Bendamustine: A review of its use in the management of indolent non-hodgkin's lymphoma and mantle cell lymphoma

Drugs

Volumn 70, Issue 13, 2010, Pages 1703-1718

  Garnock Jones, Karly P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Bendamustine, general; Mantle cell lymphoma, treatment; Non Hodgkins lymphoma

Indexed keywords

BENDAMUSTINE; BORTEZOMIB; CLADRIBINE; CYCLOPHOSPHAMIDE; DOXORUBICIN; FLUDARABINE; GEMCITABINE; MITOXANTRONE; PREDNISONE; RITUXIMAB; VINCRISTINE;

ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BLEEDING; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; CONSTIPATION; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED CANCER; DRUG MECHANISM; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG TRANSFORMATION; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; KIDNEY DISEASE; LEUKOPENIA; LIVER DISEASE; LUNG HEMORRHAGE; LYMPHOCYTOPENIA; MANTLE CELL LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PANCYTOPENIA; PERIPHERAL NEUROPATHY; PNEUMONIA; PROGRESSION FREE SURVIVAL; RECOMMENDED DRUG DOSE; RESPIRATORY FAILURE; REVIEW; SEPSIS; SIDE EFFECT; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE; TUMOR LYSIS SYNDROME; UNSPECIFIED SIDE EFFECT; VIRUS PNEUMONIA;

ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; LYMPHOMA, MANTLE-CELL; LYMPHOMA, NON-HODGKIN; NITROGEN MUSTARD COMPOUNDS;

EID: 77956079876     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11205860-000000000-00000     Document Type: Review

References (57)

