Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia

Leukemia Research

Volumn 27, Issue 10, 2003, Pages 887-891

  Apostolidou, Efrosyni ^a   Cortes, Jorge ^a   Tsimberidou, Apostolia ^a   Estey, Elihu ^a   Kantarjian, Hagop ^a   Giles, Francis J ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Acute myeloid leukemia; Cyclosporine A; Cytarabine; DaunoXome; Gemtuzumab ozogamicin; MDR; Multi drug resistance; Refractory

Indexed keywords

ANTHRACYCLINE ANTIBIOTIC AGENT; ANTHRAQUINONE; CYCLOSPORIN A; CYTARABINE; DAUNORUBICIN; GEMTUZUMAB OZOGAMICIN; IDARUBICIN; LIPOSOME; PROTEIN;

ACUTE GRANULOCYTIC LEUKEMIA; ADOLESCENT; ADULT; AGED; ARTICLE; ASCITES; CANCER PATIENT; CANCER RECURRENCE; CANCER REGRESSION; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG ACTIVITY; ENCAPSULATION; FEMALE; FLUID RETENTION; GASTROINTESTINAL HEMORRHAGE; HAND FOOT SYNDROME; HEPATOMEGALY; HUMAN; HYPERBILIRUBINEMIA; INFECTION; LIVER TOXICITY; MALE; MUCOSA INFLAMMATION; MULTIDRUG RESISTANCE; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; NONHEMATOLOGIC TOXICITY; PILOT STUDY; PRIORITY JOURNAL; PROTEIN EXPRESSION; REFRACTORY PERIOD; SEPSIS; SIDE EFFECT; SYNDROME; THROMBOCYTE; THROMBOCYTOPENIA; TOXICITY; TRANSAMINITIS; TREMOR; VOMITING; WEIGHT GAIN;

EID: 0038015273     PISSN: 01452126     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0145-2126(03)00021-3     Document Type: Article

References (32)

