A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: A trial by the Eastern Cooperative Oncology Group

Blood

Volumn 103, Issue 2, 2004, Pages 479-485

  Rowe, Jacob M ^a   Neuberg, Donna ^b   Friedenberg, William ^b   Bennett, John M ^b   Paietta, Elisabeth ^b   Makary, Adel Z ^b   Liesveld, Jane L ^b   Abboud, Camille N ^b   Dewald, Gordon ^b   Hayes, F Ann ^b   Tallman, Martin S ^b   Wiernik, Peter H ^b  

^a RAMBAM MEDICAL CENTER   (Israel)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CYTARABINE; DAUNORUBICIN; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HEMOPOIETIC GROWTH FACTOR; IDARUBICIN; MITOXANTRONE;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ARTICLE; BONE MARROW APLASIA; CANCER REGRESSION; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOMES RESEARCH; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE;

EID: 9144238671     PISSN: 00064971     EISSN: None     Source Type: Journal    
DOI: 10.1182/blood-2003-05-1686     Document Type: Article

References (44)

1. Coltman CH, Freireich EJ, Pendleton O, et al. Adult acute leukemia studies using cytarabine: early South-West Oncology Group trial. Med Pediat Oncol. 1982;10:173-183.
2. Yates J, Glidewell OJ, Wiernik P, et al. Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study. Blood. 1982;60:454-462.
3. Rai KR, Holland JF, Glidewell OJ, et al. Treatment of acute myelocytic leukemia: a study by Cancer and Leukemia Group B. Blood. 1981;58:1203-1212.
4. Dillman RO, Davis RB, Green MR, et al. A comparative study of two different doses of cytarabine for acute myeloid leukemia: a phase III trial of Cancer and Leukemia Group B. Blood. 1991;78:2520-2526.
5. Preisler HD, Davis RB, Kirshner J, et al. Comparison of three remission induction regimens and two postinduction strategies for the treatment of acute non-lymphocytic leukemia: a Cancer Leukemia Group B study. Blood. 1987;69:1441-1449.
6. Berman E, Heller J, Santorsa J, et al. Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood. 1991;77:1666-1674.
7. Vogler WR, Velez-Garcia E, Weiner RS, et al. A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a South Eastern Cancer Study Group. J Clin Oncol. 1992;10:1103-1111.
8. Wiernik PH, Banks PL, Case DC, et al. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992;79:313-319.
9. Mandelli F, Petti MC, Ardia A, et al. A randomised clinical trial comparing idarubicin and cytarabine to daunorubicin and cytarabine in the treatment of acute non-lymphoid leukaemia: a multicentric study from the Italian Co-operative Group GIMEMA. Eur J Cancer. 1991;27:750-755.
10. Berman E, Arlin ZA, Gaynor J, et al. Comparative trial of cytarabine and thioguanine in combination with amsacrine or daunorubicin in patients with untreated acute nonlymphoid leukemia: results of the L-16M protocol. Leukemia. 1999;3:115-121.
11. Keating MJ, Gehan EA, Smith TL, et al. A strategy for evaluation of new treatment in untreated patients: application to a clinical trial of AMSA for acute leukemia. J Clin Oncol. 1987;5:710-721.
12. Hansen OP, Pedersen-Bjergaard J, Ellegaard J, et al. Aclarubicin plus cytosine arabinoside versus daunorubicin plus cytosine arabinoside in previously untreated patients with acute myeloid leukemia: a Danish National phase III trial. The Danish Society of Hematology Study Group Leukemia on AML, Denmark. Leukemia. 1991;5:510-516.
13. Arlin ZA, Case DC, Moore J, et al. Randomized multicenter trial of cytosine arabinoside with mitoxantrone or daunorubicin in previously untreated patients with acute nonlymphocytic leukemia (ANLL). Lederle Cooperative Group. Leukemia. 1990;4:177-183.
14. Pavlovsky S, Gonzles Llaven J, Carcia Martinez MA, et al. A randomized study of mitoxantrone plus cytarabine versus daunomycin plus cytarabine in the treatment of previously untreated adult patients with acute nonlymphocytic leukemia. Ann Hematol. 1994;69:11-15.
15. AML Collaborative Group. A systematic collaborative overview of randomized trials comparing idarubicin with daunorubicin (or other anthracyclines) as induction therapy for acute myeloid leukaemia. Br J Haematol. 1998;103:100-109.
16. Aglietta M, Piacibello W, Pasquino P, et al. Rationale for the use of granulocyte-macrophage colony-stimulating factor in oncology. Semin Oncol. 1994;21:5-9.
17. Rowe JM, Andersen JW, Mazza JJ, et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55-70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86:457-462.
18. Liesveld JL, Harbol AW, Abboud CN. A stem cell factor and stromal cell co-culture prevent apoptosis in a subculture of the megakaryoblastic cell line, UT-7. Leuk Res. 1996;20:591-600.
19. Slovick FT, Abboud CN, Brennan JK, Lichtman MA. Survival of granulocytic progenitors in the adherent and non-adherent compartments of human long-term marrow cultures. Exp Hematol. 1984;12:327-338.
20. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
21. Hollander M, Wolfe DA. Nonparametric statistical methods. New York, NY: Wiley & Sons; 1973.
22. Slovak ML, Kopecky KJ, Cassileth PA, et al. Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group Study. Blood. 2000;96:4075-4083.
