Pegylated liposomal doxorubicin: A review of its use in the treatment of relapsed or refractory multiple myeloma

Drugs

Volumn 68, Issue 17, 2008, Pages 2535-2551

  Plosker, Greg L ^a,b  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b WOLTERS KLUWER HEALTH   (United States)

Author keywords

Adis Drug Evaluations; Doxorubicin liposomal, general; Multiple myeloma

Indexed keywords

BORTEZOMIB; DEXAMETHASONE; DOCETAXEL; DOXORUBICIN; LENALIDOMIDE; PACLITAXEL; THALIDOMIDE; VINCRISTINE;

ALOPECIA; ANEMIA; ANOREXIA; ASTHENIA; BONE MARROW SUPPRESSION; CANCER RELAPSE; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONGESTIVE HEART FAILURE; CONSTIPATION; COUGHING; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG USE; FEVER; GASTROINTESTINAL SYMPTOM; HAND FOOT SYNDROME; HEADACHE; HEART ARRHYTHMIA; HEART MUSCLE ISCHEMIA; HUMAN; MULTIPLE MYELOMA; NAUSEA; NEURALGIA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; RASH; REVIEW; STOMATITIS; THROMBOCYTOPENIA; TISSUE DISTRIBUTION; VOMITING;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; DOXORUBICIN; DRUG RESISTANCE, NEOPLASM; HUMANS; MULTIPLE MYELOMA; NEOPLASM RECURRENCE, LOCAL; POLYETHYLENE GLYCOLS; PYRAZINES;

EID: 56549086779     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/0003495-200868170-00008     Document Type: Review

References (54)