1. Ekstrom-Smedby K. Epidemiology and etiology of non-Hodgkin lymphoma: a review. Acta Oncol 2006; 45 (3): 258-271
2. Aldoss IT, Blumel SM, Bierman PJ. The role of bendamus-tine in the treatment of indolent non-Hodgkin lymphoma. Cancer Management and Research 2009; 1: 155-165
3. Merck. Non-Hodgkin lymphomas: Merck manual professio-nal [online]. Available from URL: http://www.merck.com/mmpe/sec11/ch143/ch143c.html [Accessed 2010 May 6]
4. Goy A. Mantle cell lymphoma: Evolving novel options. Curr Oncol Rep 2007; 9 (5): 391-398
5. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: non-Hodgkin's lymphomas (V.1.2010) [online]. Available from URL: http://www.nccn.org/pro fessionals/physician-gls/PDF/nhl.pdf [Accessed 2010 May 6]
6. World Health Organisation. GLOBOCAN 2008: cancer in-cidence and mortality worldwide in 2008 [online]. Available from URL: http://globocan.iarc.fr/ [Accessed 2010 Aug 5]
7. American Cancer Society. Detailed guide: lymphoma, non-hodgkin type [online]. Available from URL: http://www. cancer.org/docroot/CRI/CRI-2-1x.asp? rnav=criov&dt=32 [Accessed 2010 May 6]
8. Tageja N, Nagi J. Bendamustine: something old, something new. Cancer Chemother Pharmacol 2010 Apr 8
9. National Cancer Institute. Adult non-Hodgkin lymphoma treatment (PDQ®): health professional version [online]. Available from URL: http://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins [Accessed 2010 May 7]
10. Cheson BD, Ashforth E. Newer strategies for overcoming rituximab resistance in non-Hodgkins lymphoma and chronic lymphocytic leukemia. Clin Adv Hematol Oncol 2009; 7 (2 Suppl. 5): 8-16
11. Cephalon Inc. Treanda® (bendamustine hydrochloride) for intravenous infusion: US prescribing information [online]. Available from URL: http://www.treanda.com/docs/TREANDA-final-P1.pdf [Accessed 2010 Apr 16]
12. Cheson BD, Wendtner CM, Pieper A, et al. Optimal use of bendamustine in chronic lymphocytic leukemia, non-Hodgkin lymphomas, and multiple myeloma: treatment recommendations from an international consensus panel. Clin Lymphoma Myeloma Leuk 2010 Feb; 10 (1): 21-27
13. Cephalon Inc. Cephalon receives FDA approval for Trean-da to treat patients with relapsed indolent non-Hodgkin's lymphoma [media release]. 2008 Oct 31 [online]. Available from URL: http://www.cephalon.com/media/news-releases/ [Accessed 2010 May 7]
14. SymBio Pharmaceuticals Limited. Bendamustine HCl (SyB L-0501) approved in Singapore and Hong Kong-gains momentum for business expansion in Asia Pacific [online]. Available from URL: http://www.symbiopharma.com/en/news/100127e.pdf [Accessed 2010 Jul 29].
15. European Medicines Agency. Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) [online]. Available from URL: http://www.ema.europa.eu/ pdfs/human/referral/Levact/ha-291238q&a.pdf [Accessed 2010 May 21]
16. Plosker GL, Carter NJ. Bendamustine: a review of its use in the management of indolent non-Hodgkin lymphoma. Drugs 2008; 68 (18): 2645-2660
17. Barman Balfour JA, Goa KL. Bendamustine. Drugs 2001; 61 (5): 631-638
18. Gandhi V. Metabolism and mechanisms of action of ben-damustine: rationales for combination therapies. Semin Oncol 2002 Aug; 29 (4 Suppl. 13): 4-11
19. Konstantinov SM, Kostovski A, Topashka-Ancheva M, et al. Cytotoxic efficacy of bendamustine in human leukemia and breast cancer cell lines. J Cancer Res Clin Oncol 2002 May; 128 (5): 271-278
20. Schwanen C, Hecker T, Hubinger G, et al. In vitro evalua-tion of bendamustine induced apoptosis in B-chronic lym-phocytic leukemia. Leukemia 2002 Oct; 16 (10): 2096-2105
21. Nowak D, Boehrer S, Brieger A, et al. Upon drug-induced apoptosis in lymphoma cells X-linked inhibitor of apop-tosis (XIAP) translocates from the cytosol to the nucleus. Leuk Lymphoma 2004 Jul; 45 (7): 1429-1436
22. Roue G, Lopez-Guerra M, Milpied P, et al. Bendamustine is effective in p53-deficient B-cell neoplasms and requires oxidative stress and caspase-independent signaling. Clin Cancer Res 2008 Nov 1; 14 (21): 6907-6915
23. Leoni LM, Bailey B, Reifert J, et al. Bendamustine (Trean-da) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res 2008 Jan; 14 (1): 309-317
24. Chow KU, Boehrer S, Geduldig K, et al. In vitro induction of apoptosis of neoplastic cells in low-grade non-Hodgkin's lymphomas using combinations of established cytotoxic drugs with bendamustine. Haematologica 2001 May; 86 (5): 485-493
25. Zong W-X, Ditsworth D, Bauer DE, et al. Alkylating DNA damage stimulates a regulated form of necrotic cell death. Genes Dev 2004; 18: 1272-1282
26. Strumberg D, Harstrick A, Doll K, et al. Bendamustine hydrochloride activity against doxorubicin-resistant human breast carcinoma cell lines. Anticancer Drugs 1996 Jun;7(4): 415-421
27. Chow KU, Nowak D, Boehrer S, et al. Synergistic effects of chemotherapeutic drugs in lymphoma cells are associated with down-regulation of inhibitor of apoptosis proteins (IAPs), prostate-apoptosis-response-gene 4 (Par-4), death-associated protein (Daxx) and with enforced caspase activation. Biochem Pharmacol 2003; 66: 711-724
28. Chow KU, Sommerlad WD, Boehrer S, et al. Anti-CD20 antibody (IDEC-C2B8, rituximab) enhances efficacy of cytotoxic drugs on neoplastic lymphocytes in vitro: role of cytokines, complement, and caspases. Haematologica 2002; 87: 33-43
29. Kanekal S, Crain B, Elliott G. SDX-105 (Treanda™) en-hances the tumour growth inhibitory effect of rituximab in Daudi lymphoma xenografts [abstract no. 4580]. Blood 2004; 104: 229b
30. Schoffski P, Seeland G, Engel H, et al. Weekly administration of bendamustine: a phase I study in patients with advanced progressive solid tumours. Ann Oncol 2000 Jun; 11 (6): 729-734
