Clinical challenges associated with bortezomib therapy in multiple myeloma and Waldenströms Macroglobulinemia

Leukemia and Lymphoma

Volumn 50, Issue 5, 2009, Pages 694-702

  Laubach, Jacob P ^a   Mitsiades, Constantine S ^a   Roccaro, Aldo M ^a   Ghobrial, Irene M ^a   Anderson, Kenneth C ^a   Richardson, Paul G ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Clinical result; Drug resistance; Myeloma; Pharmacotherapeutics

Indexed keywords

ANTINEOPLASTIC AGENT; BORTEZOMIB; CISPLATIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; ETOPOSIDE; LENALIDOMIDE; MELPHALAN; POMALIDOMIDE; PR 171; PREDNISONE; PYRIDOXINE; SALINOSPORAMIDE A; THALIDOMIDE; THIOCTIC ACID; UNCLASSIFIED DRUG; VINCRISTINE;

AUTOLOGOUS STEM CELL TRANSPLANTATION; CLINICAL TRIAL; CYTOTOXICITY; DEEP VEIN THROMBOSIS; DIET SUPPLEMENTATION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG MEGADOSE; DRUG POTENCY; DRUG POTENTIATION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENT FREE SURVIVAL; HODGKIN DISEASE; HUMAN; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEUROPATHIC PAIN; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHARMACOLOGICAL BLOCKING; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW; THROMBOCYTOPENIA; WALDENSTROEM MACROGLOBULINEMIA;

ANTINEOPLASTIC AGENTS; BORONIC ACIDS; DRUG RESISTANCE, NEOPLASM; HUMANS; MULTIPLE MYELOMA; PROTEASE INHIBITORS; PYRAZINES; WALDENSTROM MACROGLOBULINEMIA;

EID: 68449098101     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.1080/10428190902866732     Document Type: Review

References (68)