1. American Cancer Society. Multiple myeloma [online]. Available from URL: http://documents.cancer.org/175.00/175.00.pdf [Accessed 2008 Aug 25]
2. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008; 58: 71-96
3. Sirohi B, Powles R. Multiple myeloma. Lancet 2004 Mar 13; 363: 875-87
4. Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med 2004 Oct 28; 351 (18): 1860-73
5. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann Oncol 2005 Mar; 16 (3): 481-8
6. Harousseau J-L, Dreyling M. Multiple myeloma: ESMO clinical recommendations for diagnosis, treatment and follow-up. ESMO Guidelines Working Group. Ann Oncol 2008; 19 Suppl. 2: ii55-7
7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: multiple myeloma V.2.2008 [online]. Available from URL: http://www.nccn.org [Accessed 2008 Aug 25]
8. European Medicines Agency (EMEA). Summary of product characteristics: Caelyx (doxorubicin hydrochloride in a pegylated liposomal formulation) [online]. Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/ Caelyx/H-089-PI.en.pdf [Accessed 2008 Aug 25]
9. Alza Corporation. Doxil® (doxorubicin HCl liposome injection) for intravenous infusion: US prescribing information [online]. Available from URL: http://www.doxiline.com [Accessed 2008 Aug 25]
10. Richardson PG, Sonneveld P, Schuster MW, et al. Borezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 2005 Jun 16; 352 (24): 2487-98
11. Vail DM, Amantea MA, Colbern GT, et al. Pegylated liposomal doxorubicin: proof of principle using preclinical animal models and pharmacokinetic studies. Semin Oncol 2004 Dec; 31 (6 Suppl. 13): 16-35
12. Vaage J, Mayhew E, Lasic D, et al. Therapy of primary and metastatic mouse mammary carcinomas with doxorubicin encapsulated in long circulating liposomes. Int J Cancer 1992; 51: 942-8
13. Voorhees PM, Orlowski RZ. Emerging data on the use of anthracyclines in combination with bortezomib in multiple myeloma. Clin Lymphoma Myeloma 2007 Apr; 7 Suppl. 4: S156-62
14. Small GW, Somasundaram S, Moore DT, et al. Repression of mitogen-activated protein kinase (MAPK) phosphatase-1 by anthracyclines contributes to their antiapoptotic activation of p44/42-MAPK. J Pharmacol Exp Ther 2003; 307 (3): 861-9
15. Small GW, Shi YY, Edmund NA, et al. Evidence that mitogen-activated protein kinase phosphatase-1 induction by proteasome inhibitors plays an antiapoptotic role. Mol Pharmacol 2004; 66 (6): 1478-90
16. Mitsiades N, Mitsiades CS, Richardson PG, et al. The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications. Blood 2003; 101 (6): 2377-80
17. Ma MH, Yang HH, Parker K, et al. The proteasome inhibitor PS-341 markedly enhances sensitivity of multiple myeloma tumor cells to chemotherapeutic agents. Clin Cancer Res 2003; 9: 1136-44
18. Orlowski RZ, Voorhees PM, Garcia RA, et al. Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies. Blood 2005 Apr 15; 105 (8): 3058-65
19. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clin Pharmacokinet 2003; 42 (5): 419-36
20. Gabizon A, Isacson R, Rosengarten O, et al. An open-label study to evaluate dose and cycle dependence of the pharmacokinetics of pegylated liposomal doxorubicin. Cancer Chemother Pharmacol 2008 Apr; 61 (4): 695-702
21. Hilger RA, Richly H, Grubert M, et al. Pharmacokinetics (PK) of a liposomal encapsulated fraction containing doxorubicin and of doxorubicin released from the liposomal capsule after intravenous infusion of Caelyx/Doxil. Int J Clin Pharmacol Ther 2005 Dec; 43 (12): 588-9
22. Briasoulis E, Karavasilis V, Tzamakou E, et al. Interaction pharmacokinetics of pegylated liposomal doxorubicin (Caelyx) on coadministration with paclitaxel or docetaxel. Cancer Chemother Pharmacol 2004 May; 53 (5): 452-7
23. Bozionelou V, Vamvakas L, Pappas P, et al. A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours. Br J Cancer 2007 Jul 2; 97 (1): 43-9
24. Pavlick AC, Chodkiewicz C, Liebes L, et al. A phase I and pharmacokinetic study of docetaxel combined with Doxil (pegylated liposomal doxorubicin) without and with granulocyte colony stimulating factor. Anticancer Drugs 2004 Feb; 15 (2): 119-25
25. Airoldi M, Cattel L, Milla P, et al. Paclitaxel and pegylated liposomal doxorubicin in recurrent head and neck cancer: clinical and unexpected pharmacokinetic interactions. Anticancer Res 2008; 28 (4C): 2519-27
26. von Mehren M, Schilder RJ, Cheng JD, et al. A phase I study of the safety and pharmacokinetics of trabectedin in combination with pegylated liposomal doxorubicin in patients with advanced malignancies. Ann Oncol 2008 Oct; 19 (10): 1802-9
27. Orlowski RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol 2007 Sep 1; 25 (25): 3892-901
28. Spencer A, Hajek R, Nagler A, et al. Pegylated liposomal doxorubicin + bortezomib in previously treated high-risk multiple myeloma [poster]. HOPA/ISOPP 2008 Conference; 2008 Jun 18-21; Anaheim (CA)
29. Sutherland JH, Blade J, San Miguel J, et al. Effect of disease stage and time since diagnosis on time to progression for pegylated liposomal doxorubicin + bortezomib vs bortezomib alone in relapsed or refractory multiple myeloma [abstract no. 2740]. Blood (ASH Annual Meeting Abstracts) 2007; 110: 805. Plus poster presented at the American Society of Hematology 49th Annual Meeting and Exposition; 2007 Dec 8-11; Atlanta (GA)