31. Kath R, Blumenstengel K, Fricke HJ, et al. Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia. J Cancer Res Clin Oncol 2001 Jan; 127 (1): 48-54
32. Gaul L, Mandl-Weber S, Baumann P, et al. Bendamustine induces G2 cell cycle arrest and apoptosis in myeloma cells: the role of ATM-Chk2-Cdc25A and ATM-p53-p21-path-ways. J Cancer Res Clin Oncol 2008 Feb; 134 (2): 245-253
33. Ogura M, Uchida T, Taniwaki M, et al. Phase I and pharm-acokinetic study of bendamustine hydrochloride in relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Science. Epub 2010 May 27
34. Rasschaert M, Schrijvers D, Van Den Brande J, et al. A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors. Anticancer Drugs 2007; 18: 587-595 (Pubitemid 46597413)
35. Rasschaert M, Schrijvers D, Van Den Brande J. A phase I study of bendamustine hydrochloride administered day 1 + 2 every 3 weeks in patients with solid tumours. Br J Cancer 2007; 96: 1692-1698 (Pubitemid 46847200)
36. Owen JS, Melhem M, Passarell JA, et al. Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin's lymphoma. Cancer Chemother Pharmacol 2010 Feb 6
37. Teichert J, Baumann F, Chao Q, et al. Characterization of two phase I metabolites of bendamustine in human liver microsomes and in cancer patients treated with bendamustine hydrochloride. Cancer Chemother Pharmacol 2007; 59: 759-770
38. Teichert J, Sohr R, Baumann F, et al. Synthesis and char-acterization of some new phase II metabolites of the alky-lator bendamustine and their identification in human bile, urine and plasma from patients with cholangiocarcinoma. Drug Metab Dispos 2005; 33 (7): 984-992
39. Heider A, Niederle N. Efficacy and toxicity of bendamustine in patients with relapsed low-grade non-Hodgkin's lymphomas. Anticancer Drugs 2001 Oct; 12 (9): 725-729
40. Heider A, Kress M, Niederle N. Bendamustin as second-line therapy in patients with relapsed low grade non-Hodgkin's lymphoma and multiple myeloma [in German]. Tumor Diagnostik Und Therapie 1997; 18 (3): 71-75
41. Omachi K, Ando K, Ogura M, et al. Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Science. Epub 2010 May 29
42. Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a multicenter study. Cancer 2010; 116 (1): 106-114
43. Friedberg JW, Cohen P, Chen L, et al. Bendamustine in pa-tients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multi-center, single-agent study [published erratum appears in J Clin Oncol 2008 Apr; 26 (11): 1911]. J Clin Oncol 2008 Jan; 26 (2): 204-210
44. Herold M, Schulze A, Niederwieser D, et al. Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). J Cancer Res Clin Oncol 2006 Feb; 132 (2): 105-112
45. Rummel MJ, Niederle N, Maschmeyer G, et al. Benda-mustine plus rituximab is superior in respect of progression free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany) [abstract no. 405]. Blood 2009 Nov; 114 (22): 168
46. Rummel MJ, Al-Batran SE, Kim SZ, et al. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol 2005 May; 23 (15): 3383-3389
47. Rummel MJ, Atta J, Welslau M, et al. Bendamustine and rituximab are effective in the treatment of relapsed or refractory indolent and mantle-cell lymphoma: long-term follow-up of a phase II study [abstract no. 8034]. J Clin Oncol 2007 Jun; 25 (18 Suppl.): 449
48. Robinson KS, Williams ME, van der Jagt RH, et al. Phase II multicenter study ofbendamustine plus rituximab inpatients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol 2008 Sep; 26 (27): 4473-4479
49. Weide R, Hess G, Koppler H, et al. High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in ritux-imab pretreated relapsed or refractory indolent lymph-omas and mantle cell lymphomas: a multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG). Leuk Lymphoma 2007 Jul; 48 (7): 1299-1306
50. Dreyling M. Newly diagnosed and relapsed follicular lym-phoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009; 20 Suppl. 4: iv119-20
51. Hagemeister F. Rituximab for the treatment ofnon-Hodgkin's lymphoma and chronic lymphocytic leukaemia. Drugs 2010 Feb 12; 70 (3): 261-272
52. Cheson BD, Kroll ML. Bendamustine induced neurotoxi-city. Clin Adv Hematol Oncol 2009 Nov; 7 (11): 743-746
53. Cephalon Inc. Study of bendamustine hydrochloride and rituximab (BR) compared with R-CVP or R-CHOP in the first-line treatment of patientswith advanced indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL)-referred to as the BRIGHT study [ClinicalTrials. gov identifier NCT00877006]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 May 20]
54. Genentech. A study to investigate the efficacy and safety of bendamustine compared with bendamustine+RO5072759 (GA101) in patients with rituximab-refractory, indolent non-Hodgkin's lymphoma (GADOLIN) [ClinicalTrials.gov identifier NCT01059630]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 May 24]
55. GlaxoSmithKline. Ofatumumab and bendamustine combi-nation therapy compared with bendamustine monotherapy in indolent B-cell non-Hodgkin's lymphoma (NHL) unresponsive to rituximab or a rituximab-containing regimen (COMPLEMENT A+B) [ClinicalTrials.gov identifier NCT01077518]. US National Institutes of Health, Clinical Trials.gov [online]. Available from URL: http://clinicaltrials. gov [Accessed 2010 May 24]
56. Koenigsmann M, Knauf WU, Herold M, et al. Fludarabine and bendamustine in refractory and relapsed indolent lymphoma:a multicenter phase I/II trial of the East German Society of Hematology and Oncology (OSHO). Leuk Lymphoma 2004; 45 (9): 1821-1827
57. Moosmann P, Heizmann M, Kotrubczik N, et al. Weekly treatment with a combination of bortezomib and benda-mustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma 2010; 51 (1): 149-52