1. Boccadoro M, Morgan G, Cavenagh J. Preclinical evaluation of the proteasome inhibitor bortezomib in cancer therapy. Cancer Cell Int 2005;5:18.
2. Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 2005;352:2487-2498.
3. San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 2008;359:906-917.
4. Kastritis E, Migkou M, Gavriatopoulou M, Zirogiannis P, Hadjikonstantinou V, Dimopoulos MA. Treatment of light chain deposition disease with bortezomib and dexamethasone. Haematologica 2009;94:300-302.
5. Hess G, Wagner V, Kreft A, Heussel CP, Huber C. Effects of bortezomib on pro-inflammatory cytokine levels and transfusion dependency in a patient with multicentric Castleman disease. Br J Haematol 2006;134:544-545.
6. Wechalekar AD, Lachmann HJ, Offer M, Hawkins PN, Gillmore JD. Efficacy of bortezomib in systemic AL amyloidosis with relapsed/refractory clonal disease. Haematologica 2008;93:295-298.
7. Kastritis E, Anagnostopoulos A, Roussou M, Toumanidis S, Pamboukas C, Migkou M, et al. Treatment of light chain (AL) amyloidosis with the combination of bortezomib and dexamethasone. Haematologica 2007;92:1351-1358.
8. Dimopoulos MA, Anagnostopoulos A, Kyrtsonis MC, Castritis E, Bitsaktsis A, Pangalis GA. Treatment of relapsed or refractory Waldenströms Macroglobulinemia with bortezomib. Haematologica 2005;90:1655-1658.
9. Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, et al. Bortezomib is active in patients with untreated or relapsed Waldenströms Macroglobulinemia: A phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25:1570-1575.
10. Treon SP, Hunter ZR, Matous J, Joyce RM, Mannion B, Advani R, et al. Multicenter clinical trial of bortezomib in relapsed/refractory Waldenstr_doms Macroglobulinemia: Results of WMCTG Trial 03-248. Clin Cancer Res 2007;13:3320-3325.
11. Richardson PG, Sonneveld P, Schuster M, Irwin D, Stadtmauer E, Facon T, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: Final time-toevent results of the APEX trial. Blood 2007;110:3557-3560.
12. Kropff MH, Bisping G, Wenning D, Volpert S, Tchinda J, Berdel WE, et al. Bortezomib in combination with dexamethasone for relapsed multiple myeloma. Leuk Res 2005;29:587-590.
13. Richardson PG, BarlogieB, Berenson J, Singhal S, Jagannath S, Irwin D, et al. Clinical factors predictive of outcome with bortezomib in patients with relapsed, refractory multiple myeloma. Blood 2005;106:2977-2981.
14. Chang H, Trieu Y, Qi X, Xu W, Stewart KA, Reece D. Bortezomib therapy response is independent of cytogenetic abnormalities in relapsed/ refractory multiple myeloma. Leuk Res 2007;31:779-782.
15. Jagannath S, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, et al. Bortezomib appears to overcome the poor prognosis conferred by chromosome 13 deletion in phase 2 and 3 trials. Leukemia 2007;21:151-157.
16. Mulligan G, Mitsiades C, Bryant B, Zhan F, Chng WJ, Roels S, et al. Gene expression profiling and correlation with outcome in clinical trials of the proteasome inhibitor bortezomib. Blood 2007;109:31773188.
17. Oerlemans R, Franke NE, Assaraf YG, Cloos J, van Zantwijk I, Berkers CR, et al. Molecular basis of bortezomib resistance: Proteasome subunit beta5 (PSMB5) gene mutation and overexpression of PSMB5 protein. Blood 2008;112:2489-2499.
18. Wang L, Kumar S, Fridley BL, Kalari KR, Moon I, Pelleymounter LL, et al. Proteasome beta subunit pharmacogenomics: Gene resequencing and functional genomics. Clin Cancer Res 2008;14:3503-3513.
19. Politou M, Karadimitris A, Terpos E, Kotsianidis I, Apperley JF, Rahemtulla A. No evidence of mutations of the PSMB5 (beta-5 subunit of proteasome) in a case of myeloma with clinical resistance to Bortezomib. Leuk Res 2006; 30:240-241.
20. Mitsiades N, Mitsiades CS, Richardson PG, Poulaki V, Tai YT, Chauhan D, et al. The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications. Blood 2003;101:2377-2380.
21. Ma MH, Yang HH, Parker K, Manyak S, Friedman JM, Altamirano C, et al. The proteasome inhibitor PS-341 markedly enhances sensitivity of multiple myeloma tumor cells to chemotherapeutic agents. Clin Cancer Res 2003;9: 1136-1144.
22. Mitsiades N, Mitsiades CS, Richardson PG, McMullan C, Poulaki V, Fanourakis G, et al. Molecular sequelae of histone deacetylase inhibition in human malignant B cells. Blood 2003;101:4055-4062.
23. Orlowski RZ, Voorhees PM, Garcia RA, Hall MD, Kudrik FJ, Allred T, et al. Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies. Blood 2005;105: 3058-3065.
24. Orlowski RZ, Nagler A, Sonneveld P, Blade J, Hajek R, Spencer A, 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;25:3892-3901.
