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Drug Evaluations

Pharmacokinetic evaluation of oblimersen sodium for the treatment of chronic lymphocytic leukemia

, MD, , MD, , MD, , MD & (Associate Professor of Medicine and Oncology)
Pages 765-774 | Published online: 27 Apr 2011

Bibliography

  • Jemal A, Siegel R, Xu J, Ward E. Cancer statistics 2010. CA Cancer J Clin 2010;60:277-300
  • Altekruse S, Kosary C, Krapcho M, SEER Cancer Statistics Review, 1975-2007, National Cancer Institute. In 2010 edition. Bethesda, MD. Available from: http://seer.cancer.gov/csr/1975_2007/
  • Rai KR, Chiorazzi N. Determining the clinical course and outcome in chronic lymphocytic leukemia. N Engl J Med 2003;7:1797-9
  • Cheson BD. Oblimersen for the treatment of patients with chronic lymphocytic leukemia. Ther Clin Risk Manag 2007;3:855-70
  • Hallek M, Cheson BD, Catovsky D, Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008;111:5446-56
  • Flinn IW, Neuberg DS, Grever MR, Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol 2007;25:793-8
  • Catovsky D, Richards S, Matutes E, Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet 2007;370:230-9
  • Eichhorst BF, Busch R, Hopfinger G, Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood 2006;107:885-91
  • Byrd JC, Peterson BL, Morrison VA, Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood 2003;101:6-14
  • Keating MJ, O'Brien S, Albitar M, Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol 2005;23:4079-88
  • O'Brien S, Moore JO, Boyd TE, 5-year survival in patients with relapsed or refractory chronic lymphocytic leukemia in a randomized, phase III trial of fludarabine plus cyclophosphamide with or without oblimersen. J Clin Oncol 2009;27:5208-12
  • Robak T. Improving FCR immunochemotherapy in CLL. Blood 2010;115:437-8
  • Chanan-Khan AA. New treatments for chronic lymphocytic leukemia. Curr Oncol Rep 2007;9:353-60
  • Schena M, Larsson LG, Gottardi D, Growth- and differentiation-associated expression of bcl-2 in B-chronic lymphocytic leukemia cells. Blood 1992;79:2981-9
  • Hanada M, Delia D, Aiello A, Bcl-2 gene hypomethylation and high-level expression in B-cell chronic lymphocytic leukemia. Blood 1993;82:1820-8
  • Tracey L, Perez-Rosado A, Artiga MJ, Expression of the NF-kappaB targets BCL2 and BIRC5/Survivin characterizes small B-cell and aggressive B-cell lymphomas, respectively. J Pathol 2005;206:123-34
  • Robertson LE, Plunkett W, McConnell K, Bcl-2 expression in chronic lymphocytic leukemia and its correlation with the induction of apoptosis and clinical outcome. Leukemia 1996;10:456-9
  • Klobusicka M, Kusenda J, Babusikova O. Immunocytochemical detection of bcl-2 and p53 proteins in B-chronic lymphocytic leukemia patients. Neoplasma 2002;49:387-93
  • Menendez P, Vargas A, Bueno C, Quantitative analysis of bcl-2 expression in normal and leukemic human B-cell differentiation. Leukemia 2004;18:491-8
  • Aviram A, Rabizadeh E, Zimra Y, Expression of bcl-2 and bax in cells isolated from B-chronic lymphocytic leukemia patients at different stages of the disease. Eur J Haematol 2000;64:80-4
  • Zaja F, Di Loreto C, Amoroso V, BCL-2 immunohistochemical evaluation in B-cell chronic lymphocytic leukemia and hairy cell leukemia before treatment with fludarabine and 2-chloro-deoxy-adenosine. Leuk Lymphoma 1998;28:567-72
  • Wang HG, Reed JC. Mechanisms of Bcl-2 protein function. Histol Histopathol 1998;13:521-30
  • Reed JC. Bcl-2 family proteins: regulators of apoptosis and chemoresistance in hematologic malignancies. Semin Hematol 1997;34:9-19
  • McConkey DJ, Chandra J, Wright S, Apoptosis sensitivity in chronic lymphocytic leukemia is determined by endogenous endonuclease content and relative expression of BCL-2 and BAX. J Immunol 1996;156:2624-30
  • Thomas A, El Rouby S, Reed JC, Drug-induced apoptosis in B-cell chronic lymphocytic leukemia: relationship between p53 gene mutation and bcl-2/bax proteins in drug resistance. Oncogene 1996;12:1055-62
  • Patel MP, Masood A, Patel PS, Chanan-Khan AA. Targeting the Bcl-2. Curr Opin Oncol 2009;21:516-23
  • Cimmino A, Calin GA, Fabbri M, miR-15 and miR-16 induce apoptosis by targeting BCL2. Proc Natl Acad Sci USA 2005;102:13944-9
  • Calin GA, Ferracin M, Cimmino A, A MicroRNA signature associated with prognosis and progression in chronic lymphocytic leukemia. N Engl J Med 2005;353:1793-801
