A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse

Leukemia Research - Tập 30 - Trang 777-783 - 2006
Joseph Moore1, Karen Seiter2, Jonathan Kolitz3, Wendy Stock4, Francis Giles5, Matt Kalaycio6, David Zenk7, Guido Marcucci8
1Duke University Medical Center, Morris Cancer Clinics, P.O. Box 3872, Durham, NC 27710, United States
2New York Medical College, Valhalla, NY, United States
3North Shore University Hospital, Manhasset, NY, United States
4The University of Chicago, Chicago, IL, United States
5University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States
6The Cleveland Clinic Foundation, Cleveland, OH, United States
7Iowa Blood and Cancer Center, Cedar Rapids, IA, United States
8Ohio State University Comprehensive Cancer Center, Columbus, OH, United States

Tài liệu tham khảo

Estey, 2000, How I treat older patients with AML, Blood, 96, 1670, 10.1182/blood.V96.5.1670 Berger, 2002, Licensure of gemtuzumab ozogamicin for the treatment of selected patients 60 years of age or older with acute myeloid leukemia in first relapse, Invest New Drugs, 20, 395, 10.1023/A:1020658028082 Bross, 2001, Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia, Clin Cancer Res, 7, 1490 Larson, 2002, Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin), Leukemia, 16, 1627, 10.1038/sj.leu.2402677 Karakas, 1998, High expression of bcl-2 mRNA as a determinant of poor prognosis in acute myeloid leukemia, Ann Oncol, 9, 159, 10.1023/A:1008255511404 Reed, 2003, Apoptosis-targeted therapies for cancer, Cancer Cell, 3, 17, 10.1016/S1535-6108(02)00241-6 Wu, 1996, Apoptotic death of tumor cells correlates with chemosensitivity, independent of p53 or bcl-2, Clin Cancer Res, 2, 623 Reed, 1999, Dysregulation of apoptosis in cancer, J Clin Oncol, 17, 2941, 10.1200/JCO.1999.17.9.2941 Cory, 2003, The Bcl-2 family: roles in cell survival and oncogenesis, Oncogene, 22, 8590, 10.1038/sj.onc.1207102 Adams, 2003, Ways of dying: multiple pathways to apoptosis, Genes Dev, 17, 2481, 10.1101/gad.1126903 Kim, 2002, Current status of the molecular mechanisms of anticancer drug-induced apoptosis. The contribution of molecular-level analysis to cancer chemotherapy, Cancer Chemother Pharmacol, 50, 343, 10.1007/s00280-002-0522-7 Makin, 2002, Targeting apoptosis in cancer chemotherapy, Expert Opin Ther Targets, 6, 73, 10.1517/14728222.6.1.73 Klasa, 2002, Oblimersen Bcl-2 antisense: facilitating apoptosis in anticancer treatment, Antisense Nucleic Acid Drug Dev, 12, 193, 10.1089/108729002760220798 Khodadoust, 2001, Bcl-2 Antisense oligodeoxynucleotide (Genasense) enhances gemtuzumab ozogamicin (Mylotarg)-induced cytotoxicity in acute myeloid leukemia, Blood, 98, 102a Sievers, 2001, Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse, J Clin Oncol, 19, 3244, 10.1200/JCO.2001.19.13.3244 Bickel, 1977 Garrido, 2001, Blasts from elderly acute myeloid leukemia patients are characterized by low levels of culture- and drug-induced apoptosis, Leuk Res, 25, 23, 10.1016/S0145-2126(00)00083-7 Vey, 1999, Effect of complete remission on survival in patients with acute myelogenous leukemia receiving first salvage therapy, Blood, 93, 3149, 10.1182/blood.V93.9.3149 Marcucci, 2003, Phase 1 and pharmacodynamic studies of G3139, a Bcl-2 antisense oligonucleotide, in combination with chemotherapy in refractory or relapsed acute leukemia, Blood, 101, 425, 10.1182/blood-2002-06-1899 Marcucci, 2003, Pharmacologic and biologic assessment of Genasense (GNS, oblimersen sodium), a pro-apoptotic to Bcl-2 oligonucleotide, in combination with daunorubicin and cytarabine: a Phase I study in previously untreated elderly acute myeloid leukemia (AML), Blood, 102, 874a Marcucci, 2005, 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, 23, 3404, 10.1200/JCO.2005.09.118 Kirkwood, 2005, Long-term survival results of a randomized multinational Phase 3 trial of dacarbazine (DTIC) with or without Bcl-2 antisense (oblimersen sodium) in patients (pts) with advanced malignant melanoma (MM), J Clin Oncol, 23, 711s, 10.1200/jco.2005.23.16_suppl.7506 Rai, 2004, Phase 3 randomized trial of fludarabine/cyclophosphamide chemotherapy with or without oblimersen sodium (Bcl-2 antisense; genasense; G3139) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), Blood, 104, 100a, 10.1182/blood.V104.11.338.338 Leith, 1997, Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A southwest oncology group study, Blood, 89, 3323, 10.1182/blood.V89.9.3323