25. Oakervee HE, Popat R, Curry N, Smith P, Morris C, Drake M, et al. PAD combination therapy (PS-341/bortezomib, doxorubicin and dexamethasone) for previously untreated patients with multiple myeloma. Br J Haematol 2005;129: 755-762.
26. Mitsiades N, Mitsiades CS, Poulaki V, Chauhan D, Richardson PG, Hideshima T, et al. Apoptotic signaling induced by immunomodulatory thalidomide analogs in human multiple myeloma cells: Therapeutic implications. Blood 2002;99:4525-4530.
27. Richardson PG, Jagannath S, Avigan DE, Alsina M, Schlossman R, Mazumder A, et al. Lenalidomide plus bortezomib (Rev-Vel) in relapsed and/or refractory multiple myeloma (MM): Final results of a multicenter phase I trial. Abstract 108. In: American Society of Hematology, Annual Meeting; 2006.
28. Richardson P, Jagannath S, Raje N, Jakubowiak A, Lonial S, Ghobrial I, et al. Lenalidomide, bortezomib, and dexamethasone (Rev/Vel/Dex) in patients with relapsed or relapsed/refractory multiple myeloma (MM): preliminary results of a phase II study. Abstract 2714. In: American Society of Hematology, Annual Meeting; 2007.
29. Richardson P, Jagannath S, Raje N, Jakubowiak A, Lonial S, Avigan D, et al. Lenalidomide, bortezomib, and dexamethasone (Rev/Vel/Dex) as front-line therapy for patients with multiple myeloma (MM): Preliminary results of a phase 1/2 study. Abstract 187. In: American Society of Hematology, Annual Meeting; 2007.
30. Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 2003;348: 2609-2617.
31. Jagannath S, Barlogie B, Berenson J, Siegel D, Irwin D, Richardson PG, et al. A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol 2004;127:165-172.
32. Richardson PG, Briemberg H, Jagannath S, Wen PY, Barlogie B, Berenson J, et al. Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. J Clin Oncol 2006;24: 3113-3120.
33. Argyriou AA, Iconomou G, Kalofonos HP. Bortezomibinduced peripheral neuropathy in multiple myeloma: A comprehensive review of the literature. Blood 2008;112:1593-1599.
34. Windebank AJ, Grisold W. Chemotherapy-induced neuropathy. J Peripher Nerv Syst 2008;13:27-46.
35. Cavaletti G, Nobile-Orazio E. Bortezomib-induced peripheral neurotoxicity: Still far from a painless gain. Haematologica 2007;92:1308-1310.
36. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-655.
37. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-214.
38. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, et al. CTCAE v3.0: Development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003;13:176-181.
39. Cella D. Manual of the functional assessment of chronic illness therapy (FACIT) measurement system. 4th ed. Evanston, IL; 1997.
40. Packer L, Kraemer K, Rimbach G. Molecular aspects of lipoic acid in the prevention of diabetes complications. Nutrition 2001;17:888-895.
41. Amara S. Oral glutamine for the prevention of chemotherapyinduced peripheral neuropathy. Ann Pharmacother 2008; 42:1481-1485.
42. Wang WS, Lin JK, Lin TC, Chen WS, Jiang JK, Wang HS, et al. Oral glutamine is effective for preventing oxaliplatininduced neuropathy in colorectal cancer patients. Oncologist 2007;12:312-319.
43. De Grandis D. Acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy: A short review. CNS Drugs 2007;21(Suppl 1):39-43; discussion 5-6.
44. Ozyurek H, Turker H, Akbalik M, Bayrak AO, Ince H, Duru F. Pyridoxine and pyridostigmine treatment in vincristine- induced neuropathy. Pediatr Hematol Oncol 2007;24:447-452.
45. Cleary JF. The pharmacologic management of cancer pain. J Palliat Med 2007;10:1369-1394.
46. Lonial S, Waller EK, Richardson PG, Jagannath S, Orlowski RZ, Giver CR, et al. Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiple myeloma. Blood 2005;106:3777-3784.
47. Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med 1996;335:91-97.
48. Barlogie B, Jagannath S, Vesole DH, Naucke S, Cheson B, Mattox S, et al. Superiority of tandem autologous transplantation over standard therapy for previously untreated multiple myeloma. Blood 1997;89:789-793.
49. Blade J, Rosinol L, Sureda A, Ribera JM, Diaz-Mediavilla J, Garcia-Larana J, et al. High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy: Long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA. Blood 2005;106: 3755-3759.
50. Alexanian R, Weber D, Giralt S, Dimopoulos M, Delasalle K, Smith T, et al. Impact of complete remission with intensive therapy in patients with responsive multiple myeloma. Bone Marrow Transplant 2001;27:1037-1043.
