Multicenter randomized phase II trial of idarubicin vs mitoxantrone, combined with VP-16 and cytarabine for induction/consolidation therapy, followed by a feasibility study of autologous peripheral blood stem cell transplantation in elderly patients with acute myeloid leukemia
elderly AML; treatment; triple drug induction; idarubicin vs mitoxantrone; PBSC transplantation
Disciplines :
Hematology
Author, co-author :
Archimbaud, E.
Jehn, U.
Thomas, X.
De Cataldo, F.
Fillet, Georges ; Université de Liège - ULiège > Département des sciences cliniques > Hématologie - Oncologie médicale
Belhabri, A.
Peaud, P.-Y.
Martin, C.
Amadori, S.
Willemze, R.
Language :
English
Title :
Multicenter randomized phase II trial of idarubicin vs mitoxantrone, combined with VP-16 and cytarabine for induction/consolidation therapy, followed by a feasibility study of autologous peripheral blood stem cell transplantation in elderly patients with acute myeloid leukemia
Löwenberg B, Zittoun R, Kerkhofs H, Jehn U, Abels J, Debusscher L, Cauchie Ch, Peetermans M, Solbu G, Suciu S, Stryckmans P. On the value of intensive remission-induction chemotherapy in elderly patients of 65+ years with acute myeloid leukemia: a randomized phase III study of the European Organization for Research and Treatment of Cancer Leukemia Group. J Clin Oncol 1989; 7: 1268-1274.
Johnson PRE, Liu Yin JA. Acute myeloid leukaemia in the elderly: biology and treatment. Br J Haematol 1993; 83: 1-6.
Arlin Z, Case DC Jr, Moore J, Wiernik P, Feldman E, Saletan S, Desai P, Sia L, Cartwright K, and the Lederle Cooperative Group. Randomized multicenter trial of cytosine arabinoside with mitoxantrone or daunorubicin in previously untreated adult patients with acute nonlymphocytic leukemia (ANLL). Leukemia 1990; 4: 177-183.
Löwenberg B, Fiere D, Zittoun R, Kerkhofs H, Stryckmans P, De Cataldo F, Tura S, Peetermans M, Paulus R, Goudsmit R, Sonnenweld P, Solbu G, Suciu S. Mitoxantrone versus daunorubicin in induction of acute myelogenous leukemia elderly patients and low-dose ara-c vs control as maintenance. An EORTC phase II trial (AML-9). J Clin Oncol 1998; 16: 872-881.
Berman E, Heller G, Santorsa J, McKenzie S, Gee T, Kempin S, Gulati S, Andreeff M, Kolitz J, Gabrilove J, Reich L, Mayer K, Keefe D, Trainor K, Schluger A, Penenberg D, Raymond V, O'Reilly R, Jhanwar S, Young C, Clarkson B. 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.
Wiernik PH, Banks PLC, Case DC, Arlin ZA, Periman PO, Todd MB, Ritch PS, Enck RE, Weitberg AB. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood 1992; 79: 313-319.
Vogler WR, Velez-Garcia E, Weiner RS, Flaum MA, Bartolucci AA, Omura GA, Gerber MC, Banks PLC. A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group Study. J Clin Oncol 1992; 10: 1103-1111.
Bishop JF, Lowenthal RM, Joshua D, Matthews JP, Todd D, Cobcroft R, Whiteside MG, Kronenberg H, Ma D, Dodds A, Herrmann R, Szer J, Wolf MM, Young G, for the Australian Leukemia Study Group. Etoposide in acute nonlymphocytic leukemia. Blood 1990; 75: 27-32.
Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, Leoni F, Damasio E, Visani C, Papa G, Caronia F, Hayat M, Stryckmans P, Rotoli B, Leoni P, Peetermans ME, Dardenne M, Vegna ML, Petti MC, Solbu G, Suciu S, for the European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo ltaliano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. New Engl J Med 1995; 332: 217-223.
Meloni G, De Fabriitis P, Petti MC, Mandelli F. BAVC regimen and autologous bone marrow transplantation in patients with acute myelogenous leukemia in second remission. Blood 1990; 75: 2282-2285.
Blay JY, Soler P, Chauvin F, Vial C, Colombat P, Janvier M, Giroux B, Philip I, Biron P. High dose nitrosurea followed by ABMT and radiotherapy in high grade astrocytoma. In: Dicke KA, Keating A (eds). Autologous Bone Marrow Transplantation. Proc Sixth Int Symp. Cancer Treatment Research Education Fund: Arlington, Texas, 1994, p 215.