  • Pedersen IM, Kitada S, Leoni LM, Protection of CLL B cells by a follicular dendritic cell line is dependent on induction of Mcl-1. Blood 2002;100:1795-801
  • Burger JA, Tsukada N, Burger M, Blood-derived nurse-like cells protect chronic lymphocytic leukemia B cells from spontaneous apoptosis through stromal cell-derived factor-1. Blood 2000;96:2655-63
  • Burger M, Hartmann T, Krome M, Small peptide inhibitors of the CXCR4 chemokine receptor (CD184) antagonize the activation, migration, and antiapoptotic responses of CXCL12 in chronic lymphocytic leukemia B cells. Blood 2005;106:1824-30
  • Nishio M, Endo T, Tsukada N, Nurselike cells express BAFF and APRIL, which can promote survival of chronic lymphocytic leukemia cells via a paracrine pathway distinct from that of SDF-1alpha. Blood 2005;106:1012-20
  • Faderl S, Keating MJ, Do KA, Expression profile of 11 proteins and their prognostic significance in patients with chronic lymphocytic leukemia (CLL). Leukemia 2002;16:1045-52
  • Chanan-Khan A. Bcl-2 antisense therapy in B-cell malignancies. Blood Rev 2005;19:213-21
  • Stein CA, Benimetskaya L, Mani S. Antisense strategies for oncogene inactivation. Semin Oncol 2005;32:563-72
  • Cotter F. BCL-2 antisense therapy: in vitro, in vivo and human trial experiences in haematological malignancies. Naunyn-Schmiedebergs Arch Pharmacol 1998;358(Suppl 1):205
  • Rheingold SR, Hogarty MD, Blaney SM, Phase I Trial of G3139, a bcl-2 antisense oligonucleotide, combined with doxorubicin and cyclophosphamide in children with relapsed solid tumors: a Children's Oncology Group Study. J Clin Oncol 2007;25:1512-18
  • Marcucci G, Byrd JC, Dai G, Phase 1 and pharmacodynamic studies of G3139, a Bcl-2 antisense oligonucleotide, in combination with chemotherapy in refractory or relapsed acute leukemia. Blood 2003;101:425-32
  • Marcucci G, Stock W, Dai G, Phase I study of oblimersen sodium, an antisense to Bcl-2, in untreated older patients with acute myeloid leukemia: pharmacokinetics, pharmacodynamics, and clinical activity. J Clin Oncol 2005;23:3404-11
  • Demidov LV, Kharkevitch G, Itri LM, Frankel SR. A pharmacokinetic (PK) study of oblimersen sodium (G3139) + dacarbazine (DTIC) in patients with metastatic melanoma (MM). Proceedings of the 39th Annual Meeting, American Society of Clinical Oncologists; 31 May – 3 Jun 2003; Chicago, Illinois, United States. J Clin Oncol 2003;22:156
  • Tolcher AW, Chi K, Kuhn J, A Phase II, pharmacokinetic, and biological correlative study of oblimersen sodium and docetaxel in patients with hormone-refractory prostate cancer. Clin Cancer Res 2005;11:3854-61
  • O'Brien SM, Cunningham CC, Golenkov AK, Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol 2005;23:7697-702
  • Klasa RJ, Gillum AM, Klem RE, Frankel SR. Oblimersen Bcl-2 antisense: facilitating apoptosis in anticancer treatment. Antisense Nucleic Acid Drug Dev 2002;12:193-213
  • Yu R. Pharmacokinetic properties in humans. 2nd edition. CRC Press, New York; 2002
  • Auer R, Corbo M, Fegan C. Bcl-2 antisense (Genasense™) induces apoptosis and potentiates activity of both cytotoxic chemotherapy and rituximab in primary CLL cells [abstract 3358]. Proceedings of the 43rd Annual Meeting. Am Soc Hematol Blood 2001;98:808a
  • Joshi S, Wang P, Dickinson J. Manipulation of differentially expressed genes such as bcl-2 leads to increased killing of B chronic lymphocytic leukemia [abstract 3547]. Proc Am Assoc Cancer Res 2001;42:659
  • Mavromatis B, Rai KR, Wallace PK, Efficacy and Safety of the Combination of Genasense™ (Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated and Untreated Subjects with Chronic Lymphocytic Leukemia. ASH Annual Meeting Abstracts 2005;106: 2129
  • Marvromatis B, Rai K, Wallace PK, Impact of prognostic markers on outcomes in patients with advanced chronic lymphocytic leukemia treated with the regimen of fludarabine/rituximab plus oblimersen (Bcl-2 Antisense) [abstract 6609]. 2006 ASCO Annual Meeting Proceedings; 2006. p. 24
  • Rai KR, Moore J, Boyd TE. Chemotherapy with or without oblimersen sodium (Bcl-2 antisense; Genasense®; G3139) in advanced chronic lymphocytic leukemia: report of a large randomized study. Leuk Lymphoma 2005;46(Suppl 1):S16
  • O'Brien S, Moore JO, Boyd TE, Randomized phase III trial of fludarabine plus cyclophosphamide with or without oblimersen sodium (Bcl-2 antisense) in patients with relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol 2007;25:1114-20

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