The role of Gemtuzumab Ozogamicin in the treatment of acute myeloid leukemia patients

Oncogene

Volumn 26, Issue 25, 2007, Pages 3679-3690

  Pagano, L ^a   Fianchi, L ^a   Caira, M ^a   Rutella, S ^a   Leone, G ^a  

^a CATHOLIC UNIVERSITY   (Italy)

Author keywords

Acute myeloid leukemia; Elderly; Mylotarg

Indexed keywords

AMIFOSTINE; CYCLOSPORIN; CYTARABINE; DAUNORUBICIN; ETOPOSIDE; FLUDARABINE; GEMTUZUMAB OZOGAMICIN; IDARUBICIN; INTERLEUKIN 11; MITOXANTRONE; OBLIMERSEN; TIOGUANINE; TOPOTECAN;

ACUTE GRANULOCYTIC LEUKEMIA; APOPTOSIS; BONE MARROW SUPPRESSION; BRAIN HEMORRHAGE; CANCER COMBINATION CHEMOTHERAPY; CHILL; CLINICAL TRIAL; DRUG APPROVAL; DRUG DOSE ESCALATION; DRUG FEVER; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG TOLERABILITY; DYSPNEA; EUROPE; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPOTENSION; IN VITRO STUDY; INFECTION COMPLICATION; LIVER TOXICITY; LIVER VEIN OBSTRUCTION; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE ORGAN FAILURE; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; RASH; REVIEW; SEPSIS; SIDE EFFECT; SINGLE DRUG DOSE; THROMBOCYTOPENIA; UNITED STATES; VOMITING;

AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; HEMATOLOGIC TESTS; HUMANS; IMMUNOTHERAPY; LEUKEMIA, MYELOCYTIC, ACUTE; SENSITIVITY AND SPECIFICITY;

MURINAE;

EID: 34249654627     PISSN: 09509232     EISSN: 14765594     Source Type: Journal    
DOI: 10.1038/sj.onc.1210364     Document Type: Review

References (71)

