Ambudkar SV, Chen ZS. Inhibiting the function of ABCB1 and ABCG2 by the EGFR tyrosine kinase inhibitor AG1478. Biochem Pharmacol. 2009 Mar 1;77(5):781-93. Epub 2008 Nov 18. PubMed PMID: 19059384; PubMed Central PMCID: PMC2843910.

31: Büchner T, Berdel WE, Haferlach C, Haferlach T, Schnittger S, Müller-Tidow C, Braess J, Spiekermann K, Kienast J, Staib P, Grüneisen A, Kern W, Reichle A, Maschmeyer G, Aul C, Lengfelder E, Sauerland MC, Heinecke A, Wörmann B, Hiddemann W. Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: a study by the German Acute Myeloid Leukemia Cooperative Group. J Clin Oncol. 2009 Jan 1;27(1):61-9. Epub 2008 Dec 1. PubMed PMID: 19047294.

32: Beardsley EK, Chi KN. Systemic therapy after first-line docetaxel in metastatic castration-resistant prostate cancer. Curr Opin Support Palliat Care. 2008 Sep;2(3):161-6. Review. PubMed PMID: 18685415.

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34: Armstrong AJ, Halabi S, de Wit R, Tannock IF, Eisenberger M. The relationship of body mass index and serum testosterone with disease outcomes in men with castration-resistant metastatic prostate cancer. Prostate Cancer Prostatic Dis. 2009;12(1):88-93. Epub 2008 Jun 24. PubMed PMID: 18574490.

35: Azim HA Jr, Mok T. Systemic nonhormonal management of advanced prostate cancer and its likely impact on patients' survival and quality of life. Anticancer Drugs. 2008 Jul;19(6):645-53. Review. PubMed PMID: 18525325.

36: Errante D, Bianco A, Aversa SM, Salvagno L; Non-Hodgkin's Lymphoma Cooperative Study Group. Comment on: 'Non-Hodgkin's lymphoma in very elderly patients over 80 years. A descriptive analysis of clinical presentation and outcome'. Ann Oncol. 2008 Jul;19(7):1359-60. Epub 2008 May 21. PubMed PMID: 18499645.

37: Lutterotti A, Martin R. Getting specific: monoclonal antibodies in multiple sclerosis. Lancet Neurol. 2008 Jun;7(6):538-47. Review. PubMed PMID: 18485317.

38: Kell J. Treatment of relapsed acute myeloid leukaemia. Rev Recent Clin Trials. 2006 May;1(2):103-11. Review. PubMed PMID: 18473961.

39: Armstrong AJ, Garrett-Mayer EL, Eisenberger M. Re: Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2008 May 7;100(9):681-2; author reply 682-3. Epub 2008 Apr 29. PubMed PMID: 18445824.

40: Flaig TW, Tangen CM, Hussain MH, Stadler WM, Raghavan D, Crawford ED, Glodé LM; Southwest Oncology Group. Randomization reveals unexpected acute leukemias in Southwest Oncology Group prostate cancer trial. J Clin Oncol. 2008 Mar 20;26(9):1532-6. PubMed PMID: 18349405.

41: Garmey EG, Sartor O, Halabi S, Vogelzang NJ. Second-line chemotherapy for advanced hormone-refractory prostate cancer. Clin Adv Hematol Oncol. 2008 Feb;6(2):118-22, 127-32. Review. PubMed PMID: 18347563.

42: Kuzhan O, Ozet A, Ulutin C, Kömürcü S, Arpaci F, Oztürk B, Oztürk M. Survival benefit with GM-CSF use after high-dose chemotherapy in high-risk breast cancer. Tumori. 2007 Nov-Dec;93(6):550-6. PubMed PMID: 18338488.

43: Sowery RD, Hadaschik BA, So AI, Zoubeidi A, Fazli L, Hurtado-Coll A, Gleave ME. Clusterin knockdown using the antisense oligonucleotide OGX-011 re-sensitizes docetaxel-refractory prostate cancer PC-3 cells to chemotherapy. BJU Int. 2008 Aug;102(3):389-97. Epub 2008 Mar 11. PubMed PMID: 18336596.

44: Magnus B, Tomas A, Anders A, Eva O. CNOP (mitoxantrone) chemotherapy is inferior to CHOP (doxorubicin) in the treatment of patients with aggressive non-Hodgkin lymphoma (meta-analysis). Eur J Haematol. 2008 Jun;80(6):477-82. Epub 2008 Mar 10. PubMed PMID: 18331601.

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46: Takagi K, Dexheimer TS, Redon C, Sordet O, Agama K, Lavielle G, Pierré A, Bates SE, Pommier Y. Novel E-ring camptothecin keto analogues (S38809 and S39625) are stable, potent, and selective topoisomerase I inhibitors without being substrates of drug efflux transporters. Mol Cancer Ther. 2007 Dec;6(12 Pt 1):3229-38. PubMed PMID: 18089716.

