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

Blood

Volumn 91, Issue 8, 1998, Pages 2722-2730

  Witz, Francis ^a   Sadoun, Alain ^b   Perrin, Marie Claire ^b   Berthou, Christian ^b   Brière, Jean ^b   Cahn, Jean Yves ^b   Lioure, Bruno ^b   Witz, Brigitte ^b   François, Sylvie ^b   Desablens, Bernard ^b   Pignon, Bernard ^b   Le Prisé, Pierre Yves ^b   Audhuy, Bruno ^b   Caillot, Denis ^b   Casassus, Philippe ^b   Delain, Martine ^b   Christian, Bernard ^b   Tellier, Zéra ^b   Polin, Valérie ^b   Hurteloup, Patrick ^b   Harousseau, Jean Luc ^b   more..

^a CHU NANCY BRABOIS   (France)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMSACRINE; ANTINEOPLASTIC AGENT; CYTARABINE; IDARUBICIN; LOMUSTINE; MITOGUAZONE; PLACEBO; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; TIOGUANINE;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ARTICLE; BONE PAIN; CANCER CHEMOTHERAPY; CANCER RECURRENCE; CANCER REGRESSION; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FEVER; FLUSHING; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LIVER TOXICITY; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NEUTROPENIA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

AGE FACTORS; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; INFUSIONS, INTRAVENOUS; LEUKEMIA, MYELOCYTIC, ACUTE; MIDDLE AGED; RECOMBINANT PROTEINS; REMISSION INDUCTION; SURVIVAL ANALYSIS;

EID: 0004313674     PISSN: 00064971     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (45)