1. Alvarado Y, Tsimberidou A, Kantarjian H, Cortes J, Garcia-Manero G, Faderl S et al. (2003). Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia. Cancer Chemother Pharmacol 51: 87-90.
2. Amadori S, Suciu S, Stasi R, Willemze R, Mandelli F, Selleslag D et al. (2005). Gemtuzumab ozogamicin (Mylotarg) as singleagent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups. Leukemia 19: 1768-1773.
3. Amadori S, Suciu S, Willemze R, Mandelli F, Selleslag D, Stauder R et al. (2004). Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups. Haematologica 89: 950-956.
4. Amico D, Barbui AM, Erba E, Rambaldi A, Introna M, Golay J. (2003). Differential response of human acute myeloid leukemia cells to gemtuzumab ozogamicin in vitro: role of Chk1 and Chk2 phosphorylation and caspase 3. Blood 101: 4589-4597.
5. Apostolidou E, Cortes J, Tsimberidou A, Estey E, Kantarjian H, Giles FJ. (2003). Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia. Leuk Res 27: 887-891.
6. Arceci RJ, Sande J, Lange B, Shannon K, Franklin J, Hutchinson R et al. (2005). Safety and efficacy of gemtuzumab ozogamicin in pediatric patients with advanced CD33+ acute myeloid leukemia. Blood 106: 1183-1188.
7. Balailan L, Zhong RK, Ball ED. (2003). The inhibitory effect of anti-CD33 monoclonal antibodies on AML cell growth correlates with Syk and/or ZAP-70 expression. Exp Hematol 31: 363-371.
8. Bearman SI. (2000). Veno-occlusive disease of the liver. Curr Opin Oncol 12: 103-109.
9. Chevallier P, Roland V, Mahe B, Juge-Morineau N, Dubruille V, Guillaume T et al. (2005). Administration of mylotarg 4 days after beginning of a chemotherapy including intermediate-dose aracytin and mitoxantrone (MIDAM regimen) produces a high rate of complete hematologic remission in patients with CD33+ primary resistant or relapsed acute myeloid leukemia. Leuk Res 29: 1003-1007.
10. Cohen AD, Luger SM, Sickles C, Mangan PA, Porter DL, Schuster SJ et al. (2002). Gemtuzumab ozogamicin (Mylotarg) monotherapy for relapsed AML after hematopoietic stem cell transplant: efficacy and incidence of hepatic venoocclusive disease. Bone Marrow Transplant 30: 23-28.
11. Cortes J, Tsimberidou AM, Alvarez R, Thomas D, Beran M, Kantarjian H et al. (2002). Mylotarg combined with topotecan and cytarabine in patients with refractory acute myelogenous leukemia. Cancer Chemother Pharmacol 50: 497-500.
12. Crocker PR. (2002). Siglecs: sialic-acid-binding immunoglobulinlike lectins in cell-cell interactions and signalling. Curr Opin Struct Biol 12: 609-615.
13. De Angelo DJ, Stone RM, Durrant S, Liu D, Baccarani M, Schiffer CA et al. (2003). Gemtuzumab Ozogamicin (Mylotargs®) in combination with induction chemotherapy for the treatment of patients with de novo acute myeloid leukemia: two age-specific phase 2 trials. Blood 102: Abstr. 341.
14. Dinndorf PA, Andrews RG, Benjamin D, Ridgway D, Wolff L, Bernstein ID. (1986). Expression of normal myeloidassociated antigens by acute leukemia cells. Blood 67: 1048-1053.
15. Estey EH. (2000). Treatment of relapsed and refractory acute myelogenous leukemia. Leukemia 14: 447-476.
16. Estey EH, Giles FJ, Beran M, O'Brien S, Pierce SA, Faderl SH et al. (2002a). Experience with gemtuzumab ozogamycin ('mylotarg') and all-trans retinoic acid in untreated acute promyelocytic leukemia. Blood 99: 4222-4224.
17. Estey EH, Thall PF, Giles FJ, Wang XM, Cortes JE, Beran M et al. (2002b). Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside. Blood 99: 4343-4349.
18. Fianchi L, Leoni F, Storti S, Rutella S, Voso MT, Scardocci A et al. (2006). Gentuzumab-Ozogamicin, Citosine Arabinoside, G-CSF combination (G-Ara-My) in the treatment of elderly poor prognosis acute myeloid leukemia. A multicentric study. Haematol Rep 2: 83a.
19. Giles FJ, Kantarjian HM, Kornblau SM, Thomas DA, Garcia-Manero G, Waddelow TA et al. (2001). Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer 2: 406-413.