47: Crump M, Gluck S, Tu D, Stewart D, Levine M, Kirkbride P, Dancey J, O'Reilly S, Shore T, Couban S, Girouard C, Marlin S, Shepherd L, Pritchard KI. Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16. J Clin Oncol. 2008 Jan 1;26(1):37-43. Epub 2007 Nov 19. PubMed PMID: 18025439.

48: Mihelic R, Kaufman J, Lonial S, Flowers C. Maintenance therapy in lymphoma. Clin Lymphoma Myeloma. 2007 Sep;7(8):507-13. Review. PubMed PMID: 18021467.

49: Fina M, Tani M, Stefoni V, Musuraca G, Marchi E, Pellegrini C, Alinari L, Derenzini E, Bacci F, Pileri S, Baccarani M, Zinzani PL. VNCOP-B plus rituximab in the treatment of diffuse large B-cell lymphoma in the elderly. Leuk Lymphoma. 2007 Nov;48(11):2167-71. PubMed PMID: 17990178.

50: Liao Z, Robey RW, Guirouilh-Barbat J, To KK, Polgar O, Bates SE, Pommier Y. Reduced expression of DNA topoisomerase I in SF295 human glioblastoma cells selected for resistance to homocamptothecin and diflomotecan. Mol Pharmacol. 2008 Feb;73(2):490-7. Epub 2007 Nov 5. PubMed PMID: 17984197.

51: Adès L, Sanz MA, Chevret S, Montesinos P, Chevallier P, Raffoux E, Vellenga E, Guerci A, Pigneux A, Huguet F, Rayon C, Stoppa AM, de la Serna J, Cahn JY, Meyer-Monard S, Pabst T, Thomas X, de Botton S, Parody R, Bergua J, Lamy T, Vekhoff A, Negri S, Ifrah N, Dombret H, Ferrant A, Bron D, Degos L, Fenaux P. Treatment of newly diagnosed acute promyelocytic leukemia (APL): a comparison of French-Belgian-Swiss and PETHEMA results. Blood. 2008 Feb 1;111(3):1078-84. Epub 2007 Nov 1. PubMed PMID: 17975017.

52: Chowdhury S, Burbridge S, Harper PG. Chemotherapy for the treatment of hormone-refractory prostate cancer. Int J Clin Pract. 2007 Dec;61(12):2064-70. Epub 2007 Oct 23. Review. PubMed PMID: 17956560.

53: Moinpour CM, Donaldson GW, Redman MW. Do general dimensions of quality of life add clinical value to symptom data? J Natl Cancer Inst Monogr. 2007;(37):31-8. PubMed PMID: 17951229.

54: Morrison VA. Non-Hodgkin's lymphoma in the elderly. Part 2: treatment of diffuse aggressive lymphomas. Oncology (Williston Park). 2007 Sep;21(10):1191-8; discussion 1198-1208, 1210. Review. PubMed PMID: 17926798.

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56: Tan W. [Promising new treatment options for metastatic androgen-independent prostate cancer]. Actas Urol Esp. 2007 Jun;31(6):680-5. Review. Spanish. PubMed PMID: 17896565.

57: Gravis G, Salem N, Bladou F, Viens P. [Prostate cancer and chemotherapy]. Bull Cancer. 2007 Jul;94(7 Suppl):F21-8. Review. French. PubMed PMID: 17845990.

58: Oudard S, Banu E, Scotte F, Banu A, Medioni J, Beuzeboc P, Joly F, Ferrero JM, Goldwasser F, Andrieu JM. Prostate-specific antigen doubling time before onset of chemotherapy as a predictor of survival for hormone-refractory prostate cancer patients. Ann Oncol. 2007 Nov;18(11):1828-33. Epub 2007 Sep 9. PubMed PMID: 17846024.

59: Hadaschik BA, Gleave ME. Therapeutic options for hormone-refractory prostate cancer in 2007. Urol Oncol. 2007 Sep-Oct;25(5):413-9. Review. PubMed PMID: 17826663.

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62: Tobinai K, Takeyama K, Arima F, Aikawa K, Kobayashi T, Hanada S, Kasai M, Ogura M, Sueoka E, Mukai K, Tajima K, Fukuda H, Shirakawa S, Hotta T, Masanori S; Lymphoma Study Group of the Japan Clinical Oncology Group. Phase II study of chemotherapy and stem cell transplantation for adult acute lymphoblastic leukemia or lymphoblastic lymphoma: Japan Clinical Oncology Group Study 9004. Cancer Sci. 2007 Sep;98(9):1350-7. Epub 2007 Jul 19. PubMed PMID: 17640299.

63: Limtrakul P. Curcumin as chemosensitizer. Adv Exp Med Biol. 2007;595:269-300. Review. PubMed PMID: 17569216.

64: Petrylak DP. New paradigms for advanced prostate cancer. Rev Urol. 2007;9 Suppl 2:S3-S12. PubMed PMID: 17554403; PubMed Central PMCID: PMC1887815.

65: Lim SJ, Cormier JN, Feig BW, Mansfield PF, Benjamin RS, Griffin JR, Chase JL, Pisters PW, Pollock RE, Hunt KK. Toxicity and outcomes associated with surgical cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with sarcomatosis. Ann Surg Oncol. 2007 Aug;14(8):2309-18. Epub 2007 May 31. PubMed PMID: 17541691.