1. Giles F, Garcia-Manero G, O'Brien S, et al. Fatal hepatic venoocclusive disease on a phase I study of Mylotarg and Troxatyl in patients with refractory acute myeloid leukemia or myelodysplastic syndrome. J Hematol 2002;108:164-7.
2. Bernstein I.D. Monoclonal antibodies to the myeloid stem cells: therapeutic implications of CMA-676, a humanized anti-CD33 antibody calicheamicin conjugate. Leukemia. 14:2000;474-475.
3. Marosi C., Koller U., Koller-Weber E.et al. Prognostic impact of karyotype and immunologic phenotype in 125 adult patients with de novo AML. Cancer Genet. Cytogenet. 61:1992;14-25.
4. Sievers E.L., Larson R.A., Stadtmauer E.A.et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J. Clin. Oncol. 19:2001;3244-3254.
5. Estey E.H., Thall P.F., Giles F.J.et al. 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. 99:2002;4343-4349.
6. Linenberger M.L., Hong T., Flowers D.et al. Multidrug-resistance phenotype and clinical responses to gemtuzumab ozogamicin. Blood. 98:2001;988-994.
7. List A.F., Kopecky K.J., Willman C.L. Benefit of cyclosporine modulation of drug resistance in patients with poor-risk acute myeloid leukemia: a Southwest Oncology Group study. Blood. 98:2001;3212-3220.
8. Michieli M., Damiani D., Ermacora A.et al. Liposome-encapsulated daunorubicin doubles anthracycline toxicity in cell lines showing a non-PGP related multi-drug resistance. Haematologica. 84:1999;1151-1152.
9. Wang Y., Eksborg S., Lewensohn R.et al. In vitro cellular accumulation and cytotoxicity of liposomal and conventional formulations of daunorubicin and doxorubicin in resistant K562 cells. Anticancer Drugs. 10:1999;921-928.
10. Cortes J., O'Brien S., Estey E.et al. Phase I study of liposomal daunorubicin in patients with acute leukemia. Invest. New Drugs. 17:1999;81-87.
11. Cortes J., Estey E., O'Brien S.et al. High-dose liposomal daunorubicin and high-dose cytarabine combination in patients with refractory or relapsed acute myelogenous leukemia. Cancer. 92:2001;7-14.
12. Bearman S.I. Venoocclusive disease of the liver. Curr. Opin. Oncol. 12:2000;103-109.
13. Bennett J.M., Catovsky D., Daniel M.T.et al. Proposals for the classification of the acute leukaemias. French-American-British (FAB) co-operative group. Br. J. Haematol. 33:1976;451-458.
14. Giles F.J., Kantarjian H.M., Kornblau S.M.et al. Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer. 92:2001;406-413.
15. Bernstein I.D. CD33 as a target for selective ablation of acute myeloid leukemia. Clin. Lymph. 2(Suppl. 1):2002;S9-S11.
16. Bross P.F., Beitz J., Chen G.et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin. Cancer Res. 7:2001;1490-1496.
17. Amadori S., Willemze R., Suciu S.et al. Sequential administration of gemtuzumab ozogamicin and intensive chemotherapy for remission induction in previously untreated patients with AML over the age of 60: interim results of the EORTC leukemia group AML-A phase II trial [abstract]. Blood. 98:2001;587a.
18. DeAngelo D., Russo D., Castaigne S.et al. Preliminary report of the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) given in combination with cytarabine and daunorubicin in patients with acute myeloid leukemia [abstract]. Blood. 98:2001;199b.
19. Kell J.W., Burnett A.K., Chopra R.et al. Effects of Mylotarg (gemtuzumab ozogomycin) in combination with standard induction chemotherapy in the treatment of acute myeloid leukaemia: a feasibility study [abstract]. Blood. 98:2001;123a.
20. Langston A., Fienstein B., Hutcherson D.et al. Non-natal venoocclusive disease in non-transplant patients after treatment of relapsed AML with Mylotarg (gemtuzumab ozogamicin) [abstract]. Blood. 98:2001;201b.
21. Estey E.H., Giles F.J., Beran M.et al. Experience with gemtuzumab ozogamycin ("Mylotarg") and all-trans retinoic acid in untreated acute promyelocytic leukemia. Blood. 99:2002;4222-4224.
22. Beran M., Shen Y., Kantarjian H.et al. High-dose chemotherapy in high-risk myelodysplastic syndrome: covariate-adjusted comparison of five regimens. Cancer. 92:2001;1999-2015.
23. Estey E.H., Thall P.F., Cortes J.E.et al. Comparison of idarubicin + ara-C-, fludarabine + ara-C-, and topotecan + ara-C-based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts. Blood. 98:2001;3575-3583.
24. Giles F., Garcia-Manero G., Cortes J. Ursodiol does not prevent hepatic venoocclusive disease associated with Mylotarg therapy. Haematologica. 87:2002;1114-11166.
25. McDonald G.B. Management of hepatic sinusoidal obstruction syndrome following treatment with gemtuzumab ozogamicin (Mylotarg). Clin. Lymph. 2(Suppl. 1):2002;S35-S39.
26. Sievers E.L., Larson R.A., Estey E.et al. Low incidence of hepatic venoocclusive disease after treatment with gemtuzumab ozogamicin (Mylotarg, CMA-676): relationship to hematopoietic stem cell transplantation [abstract]. Blood. 96:2000;206b.
27. Tsimberidou A, Estey E, Cortes J, et al. Mylotarg, fludarabine, cytarabine (ara-C) and cyclosporine (MFAC) in patients with newly diagnosed acute myelogenous leukemia or high-risk myelodysplastic syndromes. Cancer [in press].
28. Forssen E.A., Male-Brune R., Adler-Moore J.P.et al. Fluorescence imaging studies for the disposition of daunorubicin liposomes (DaunoXome) within tumor tissue. Cancer Res. 56:1996;2066-2075.
29. Fassas A., Buffels R., Anagnostopoulos A.et al. Safety and early efficacy assessment of liposomal daunombicin (DaunoXome) in adults with refractory or relapsed acute myeloblastic leukaemia: a phase I-II study. Br. J. Haematol. 116:2002;308-315.
30. Pouna P., Bonoron-Adele S., Gouverneur G.et al. Development of the model of rat isolated perfused heart for the evaluation of anthracycline cardiotoxicity and its circumvention. Br. J. Pharmacol. 117:1996;1593-1599.
31. Guaglianone P., Chan K., DelaFlor-Weiss E.et al. Phase I and pharmacologic study of liposomal daunorubicin (DaunoXome). Invest. New Drugs. 12:1994;103-110.
32. Hui Y.F., Cortes J.E. Palmar-plantar erythrodysesthesia syndrome associated with liposomal daunombicin. Pharmacotherapy. 20:2000;1221-1223.