1. Brincker H: Estimate of overall treatment results in acute nonlymphocytic leukemia based on age-specific rates of incidence and of complete remission. Cancer Treat Rep 69:5, 1985
2. Groupe Français de Morphologie Hématologique: French registry of acute leukemia and myelodysplastic syndromes: Age distribution and hemogram analysis of the 4496 cases recorded during 1982-1983 and classified according to FAB criteria. Cancer 60:1385, 1987
3. Hamblin TJ: Disappointments in treating acute leukemia in the elderly. N Engl J Med 332:1712, 1995
4. Johnson PRE, Liu Yin JA: Acute myeloid leukemia in the elderly: Biology and treatment. Br J Haematol 83:1, 1993
5. Tucker J, Thomas AE, Gregory WM, Ganesan TS, Malik STA, Amess JAL, Lim J, Willis L, Rohatiner AZS, Lister TA: Acute myeloid leukemia in elderly adults. Hematol Oncol 8:13, 1990
6. Griffin JD, Young D, Herrmann F, Wiper D, Wagner K, Sabbath KD: Effects of recombinant human GM-CSF on proliferation of clonogenic cells in acute myeloblastic leukemia. Blood 67:1448, 1986
7. Bhalla K, Birkhofer M, Arlin Z, Grant S, Lutzky J, Graham G: Effect of recombinant GM-CSF on the metabolism of cytosine arabinoside in normal and leukemic human bone marrow cells. Leukemia 2:810, 1988
8. Cannistra SA, Groshek P, Griffin JD: Granulocyte-macrophage colony-stimulating factor enhances the cytotoxic effects of cytosine arabinoside in acute myeloblastic leukemia and in the myeloid blast crisis phase of chronic myeloid leukemia. Leukemia 3:328, 1989
9. Tafuri A, Andreeff M: Kinetic rationale for cytokine-induced recruitment of myeloblastic leukemia followed by cycle-specific chemotherapy in vitro. Leukemia 4:826, 1990
10. Hiddemann W, Kiehl M, Zühlsdorf M, Busemann C, Schleyer E, Wörmann B, Büchner T: Granulocyte-macrophage colony-stimulating factor and interleukin-3 enhance the incorporation of cytosine arabinoside into the DNA of leukemic blasts and the cytotoxic effect on clonogenic cells from patients with acute myeloid leukemia. Semin Oncol 19:31, 1992
11. Löwenberg B, Touw IP: Hematopoietic growth factors and their receptors in acute leukemia. Blood 81:281, 1993
12. Gore SD, Weng LJ, Burke PJ: Identification of growth factor-responsive acute myelogenous leukemia based on factor-dependence for survival and proliferation. Leukemia 8:1854, 1994
13. Reuter C, Auf der Landwehr U, Schleyer E, Zühlsdorf M, Ameling C, Rolf C, Wörmann B, Büchner T, Hiddemann W: Modulation of intracellular metabolism of cytosine arabinoside in acute myeloid leukemia by granulocyte-macrophage colony-stimulating factor. Leukemia 8:217, 1994
14. Büchner T, Hiddemann W, Koenigsmann M, Zühlsdorf M, Wörmann B, Boeckmann A, Freire EA, Innig G, Mashmeyer G, Ludwig WD, Sauerland MC, Heinecke A, Schulz G: Recombinant human granulocyte-macrophage colony-stimulating factor after chemotherapy in patients with acute myeloid leukemia at higher age or after relapse. Blood 78:1190, 1991
15. OhnoR, Tomonaga M, Kobayashi T, Kanamaru A, Shirakawa S, Masaoka T, Omine M, Oh H, Nomura T, Sakai Y, Hirano M, Yokomaku S, Nakayama S, Yoshida Y, Miura AB, Morishima Y, Dohy H, Niho Y, Hamajina N, Takaku F: Effect of granulocyte colony-stimulating factor after intensive induction therapy in relapsed or refractory acute leukemia. N Engl J Med 323:871, 1990
16. Bennett JM, Catovsky D, Daniel MT, Flandrin G, Gallon DAG, Gralnick HR, Sultan C: Proposed revised criteria for the classification of acute myeloid leukemia: A report of the French-American-British Cooperative Group. Ann Intern Med 103:620, 1985
17. World Health Organization: Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland, WHO, 1979
18. Schiffer CA, Lee EJ, Tomiyasu T, Wiernik PH, Testa JR: Prognostic impact of cytogenetic abnormalities in patients with de novo acute nonlymphocytic leukemia. Blood 73:263, 1989
19. Mrozek K, Heinonen K, de la Chapelle A, Bloomfield CD: Clinical significance of cytogenetics in acute myeloid leukemia. Semin Oncol 24:17, 1997
20. NCI: Common Toxicity Criteria. Bethesda, MD, National Cancer Institute, Division of Cancer Treatment, 1988
21. Geller RB: Use of cytokines in the treatment of acute myelocytic leukemia: A critical revue. J Clin Oncol 14:1371, 1996
22. Dombret H: Granulocytic colony-stimulating factors in the management of patients with acute myeloid leukemia. Hematol Cell Ther 38:231, 1996
23. Schiffer CA: Hematopoietic growth factors as adjuncts to the treatment of acute myeloid leukemia. Blood 88:3675, 1996
24. Büchner T, Hiddemann W, Wörmann B, Zühlsdorf M, Rottmann R, Innig G, Mashmeier G, Ludwig WD, Sauerland MC, Heinecke A: Hematopoietic growth factors in acute myeloid leukemia: Supportive and priming effects. Semin Oncol 24:124, 1997
25. Estey E, Dixon D, Kantarjian HM, Keating M, McCredie K, Bodey GP, Kurzrock R, Talpaz M, Freireich EJ, Deisseroth AB, Gutterman JU: Treatment of poor-prognosis, newly diagnosed acute myeloid leukemia with Ara-C and recombinant human granulocyte-macrophage colony-stimulating factor. Blood 75:1766, 1990
26. Rowe JM, Andersen JW, Mazza JJ, Bennett JM, Paietta E, Hayes FA, Oette D, Cassileth PA, Stadtmauer EA, Wiernick PH: 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 86:457, 1995
27. Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA, for the CALGB: Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. N Engl J Med 332:1671, 1995
28. Zittoun R, Suciu S, Mandelli F, de Witte T, Thaler J, Stryckmans P, Hayat M, Peetermans M, Cadiou M, Solbu G, Petti MC, Willemze R: 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 14:2150, 1996