66: Maurillo L, Buccisano F, Spagnoli A, Del Poeta G, Panetta P, Neri B, Del Principe MI, Mazzone C, Consalvo MI, Tamburini A, Ottaviani L, Fraboni D, Sarlo C, De Fabritiis P, Amadori S, Venditti A. Monitoring of minimal residual disease in adult acute myeloid leukemia using peripheral blood as an alternative source to bone marrow. Haematologica. 2007 May;92(5):605-11. PubMed PMID: 17488683.

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68: Robey RW, Polgar O, Deeken J, To KW, Bates SE. ABCG2: determining its relevance in clinical drug resistance. Cancer Metastasis Rev. 2007 Mar;26(1):39-57. Review. PubMed PMID: 17323127.

69: Marcus R. Use of rituximab in patients with follicular lymphoma. Clin Oncol (R Coll Radiol). 2007 Feb;19(1):38-49. Review. PubMed PMID: 17305253.

70: Esteve J, Escoda L, Martín G, Rubio V, Díaz-Mediavilla J, González M, Rivas C, Alvarez C, González San Miguel JD, Brunet S, Tomás JF, Tormo M, Sayas MJ, Sánchez Godoy P, Colomer D, Bolufer P, Sanz MA; Spanish Cooperative Group PETHEMA. Outcome of patients with acute promyelocytic leukemia failing to front-line treatment with all-trans retinoic acid and anthracycline-based chemotherapy (PETHEMA protocols LPA96 and LPA99): benefit of an early intervention. Leukemia. 2007 Mar;21(3):446-52. Epub 2007 Jan 4. PubMed PMID: 17205057.

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72: Honma H. [Successful treatment of an elderly patient with pretreated recurrent breast cancer using low-dose capecitabine]. Gan To Kagaku Ryoho. 2006 Dec;33(13):2045-8. Japanese. PubMed PMID: 17197750.

73: Collins R, Fenwick E, Trowman R, Perard R, Norman G, Light K, Birtle A, Palmer S, Riemsma R. A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer. Health Technol Assess. 2007 Jan;11(2):iii-iv, xv-xviii, 1-179. Review. PubMed PMID: 17181985.

74: Ladetto M, Magni M, Pagliano G, De Marco F, Drandi D, Ricca I, Astolfi M, Matteucci P, Guidetti A, Mantoan B, Bodoni CL, Zanni M, Boccadoro M, Gianni AM, Tarella C. Rituximab induces effective clearance of minimal residual disease in molecular relapses of mantle cell lymphoma. Biol Blood Marrow Transplant. 2006 Dec;12(12):1270-6. PubMed PMID: 17162208.

75: Marelli L, Stigliano R, Triantos C, Senzolo M, Cholongitas E, Davies N, Tibballs J, Meyer T, Patch DW, Burroughs AK. Transarterial therapy for hepatocellular carcinoma: which technique is more effective? A systematic review of cohort and randomized studies. Cardiovasc Intervent Radiol. 2007 Jan-Feb;30(1):6-25. Review. PubMed PMID: 17103105.

76: Goy A. New directions in the treatment of mantle cell lymphoma: an overview. Clin Lymphoma Myeloma. 2006 Oct;7 Suppl 1:S24-32. Review. PubMed PMID: 17101070.

77: Lucas A, Petrylak DP. The case for early chemotherapy for the treatment of metastatic disease. J Urol. 2006 Dec;176(6 Pt 2):S72-5. Review. PubMed PMID: 17084173.

78: de Labarthe A, Rousselot P, Huguet-Rigal F, Delabesse E, Witz F, Maury S, Réa D, Cayuela JM, Vekemans MC, Reman O, Buzyn A, Pigneux A, Escoffre M, Chalandon Y, MacIntyre E, Lhéritier V, Vernant JP, Thomas X, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). Imatinib combined with induction or consolidation chemotherapy in patients with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia: results of the GRAAPH-2003 study. Blood. 2007 Feb 15;109(4):1408-13. Epub 2006 Oct 24. PubMed PMID: 17062730.

79: Mike S, Harrison C, Coles B, Staffurth J, Wilt TJ, Mason MD. Chemotherapy for hormone-refractory prostate cancer. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005247. Review. PubMed PMID: 17054249.

80: Seamon JA, Rugg CA, Emanuel S, Calcagno AM, Ambudkar SV, Middleton SA, Butler J, Borowski V, Greenberger LM. Role of the ABCG2 drug transporter in the resistance and oral bioavailability of a potent cyclin-dependent kinase/Aurora kinase inhibitor. Mol Cancer Ther. 2006 Oct;5(10):2459-67. PubMed PMID: 17041089.

81: Petrylak DP. The treatment of hormone-refractory prostate cancer: docetaxel and beyond. Rev Urol. 2006;8 Suppl 2:S48-55. PubMed PMID: 17021642; PubMed Central PMCID: PMC1578715.

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