23. Leith CP, Kopecky KJ, Godwin J, et al. Acute myeloid leukemia in the elderly: Assessment of multidrug resistance (MDR 1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy: a South-West Oncology Group study. Blood. 1997;89:3323-3329.
24. Rowe JM. Treatment of acute myelogenous leukemia in older adults. Leukemia. 2000;14:480-487.
25. Goldstone AH, Burnett AK, Wheatley K, et al. Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: the results of the United Kingdom Medical Research Council AML 11 trial. Blood. 2001;98:1302-1311.
26. Anderson JE, Kopecky KJ, Willman CL, et al. Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study. Blood. 2002;100:3869-3876.
27. Reuter C, Auf der Landwehr U, Schleyer U, et al. Modulation of intracellular metabolism in cytosine arabinoside in acute myeloid leukemia by granulocyte-macrophage colony-stimulating factor. Leukemia. 1994;8:217-225.
28. McCulloch EA, Hedley DW, Minden MD. Response of AML blasts to Ara-C: role of bcl-2 in the regulation of sensitivity [abstract]. Ann Hematol. 1997;78(suppl. 1):12a.
29. Bhalla K, Holladay C, Arlin Z, Grant S, Ibrado AM, Jasiok M. Treatment with IL-3 plus GM-CSF improves the selectivity of A-C in vitro against AML blasts. Blood. 1990;78:2674-2679.
30. Cannistra SA, Di Carlo J, Groshek P, et al. Simultaneous administration of granulocyte-macrophage colony-stimulating factor and cytosine arabinoside for the treatment of relapsed acute myeloid leukemia. Leukemia. 1991;5:230-238.
31. Bettelheim P, Valent P, Andreeff M, et al. Recombinant human granulocyte-macrophage colony-stimulating factor in combination with standard induction therapy in de novo acute myeloid leukemia. Blood. 1991;77:700-711.
32. Büchner T, Hiddemann W, Wörmann B, et al. Hematopoietic growth factors in acute myeloid leukemia: supportive and priming effects. Semin Oncol. 1997;24:124-131.
33. Ohno R, Naoe T, Kanamaru A, Yoshida M, Hiraoka A, Kobayashi T. A double-blind controlled study of granulocyte colony-stimulating factor started two days before induction chemotherapy in refractory acute myeloid leukemia. Kohseisho Leukemia Study Group. Blood. 1994;83:2086-2092.
34. Estey E, Thall P, Andreeff M, et al. Use of granulocyte colony-stimulating factor before, during and after fludarabine plus cytarabine induction therapy of newly diagnosed acute myelogenous leukemia or myelodysplastic syndromes: comparison with fludarabine plus cytarabine without granulocyte colony-stimulating factor. J Clin Oncol. 1994;12:671-678.
35. Estey E, Thall PF, Kantarjian H, et al. Treatment of newly diagnosed acute myelogenous leukemia with granulocyte-macrophage colony-stimulating factor (GM-CSF) before and during continuous-infusion high-dose Ara-C + daunorubicin: comparison to patients treated without GM-CSF. Blood. 1992;79:2246-2255.
36. Zittoun R, Suciu S, Mandelli F, et al. Granulocyte-macrophage colony-stimulating factor associated with induction treatment of acute myelogenous leukemia: a randomized trial by the European Organization for Research and Treatment of Cancer and Leukemia Cooperative Group. J Clin Oncol. 1996;14:2150-2159.
37. Heil G, Hoelzer D, Sanz MA, et al. The randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia. The International Acute Myeloid Leukemia Study Group. Blood. 1997;90:4710-4718.
38. Witz F, Sadoun A, Perrin MC, et al. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction therapy for de novo acute myelogenous leukemia in elderly patients. Group Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1998;91:2722-2730.
39. Peterson B, George K, Bhalla K, Schiffer C, A phase III trial with or without GM-CSF administered before and during high dose cytarabine in patients with relapsed or refractory acute myelogenous leukemia (CALGB 9021) [abstract]. Proc Am Soc Clin Oncol. 1996;15:3a.
40. Löwenberg B, Suciu S, Archimbaud E, et al. Use of recombinant GM-CSF during and after remission induction chemotherapy in patients aged 61 years and older with acute myeloid leukemia: final report of AML-11, a phase III randomized study of the Leukemia Cooperative Group of European Organisation for the Research and Treatment of Cancer and the Dutch Belgian Hemato-Oncology Cooperative Group. Blood. 1997;90:2952-2961.
41. Thomas X, Fenaux P, Dombret H, et al. Granulocyte-macrophage colony-stimulating factor (GM-CSF) to increase efficacy of intensive sequential chemotherapy with etoposide, mitoxantrone and cytarabine (EMA) in previously treated acute myeloid leukemia: a multicenter randomized placebo-controlled trial (EMA 91 trial). Leukemia. 1999;13:1214-1220.
42. Rowe JM. Concurrent use of growth factors in chemotherapy in acute leukemia. Curr Opin Hematol. 2000;7:197-202.
43. Grimwade D, Walker H, Oliver F, et al. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1612 patients entered in to the MRC AML 10 trial. Blood. 1998;92:2322-2333.
44. Grimwade D, Walker H, Harrison G, et al. The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): analysis of 1065 patients entered into the United Kingdom Medical Research Council AML 11 trial. Blood. 2001;98:1312-1320.