20. Guglielmi C, Martelli MP, Diverio D, Fenu S, Vegna ML, Cantu-Rajnoldi A et al. (1998). Immunophenotype of adult and childhood acute promyelocytic leukaemia: correlation with morphology, type of PML gene breakpoint and clinical outcome. A cooperative Italian study on 196 cases. Br J Haematol 102: 1035-1041.
21. Ikemoto N, Kumar RA, Ling TT, Ellestad GA, Danishefsky SJ, Patel DJ. (1995). Calicheamicin-DNA complexes: warhead alignment and saccharide recognition of the minor groove. Proc Natl Acad Sci USA 92: 10506-10510.
22. Jedema I, Barge RM, van der Velden VH, Nijmeijer BA, van Dongen JJ, Willemze R et al. (2004). Internalization and cell cycle-dependent killing of leukemic cells by Gemtuzumab Ozogamicin: rationale for efficacy in CD33-negative malignancies with endocytic capacity. Leukemia 18: 316-325.
23. Jurcic JG, Deblasio T, Dumont L, Yao TJ, Scheinberg DA. (2000). Molecular remission induction with retinoic acid and anti-CD33 monoclonal antibody HuM 195 in acute promyelocytic leukemia. Clin Cancer Res 6: 372-380.
24. Keating MJ, Kantarjian H, Smith TL, Estey E, Walters R, Andersson B et al. (1989). Response to salvage therapy and survival after relapse in acute myelogenous leukemia. J Clin Oncol 7: 1071-1080.
25. Kell WJ, Burnett AK, Chopra R, Yin JA, Clark RE, Rohatiner A et al. (2003). A feasibility study of simultaneous administration of gemtuzumab ozogamicin with intensive chemotherapy in induction and consolidation in younger patients with acute myeloid leukemia. Blood 102: 4277-4283.
26. Langston AA, McMillan S, Lonial S, Smith K, Waller EK, Heffner LT et al. (2004). A phase I trial of Ara-C, topotecan, and Gemtuzumab Ozogamicin (Mylotargs®) for advanced MDS and secondary or relapsed AML. Blood 104: Abstr. 1814.
27. Larson RA, Boogaerts M, Estey E, Karanes C, Stadtmauer EA, Sievers EL, et al., Mylotarg Study Group. (20 02). An tibodytargeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin). Leukemia 16: 1627-1636.
28. Larson RA, Sievers EL, Stadtmauer EA, Lowenberg B, Estey EH, Dombret H et al. (2005). Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence. Cancer 104: 1442-1452.
29. Legrand O, Perrot JY, Baudard M, Cordier A, Lautier R, Simonin G et al. (2000). The immunophenotype of 177 adults with acute myeloid leukemia: proposal of a prognostic score. Blood 96: 870-877.
30. Leone G, Rutella S, Voso MT, Fianchi L, Scardocci A, Pagano L. (2004). In vivo priming with granulocyte colonystimulating factor possibly enhances the effect of gemtuzumab-ozogamicin in acute myeloid leukemia: results of a pilot study. Haematologica 89: 634-636.
31. Leopold LH, Berger MS, Cheng SC, Cortes-Franco JE, Giles FJ, Estey EH. (2003). Comparative efficacy and safety of gemtuzumab ozogamicin monotherapy and high-dose cytarabine combination therapy in patients with acute myeloid leukemia in first relapse. Clin Adv Hematol Oncol 1: 220-225.
32. Lo-Coco F, Cimino G, Breccia M, Noguera NI, Diverio D, Finolezzi E et al. (2004). Gemtuzumab ozogamicin (Mylotarg) as a single agent for molecularly relapsed acute promyelocytic leukemia. Blood 104: 1995-1999.
33. McKoy JM, Angelotta C, Bennett CL, Tallman MS, Wadleigh M, Evens AM et al. (2006). Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project. Leuk Res [E-pub ahead of print].
34. Mingari MC, Vitale C, Romagnani C, Falco M, Moretta L. (2001). p75/AIRM1 and CD33, two sialoadhesin receptors that regulate the proliferation or the survival of normal and leukemic myeloid cells. Immunol Rev 181: 260-268.
35. Montillo M, Mirto S, Petti MC, Latagliata R, Magrin S, Pinto A et al. (1998). Fludarabine, cytarabine, and G-CSF (FLAG) for the treatment of poor risk acute myeloid leukemia. Am J Hematol 58: 105-109.
36. Moore J, Seiter K, Kolitz J, Stock W, Giles F, Kalaycio M et al. (2006). A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse. Leuk Res 30: 777-783.