51. Attal M, Harousseau JL, Facon T, Guilhot F, Doyen C, Fuzibet JG, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 2003; 349:2495-2502.
52. Cavo M, Tosi P, Zamagni E, Cellini C, Tacchetti P, Patriarca F, et al. Prospective, randomized study of single compared with double autologous stem-cell transplantation for multiple myeloma: Bologna 96 clinical study. J Clin Oncol 2007;25:2434-2441.
53. Harousseau JL, Palumbo A, Richardson P, Schlag R, Dimopoulos M, Shpilberg O, et al. Superior outcomes associated with complete response: analysis of the phase III Vista study of bortezomib plus melphalan-prednisone versus melphalan-prednisone. Abstract 2778. In: American Society of Hematology, Annual Meeting; 2008.
54. Koreth J, Cutler CS, Djulbegovic B, Behl R, Schlossman RL, Munshi NC, et al. High-dose therapy with single autologous transplantation versus chemotherapy for newly diagnosed multiple myeloma: A systematic review and meta-analysis of randomized controlled trials. Biol Blood Marrow Transplant 2007;13:183-196.
55. Harousseau JL, Mathiot C, Attal M, Marit G, Caillot D, Mohty M, et al. Velcade/dexamethasone (Vel/D) versus VAD as induction treartment prior to autologous stem cell transplantation (ASCT) in newly diagnosed multiple myeloma (MM): Updated results of the IFM 2005/01 trial. Abstract 450. In: American Society of Hematology Annual Meeting; 2007.
56. Sunwoo JB, Chen Z, Dong G, Yeh N, Crowl Bancroft C, Sausville E, et al. Novel proteasome inhibitor PS-341 inhibits activation of nuclear factor-kappa B, cell survival, tumor growth, and angiogenesis in squamous cell carcinoma. Clin Cancer Res 2001;7:1419-1428.
57. Cavo M, Tacchetti P, Patriarca F, Petrucci MT, Pantani L, Ceccolini M, et al. Superior complete response rate and progression-free survival after autologous transplantation with up-front velcade-thalidomide-dexamethasone compared with thalidomide-dexamethasone in newly diagnosed multiple myeloma. Abstract 1662. In: American Society of Hematology, Annual Meeting; 2008.
58. Barlogie B, Anaissie E, van Rhee F, Haessler J, Hollmig K, Pineda-Roman M, et al. Incorporating bortezomib into upfront treatment for multiple myeloma: Early results of total therapy 3. Br J Haematol 2007;138:176-185.
59. Barlogie B, Tricot G, Anaissie E, Shaughnessy J, Rasmussen E, van Rhee F, et al. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med 2006;354:1021-1030.
60. Attal M, Harousseau JL, Leyvraz S, Doyen C, Hulin C, Benboubker L, et al. Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood 2006;108:3289-3294.
61. Abdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, et al. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: Results of a multicenter randomized clinical trial. Blood 2008;111:1805-1810.
62. Sonneveld P, van der Holt B, Schmidt-Wolf IGH, Bertsch U, el Jarari L, Salwender HJ, et al. First analysis of HOVON-65/GMMG-HD4 randomized phase III trial comparing bortezomib, adriamycine, dexamethasone (PAD) vs VAD as induction treatment prior to high dose melphalan (HDM) in patients with newly diagnosed multiple myeloma (MM). Abstract 653. In: American Society of Hematology, Annual Meeting; 2008.
63. Chauhan D, Catley L, Li G, Podar K, Hideshima T, Velankar M, et al. A novel orally active proteasome inhibitor induces apoptosis in multiple myeloma cells with mechanisms distinct from Bortezomib. Cancer Cell 2005;8:407-419.
64. Richardson P, Hofmeister CC, Zimmerman TM, Chanan- Khan AA, Spear M, Palladino MAA, et al. Phase 1 clinical trial of NPI-0052, a novel proteasome inhibitor in patients with multiple myeloma. Abstract 2770. In: American Society of Hematology, Annual Meeting; 2008.
65. Demo SD, Kirk CJ, Aujay MA, Buchholz TJ, Dajee M, Ho MN, et al. Antitumor activity of PR-171, a novel irreversible inhibitor of the proteasome. Cancer Res 2007;67:6383-6391.
66. Vij R, Wang M, Orlowski R, Stewart AK, Jagannath S, Kukreti W, et al. Initial results of PX-171-004, an open-label, single-arm, phase II study of carfilzomib (CFZ) in patients with relapsed Myeloma (MM). Abstract 865). In: American Society of Hematology, Annual Meeting; 2008.
67. Jagannath S, Vij R, Stewart AK, Somlo G, Jakubowiak A, Reiman T, et al. Initial results of PX-171-003, an open-label, single-arm, phase II study of carfilzomib (CFZ) in patients with relapsed and refractory multiple myeloma (MM). Abstract 864. In: American Society of Hematology, Annual Meeting; 2008.
68. Roccaro AM, Leleu X, Sacco A, Jia X, Melhem M, Moreau AS, et al. Dual targeting of the proteasome regulates survival and homing in Waldenström Macroglobulinemia. Blood 2008;111:4752-4763.