29. Löwenberg B, Boogaerts MA, Vellenga E, Ossenkoppele G, Dekker AW, van der Lelie J, Schouten HC, Fopp M, Gratwohl A, Fey M, Gmür J, van Putten W: Various modalities of use of GM-CSF in the treatment of acute myelogenous leukemia (AML). A HOVON-SAKK randomized study (Hovon-4A). Blood 86:512a, 1995 (suppl 1, abstr)
30. Dombret H, Chastang C, Fenaux P, Reiffers J, Bordessoule D, Bouabdallah R, Mandelli F, Ferrant A, Auzanneau G, Tilly H, Yver A, Degos L for the AML Cooperative Study Group: A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia. N Engl J Med 332:1678, 1995
31. Heil G, Hoelzer D, Sanz MA, Lechner K, Liu Yin J, Papa G, Noens L, Ho J, O'Brien C, Matcham J, Barge A: Results of a randomized, double-blind placebo controlled phase III study of filgrastim in remission induction and early consolidation therapy for adults with de novo acute myeloid leukemia. Blood 86:267a, 1995 (suppl 1, abstr)
32. Godwin JE, Kopecky KJ, Head DR, Hynes HE, Balcerzack SP, Appelbaum FR: A double blind placebo controlled trial of G-CSF in elderly patients with previously untreated acute myeloid leukemia. A Southwest Oncology Group Study. Blood 86:434a, 1995 (suppl 1, abstr)
33. Link H, Wandt H, Schönrock-Nabulsi P, Ehninger G, Franke A, Gäckle R, Geer T, Gramatzki M, Linkesch W, Lutz D, Niederwieser D, Nikiforakis E, Ohl S, Otremba B, Pittermann E, Schmidt H, Tischler J, Weiss J, Wilhelm M, Deutschmann S: G-CSF after chemotherapy for acute myeloid leukemia (AML). Interim analysis of a placebo controlled trial. Br J Haematol 93:224, 1996 (abstr)
34. Moore JO, Dodge RK, Amrein PC, Kolitz J, Lee EJ, Powell B, Godfrey S, Robert F, Schiffer CA: Granulocyte-colony stimulating factor (filgrastim) accelerates granulocyte recovery after intensive postremission chemotherapy for acute myeloid leukemia with aziridinyl benzoquinone and mitoxantrone: Cancer and Leukemia Group B study 9022. Blood 89:780, 1997
35. Bettelheim P, Valent P, Andreeff M,Tafuri A, Haimi J, Gorischek C, Muhm M, Sillaber C, Haas O, Vieder L, Maurer D, Schulz G, Speiser W, Geissler K, Kier P, Hinterberger W, Lechner K: Recombinant human granulocyte-macrophage colony-stimulating factor in combination with standard induction chemotherapy in de novo acute myeloid leukemia. Blood 77:700, 1991
36. Estey E,Thall PF, Kantarjian H, O'Brien S, Koller CA, Beran M, Gutterman J, Deisseroth A, Keating M: 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 79:2246, 1992
37. Büchner T, Hiddemann W, Rottmann R, Wörmann B, Maschmeyer G, Ludwig WD, Sauerland MC, Frisch J, Schulz G: Multiple course chemotherapy with or without GM-CSF priming and longterm administration for newly diagnosed AML. Proc Am Soc Clin Oncol 12:301, 1993 (abstr)
38. Büchner T, Hiddemann W, Wörmann B, Rottmann R, Maschmeyer G, Ludwig WD, Zühlsdorf M, Buntkirchen K, Sander A, Aswald J, Binder I, Prisett S, Sauerland MC: Hematopoietic recovery and priming-therapeutic effects of GM-CSF in the treatment of AML, in Hiddemann W, Büchner T, Wörmann B, Ritter J, Creutzig M, Plunkett W, Keating M (eds): Haematology and Blood Transfusion-Acute Leukemia V. Berlin, Germany, Springer Verlag, 1996, p 145
39. Heil G, Chadid L, Hoelzer D, Seipelt G, Mitrou P, Huber C, Kolbe K, Mertelsmann R, Lindemann A, Frisch J, Nicolay U, Gaus W, Heimpel H: GM-CSF in a double-blind randomized, placebo controlled trial in therapy of adult patients with de novo acute myeloid leukemia. Leukemia 9:3, 1995
40. Löwenberg B, Suciu S, Archimbaud E, Ossenkoppele G, Verhoef GEG, Vellenga E, Wijermans P, Berneman Z, Dekker AW, Stryckmans P, Schouten H. Jehn U, Muus P, Sonneveld P, Dardenne M, Zittoun R on behalf of EORTC-LCG and HOVON: Use of recombinant granulocyte-macrophage colony-stimulating factor during and after remission induction chemotherapy in patients aged 61 and older with acute myeloid leukemia (AML): Final report of AML 11, a phase III randomized study of the Leukemia Cooperative Group of European Organization for the Research and Treatment of Cancer (EORTC-LCG) and the Dutch Belgian Hemato-Oncology Cooperative Group (HOVON). Blood 90:2952, 1997
41. Peterson BA, George SL, Bhalla K, Lee E, Carpenter JT, Berk GI, Schiffer CA: 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. Proc Am Soc Clin Oncol 15:3, 1996 (abstr)
42. Archimbaud E, Fenaux P, Reiffers J, Cordonnier C, Leblond V, Travade P, Troussard X, Tilly H, Auzanneau G, Marie JP, Ffrench M, Berger E: Granulocyte-macrophage colony-stimulating factor in association to timed-sequential chemotherapy with mitoxantrone, etoposide, and cytarabine for refractory acute myelogenous leukemia. Leukemia 7:372, 1993
43. Baer MR, Bernstein SH, Brunetto VL. Minderman H, Rustum Y, Block AW, Mrozek K, Bloomfield CD, Herzig GP: In vivo recombinant human G-CSF priming in previously untreated acute myeloid leukemia. Blood 26:328a, 1993 (suppl 1, abstr)
44. Estey E, Thall P, Andreeff M, Beran M, Kantarjian H, O'Brien S, Escudier S, Robertson LE, Koller C, Kornblau S, Pierce S, Freireich EJ, Deisseroth A, Keating M: 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 12:671, 1994
45. Ohno R, Naoe T, Kanamaru A, Yoshida M, Hiraoka A, Kobayashi T, Ueda T, Minami S, Morishima Y, Saito Y, Furusawa S, Imai K, Takemoto Y, Miura Y, Teshima H, Hamajima N, Kohseisho Leukemia Study Group: A double-blind controlled study of granulocyte colony-stimulating factor started two days before induction chemotherapy in refractory acute myeloid leukemia. Blood 83:2086, 1994