37. Nabhan C, Rundhaugen L, Jatoi M, Riley MB, Boehlke L, Peterson LC et al. (2004). Gemtuzumab ozogamicin (MylotargTM) is infrequently associated with sinusoidal obstructive syndrome/veno-occlusive disease. Ann Oncol 15: 1231-1236.
38. Nabhan C, Rundhaugen LM, Riley MB, Rademaker A, Boehlke L, Jatoi M et al. (2005). Phase II pilot trial of gemtuzumab ozogamicin (GO) as first line therapy in acute myeloid leukemia patients age 65 or older. Leuk Res 29: 53-57.
39. NCCN (2002). NCCN Practice Guidelines in Oncology: Acute Myelogenous Leukemia. National Comprehensive Cancer Network: Rockledge, PA.
40. O'Donnell MR. (2004). Acute leukemias. In: Pazdur R, Coia LR, Hoskins WJ, Wagman LD (eds). Cancer Management: A Multidisciplinary Approach 8th edn. CMP Healthcare Media, Oncology Publishing Group: Manhasset, NY, pp 747-772.
41. Paietta E. (2003). Expression of cell-surface antigens in acute promyelocytic leukaemia. Best Pract Res Clin Haematol 16: 369-385.
42. Pallis M, Russell N. (2004). Strategies for overcoming p-glycoprotein-mediated drug resistance in acute myeloblastic leukaemia. Leukemia 18: 1927-1930.
43. Petti MC, Pinazzi MB, Diverio D, Romano A, Petrucci MT, De Santis S et al. (2001). Prolonged molecular remission in advanced acute promyelocytic leukaemia after treatment with gemtuzumab ozogamicin (Mylotarg CMA-676). Br J Haematol 115: 63-65.
44. Piccaluga PP, Martinelli G, Rondoni M, Malagola M, Gaitani S, Isidori A et al. (2004a). Gemtuzumab ozogamicin for relapsed and refractory acute myeloid leukemia and myeloid sarcomas. Leuk Lymphoma 45: 1791-1795.
45. Piccaluga PP, Martinelli G, Rondoni M, Malagola M, Gaitani S, Visani G et al. (2004b). First experience with gemtuzumab ozogamicin plus cytarabine as continuous infusion for elderly acute myeloid leukaemia patients. Leuk Res 28: 987-990.
46. Rao AV, Rizzieri DA, Moore OJ, De Castro C, Diehl LF, Abernethy AP et al. (2005). Feasibility study of a dose dense induction regimen of high dose cytarabine (HiDAC) and Gemtuzumab Ozogamicin (MylotargTM) for newly diagnosed elderly patients with acute myeloid leukemia. Blood 106: Abstr. 4610.
47. Raza A, Fenaux P, Erba H, Mandelli F, Schiller G, Larson R et al. (2002). Preliminary analysis of a randomized phase 2 study of the safety and efficacy of 1 vs 2 doses of Gemtuzumab Ozogamicin (Mylotargs®) in patients with high risk myelodysplastic syndrome. Blood 100: Abstr. 3140.
48. Reinhardt D, Diekamp S, Fleischhack G, Corbacioglu C, Jurgens H, Dworzak M et al. (2004). Gemtuzumab ozogamicin (Mylotarg) in children with refractory or relapsed acute myeloid leukemia. Onkologie 27: 269-272.
49. Rutella S, Bonanno G, Procoli A, Mariotti A, Lucia MB, Contemi AM et al. (2006). Granulocyte colony-stimulating factor enhances the in vitro cytotoxicity of gemtuzumab ozogamicin against acute myeloid leukemia cell lines and primary blast cells. Exp Hematol 34: 54-65.
50. Rutella S, Pierelli L, Bonanno G, Scambia G, Leone G, Rumi C. (2000). Homogeneous expression of CXC chemokine receptor 4 (CXCR4) on G-CSF-mobilized peripheral blood CD34+ cells. Blood 95: 4015-4016.
51. Schwarz J, Markova J, Pekova S, Trnkova Z, Sponerova D, Cetkovsky P. (2004). A single administration of gemtuzumab ozogamicin for molecular relapse of acute promyelocytic leukemia. Hematol J 5: 279-280.
52. Sievers EL, Appelbaum FR, Spielberger RT, Forman SJ, Flowers D, Smith FO et al. (1999). Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate. Blood 93: 3678-3684.
53. Sievers EL, Appelbaum FR, Spielberger RT, Forman SJ, Flowers D, Smith FO et al. (2000). Antibody-targeted chemotherapy of acute myeloid leukemia using an anti-CD33 calicheamicin immunoconjugate, gemtuzumab ozogamicin. Biol Ther Leuk 1: 4-7.
54. Sievers EL, Larson RA, Stadtmauer EA, Estey E, Lowenberg B, Dombret H et al. (2001). Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 19: 3244-3254.
55. Sivaraman S, Manjali J, Gregory SA, Manson S, Raza A, Venugopal P. (2002). G-CSF and other cytokines modulate expression of CD33 antigen on the surface of myeloid cells. Blood 100: Abstr. 2176.
