Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia : final results of AML-13, a randomized phase-3 study
Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia : final results of AML-13, a randomized phase-3 study
Publication date :
2005
Journal title :
Blood
ISSN :
0006-4971
eISSN :
1528-0020
Publisher :
American Society of Hematology, Washington, United States - District of Columbia
Stone RM. The difficult problem of acute myeloid leukemia in the older adult. CA Cancer J Clin. 2002;52:363-371.
Stasi R, Venditti A, Del Poeta G, et al. Intensive treatment of patients age 60 years and older with de novo acute myeloid leukemia: analysis of prognostic factors. Cancer. 1996;77:2476-2488.
Leith CP, Kopecky KJ, Godwin J, et al. 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. 1997;89:3323-3329.
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 AML11 trial. Blood. 2001;98:1312-1320.
Hiddemann W, Kern W, Schoch C, et al. Management of acute myeloid leukemia in elderly patients. J Clin Oncol. 1999;17:3569-3576.
Stone RM, Berg DT, George SL, et al. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia: Cancer and Leukemia Group B. N Engl J Med. 1995;332:1671-1677.
Dombret H, Chastang C, Fenaux P, et al. A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia: AML Cooperative Study Group. N Engl J Med. 1995;332:1678-1683.
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 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86:457-462.
Heil G, Hoelzer D, Sanz MA, et al. A 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.
Godwin JE, Kopecky KJ, Head DR, et al. A double-blind placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: a Southwest Oncology Group study (9031). Blood. 1998;91:3607-3615.
Goldstone AH, Burnett AK, Wheatley K, Smith AG, Hutchinson RM, Clark RE. Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: the results of the United Kingdom Medical Research Council AML11 trial. Blood. 2001;98:1302-1311.
Schiffer CA. Hematopoietic growth factors and the future of therapeutic research on acute myeloid leukemia. N Engl J Med. 2003;349:727-729.
Ohno R, Naoe T, Kanamaru A, et al. 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.
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.
Heil G, Chadid L, Hoelzer D, et al. GM-CSF in a double-blind randomized, placebo controlled trial in therapy of adult patients with de novo acute myeloid leukemia (AML). Leukemia. 1995;9:3-9.
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 Leukemia Cooperative Group. J Clin Oncol. 1996;14:2150-2159.
Lowenberg 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 Hematc-Oncology Cooperative Group. Blood. 1997;90:2952-2961.
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 treatment for de novo acute myelogenous leukemia in elderly patients: Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1998;91:2722-2730.
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 (EMA91 Trial). Leukemia. 1999;13:1214-1220.
Lowenberg B, van Putten W, Theobald M, et al. Effect of priming with granulocyte colony-stimulating factor on the outcome of chemotherapy for acute myeloid leukemia. N Engl J Med. 2003;349:743-752.
Rowe JM, Neuberg D, Friedenberg W, et al. 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. 2004;103:479-485.
Löfgren C, Paul C, Astrom M, et al. Granulocyte-macrophage colony-stimulating factor to increase efficacy of mitoxantrone, etoposide and cytarabine in previously untreated elderly patients with acute myeloid leukaemia: a Swedish multicentre randomized trial. Br J Haematol. 2004;124:474-480.
Yates J, Glidewell O, Wiernik P, et al. Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study. Blood. 1982;60:454-462.
Bennett JM, Catovsky D, Daniel MT, et al. Proposed revised criteria for the classification of acute myeloid leukemia: a report of the French-American-British Cooperative Group. Ann Intern Med. 1985;103:620-625.
Bennett JM, Catovsky D, Daniel MT, et al. Proposal for the recognition of minimally differentiated acute myeloid leukaemia (AML-MO). Br J Haematol. 1991;78:325-329.
Freedman LS. Tables of the number of patients required in clinical trials using the logranktest. Stat Med. 1982;1:121-129.
Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. 2nd ed. Hoboken, NJ: John Wiley & Sons: 2002.
Slud EV, Byar DP, Green SB. A comparison of reflected vs test-based confidence intervals for the median survival time, based on censored data. Biometrics. 1984;40:587-600.
Agresti A. An Introduction to Categorical Data Analysis. New York, NY: John Wiley & Sons; 1996.
Miyauchi J, Kelleher CA, Wang C, Minkin S, McCulloch EA. Growth factors influence the sensitivity of leukemic stem cells to cytosine arabinoside in culture. Blood. 1989;73:1272-1278.
Bhalla K, Holladay C, Arlin Z, Grant S, Ibrado AM, Jasiok M. Treatment with interleukin-3 plus granulocyte-macrophage colony-stimulating factors improves the selectivity of Ara-C in vitro against acute myeloid leukemia blasts. Blood. 1991;78:2674-2679.
te Boekhorst PA, Lowenberg B, Vlastuin M, Sonneveld P. Enhanced chemosensitivity of clonogenic blasts from patients with acute myeloid leukemia by G-CSF, IL-3 or GM-CSF stimulation. Leukemia. 1993;7:1191-1198.
Reuter C, Auf der Landwehr U, Schleyer E, et al. Modulation of intracellular metabolism of cytosine arabinoside in acute myeloid leukemia by granulocyte-macrophage colony-stimulating factor. Leukemia. 1994;8:217-225.
te Boekhorst PA, Lowenberg B, Sonneveld P. Hematopoietic growth factor stimulation and cytarabine cytotoxicity in vitro: effects in untreated and relapsed or primary refractory acute myeloid leukemia cells. Leukemia. 1994;8:1480-1486.
Munck JN, Deacaudin D, Koscielny S. Recombinant granulocyte colony-stimulating factor in acute myelogenous leukemia. N Engl J Med. 1995;333:1155-1156.
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.
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;15:3.
Rowe JM. Concurrent use of growth factors and chemotherapy in acute leukemia. Curr Opin Hematol. 2000;7:197-202.
Buchner T, Berdel WE, Hiddemann W. Priming with granulocyte colony-stimulating factor-relation to high-dose cytarabine in acute myeloid leukemia. N Engl J Med. 2004;350:2215-2216.
Bennett CL, Stinson TJ, Tallman MS, et al. Economic analysis of a randomized placebo-controlled phase III study of granulocyte macrophage colony stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: Eastern Cooperative Oncology Group (E1490). Ann Oncol. 1999;10:177-182.
Bennett CL, Hynes D, Godwin J, Stinson TJ, Golub RM, Appelbaum FR. Economic analysis of granulocyte colony stimulating factor as adjunct therapy for older patients with acute myelogenous leukemia (AML): estimates from a Southwest Oncology Group clinical trial. Cancer Invest. 2001;19:603-610.
Bennett CL, Schumock GT. Cost analyses of adjunct colony stimulating factors for older patients with acute myeloid leukaemia: can they improve clinical decision making? Drugs Aging. 2003;20:479-483.