30. Sonneveld P, Hajek R, Nagler A, et al. Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. Cancer 2008 Apr 1; 112 (7): 1529-37
31. Blade J, San Miguel J, Nagler A, et al. The prolonged time to progression with pegylated liposomal doxorubicin + bortezomib versus bortezomib alone in relapsed or refractory multiple myeloma is unaffected by extent of prior therapy or previous anthracycline exposure [abstract no. 410]. Blood 2007 Nov 16; 110 (11): 127
32. Kumar S, Blade J, San Miguel J, et al. Pegylated liposomal doxorubicin in combination with bortezomib may provide therapeutic advantage for high-risk multiple myeloma patients relapsing within 12 months of stem cell transplant [abstract no. 2730]. Blood 2007 Nov 16; 110 (11): 802
33. Blade J, Sonneveld P, San Miguel J, et al. The effect of pegylated liposomal doxorubicin plus bortezomib in multiple myeloma patients with renal insufficiency [abstract plus poster]. Lymphoma & Myeloma 2008: An International Congress on Hematologic Malignancies; 2008 Oct 16-18; New York (NY)
34. San-Miguel JF, Hajek R, Nagler A, et al. Pegylated liposomal doxorubicin + bortezomib in previously treated multiple myeloma patients aged > 65 years [poster]. HOPA/ISOPP 2008 Conference; 2008 Jun 18-21; Anaheim (CA)
35. Hussein MA, Baz R, Srkalovic G, et al. Phase 2 study of pegylated liposomal doxorubicin, vincristine, decreased-frequency dexamethasone, and thalidomide in newly diagnosed and relapsed-refractory multiple myeloma. Mayo Clin Proc 2006 Jul; 81 (7): 889-95
36. Baz R, Walker E, Karam MA, et al. Lenalidomide and pegylated liposomal doxorubicin-based chemotherapy for relapsed or refractory multiple myeloma: safety and efficacy. Ann Oncol 2006 Dec; 17 (12): 1766-71
37. Offidani M, Corvatta L, Marconi M, et al. Low-dose thalidomide with pegylated liposomal doxorubicin and high-dose dexamethasone for relapsed/refractory multiple myeloma: a prospective, multicenter, phase II study. Haematologica 2006 Jan; 91 (1): 133-6
38. Offidani M, Bringhen S, Corvatta L, et al. Thalidomide-dexamethasone plus pegylated liposomal doxorubicin vs. thalidomide-dexamethasone: a case-matched study in advanced multiple myeloma. Eur J Haematol 2007; 78 (4): 297-302
39. Palumbo A, Gay F, Bringhen S, et al. Bortezomib, doxorubicin and dexamethasone in advanced multiple myeloma. Ann Oncol 2008 Jun; 19 (6): 1160-5
40. Jakubowiak AJ, Brackett L, Kendall T, et al. Combination therapy with Velcade, Doxil, and dexamethasone for patients with relapsed/refractory multiple myeloma [abstract no. 5179]. Blood 2005 Nov 16; 106 (11 Pt 2): 378
41. Chanan-Khan AA, Padmanabhan S, Miller KC, et al. Final results of a phase II study of bortezomib (Velcade) in combination with liposomal doxorubicin (Doxil) and thalidomide demonstrate a sustained high response rates in patients with relapsed or refractory multiple myeloma [abstract no.3539]. Blood 2006 Nov; 108 (11 Pt 1): 1010a
42. Porter CA, Rifkin RM. Clinical benefits and economic analysis of pegylated liposomal doxorubicin/vincristine/dexamethasone versus doxorubicin/vincristine/dexamethasone in patients with newly diagnosed multiple myeloma. Clin Lymphoma Myeloma 2007 Apr; 7 Suppl. 4: S150-5
43. Dimopoulos MA, Pouli A, Zervas K, et al. Prospective randomized comparison of vincristine, doxorubicin and dexamethasone (VAD) administered as intravenous bolus injection and VAD with liposomal doxorubicin as first-line treatment in multiple myeloma. Ann Oncol 2003 Jul; 14 (7): 1039-44
44. Rifkin RM, Gregory SA, Mohrbacher A, et al. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a phase III multicenter randomized trial. Cancer 2006 Feb 15; 106 (4): 848-58
45. O'Brien ME, Wigler N, Inbar M, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (Caelyx/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15: 440-9
46. Safra T, Muggia F, Jeffers S, et al. Pegylated liposomal doxorubicin (Doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2. Ann Oncol 2000; 11: 1029-33
47. Berry G, Billingham M, Alderman E, et al. The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 1998; 9: 711-6
48. Weber DM, Chen C, Niesvizky R, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 2007 Nov 22; 357 (21): 2133-42
49. Warrington TP, Bostwick JM. Psychiatric adverse effects of corticosteroids. Mayo Clin Proc 2006; 81 (10): 1361-7
50. Cerullo MA. Expect psychiatric side effects from corticosteroid use in the elderly. Geriatrics 2008 Jan; 63 (1): 15-8
51. Tripathi RC, Parapuram SK, Tripathi BJ, et al. Corticosteroids and glaucoma risk. Drugs Aging 1999 Dec; 15 (6): 439-50
52. Kersey JP, Broadway DC. Corticosteroid-induced glaucoma: a review of the literature. Eye 2006 Apr; 20 (4): 407-16
53. Blackburn D, Hux J, Mamdani M. Quantification of the risk of corticosteroid-induced diabetes mellitus among the elderly. J Gen Intern Med 2002; 17: 717-20
54. Jagannath S, Richardson PG, Barlogie B, et al. Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone. Haematologica 2006 Jul; 91 (7): 929-34