56. Stone RM, Moser B, Schulman P, Barrier RC, Kolitz JE, Allen SL et al. (2004). A dose escalation and phase II study of Gemtuzumab Ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. Blood 104: Abstr. 873.
57. Takeshita A, Shinjo K, Naito K, Matsui H, Sahara N, Shigeno K et al. (2005). Two patients with all-trans retinoic acid-resistant acute promyelocytic leukemia treated successfully with gemtuzumab ozogamicin as a single agent. Int J Hematol 82: 445-448.
58. Taksin AL, Legrand O, Raffoux E, de Revel T, Thomas X, Contentin N et al. (2007). High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia 21: 66-71.
59. Thalhammer F, Geissler K, Jager U, Kyrle PA, Pabinger I, Mitterbauer M et al. (1996). Duration of second complete remission in patients with acute myeloid leukemia treated with chemotherapy: a retrospective single-center study. Ann Hematol 72: 216-222.
60. Thomas X, Le QH, Tavernier E, Mahmoudi S, Chelghoum Y, Nicolini F et al. (2005). Gemtuzumab Ozogamicin (Mylotargs®) as single agent treatment for adult patients with acute myeloid leukemia (AML). Blood 106: Abstr. 4598.
61. Tsimberidou A, Cortes J, Thomas D, Garcia-Manero G, Verstovsek S, Faderl S et al. (2003a). Gemtuzumab ozogamicin, fludarabine, cytarabine and cyclosporine combination regimen in patients with CD33+ primary resistant or relapsed acute myeloid leukemia. Leuk Res 27: 893-897.
62. Tsimberidou A, Estey E, Cortes J, Thomas D, Faderl S, Verstovsek S et al. (2003b). Gemtuzumab, fludarabine, cytarabine, and cyclosporine in patients with newly diagnosed acute myelogenous leukemia or high-risk myelodysplastic syndromes. Cancer 97: 1481-1487.
63. Tsimberidou AM, Estey E, Whitman GJ, Dryden MJ, Ratnam S, Pierce S et al. (2004). Extramedullary relapse in a patient with acute promyelocytic leukemia: successful treatment with arsenic trioxide, all-trans retinoic acid and gemtuzumab ozogamicin therapies. Leuk Res 28: 991-994.
64. Van der Heiden PL, Jedema I, Willemze R, Barge RM. (2006). Efficacy and toxicity of gemtuzumab ozogamicin in patients with acute myeloid leukemia. Eur J Haematol 76: 409-413.
65. van der Velden VH, te Marvelde JG, Hoogeveen PG, Bernstein ID, Houtsmuller AB, Berger MS et al. (2001). Targeting of the CD33-calicheamicin immunoconjugate Mylotarg (CMA-676) in acute myeloid leukemia: in vivo and in vitro saturation and internalization by leukemic and normal myeloid cells. Blood 97: 3197-3204.
66. Venugopal P, Gregory SA, Raza A, Adler S, Enschede S, Manson SD et al. (2002). Phase II study of Gemtuzumab Ozogamycin (Mylotarg) combined with intensive induction chemotherapy using high dose ara-C and mitoxantrone followed by amifostine in poor prognosis acute myeloid leukemia: preliminary results. Blood 100: Abstr. 1323.
67. Vogler WR, McCarley DL, Stagg M, Bartolucci AA, Moore J, Martelo O et al. (1994). A phase III trial of high-dose cytosine arabinoside with or without etoposide in relapsed and refractory acute myelogenous leukemia. A Southeastern Cancer Study Group trial. Leukemia 8: 1847-1853.
68. Wadleigh M, Richardson PG, Zahrieh D, Lee SJ, Cutler C, Ho V et al. (2003). Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood 102: 1578-1582.
69. Walter RB, Raden BW, Cronk MR, Bernstein ID, Appelbaum FR, Bunker DE. (2004). The peripheral benzodiazepine receptor ligand PK11195 overcomes different resistance mechanisms to sensitize AML cells to gemtuzumab ozogamicin. Blood 103: 4176-4184.
70. Zein N, Poncin M, Nilakantan R, Ellestad GA. (1989). Calicheamicin gamma 1I and DNA: molecular recognition process responsible for site-specificity. Science 244: 697-699.
71. Zwaan CM, Reinhardt D, Corbacioglu S, van Wering ER, Bokkerink JP, Tissing WJ et al. (2003). Gemtuzumab ozogamicin: first clinical experiences in children with relapsed/refractory acute myeloid leukemia treated on compassionate-use basis. Blood 101: 3868-3871.