Rule SA, Savage DG, O'Brien SG, Orchard K, McDonald C, Davidson J, Matthey F, Reilly JT, Bardhan G, Miller E, Cranfield T, Apperley JF, Goldman JM. Intermediate-dose busulphan before autografting for advanced-phase chronic myeloid leukemia. Br J Haematol 1996; 94: 694-698.
Reiffers J, Labopin M, Körbling M, Henon Ph, Gorin NC. Autologous blood stem cell transplantation versus autologous bone marrow transplantation for acute myeloid leukemia in first remission: a retrospective analysis of the EBMT registry. Proc 18th Annual Meeting of the European Group for Bone Marrow Transplantation. Stockholm, 1992, p 107.
Reiffers J, Stoppa AM, Attal M, Michallet M. Is there a place for blood stem cell transplantation for the younger adult patient with acute myelogenous leukemia? J Clin Oncol 1994; 12: 1100-1102.
Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton 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 1985; 103: 620-625.
Ellison RR, Holland JF, Weil M, Jacquillat C, Boiron M, Bernard J, Sawitsky A, Rosner F, Gussoff B, Silver RT, Karanas A, Cuttner J, Spurr CL, Hayes DM, Bloom J, Leone LA, Haurani F, Kyle R, Hutchison JL, Forcier RJ, Moon JH. Arabinosyl cytosine: a useful agent in the treatment of acute leukemia in adults. Blood 1968; 32: 507-523.
Preisler HD. Failure of remission induction in acute myelocytic leukemia. Med Ped Oncol 1978; 4: 275-276.
Arthur DC, Berger R, Golomb HM. The clinical significance of karyotype in acute myelogenous leukemia. Cancer Genet Cytogenet 1989; 40: 203-218.
Schiffer CA, Lee EJ, Tomiyasu T. Prognostic impact of cytogenetic abnormalities in patients with de novo acute nonlymphocytic leukemia. Blood 1989; 73: 263-270.
Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. JAMA 1958; 53: 457-481.
Rees JKH, Gray RG, Wheatley K. Dose intensification in acute myeloid leukaemia: greater effectiveness at lower cost. Principal report of the Medical Research Council's AML 9 study. Br J Haematol 1996; 94: 89-98.
Bow EJ, Sutherland JA, Kilpatrick MG, Williams GJ, Clinch JJ, Shore TB, Rubinger M, Schacter BA. Therapy of untreated acute myeloid leukemia in the elderly: remission induction using a non-cytarabine-containing regimen of mitoxantrone plus etoposide. J Clin Oncol 1996; 14: 1345-1352.
Feldman EJ, Seiter K, Damon L, Linker C, Rugo H, Ries C, Case Jr DC, Beer M, Ahmed T. A randomized trial of high-vs standard-dose mitoxantrone with cytarabine in elderly patients with acute myeloid leukemia. Leukemia 1997; 11: 485-489.
Leith CP, Kopecky KJ, Godwin J, McConnell T, Slovak ML, Chen IM, Head DR, Appelbaum FR, Willman CL 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.
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. Use of recombinant granulocyte-macrophage colony-stimulating factor during and after remission induction chemotherapy in patients aged 61 years and older with acute myeloid leukemia (AML): final report of AMI 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 1997; 90: 2952-2961.
Reiffers J, Huguet F, Stoppa AM, Molina L, Marit G, Attal M, Gastaut JA, Michallet M, Lepeu G, Broustet A, Pris J, Maraninchi D, Hollard D, Faberès C, Mercier M, Hurteloup P, Danel P, Tellier Z, Berthaud P. A prospective randomized trial of idarubicin vs daunorubicin in combination chemotherapy for acute myelogenous leukemia of the age group 55 to 65. Leukemia 1996; 10: 389-395.
Hann IM, Stevens RF, Goldstone AH, Rees JKH, Wheatley K, Gray RG, Burnett AK. Randomized comparison of DAT versus ADE as induction chemotherapy in children and younger adults with acute myeloid leukemia. Results of the Medical Research Council's 10th AML Trial (MRC AML 10). Blood 1997; 89: 2311-2318.
Mandelli F, Petti MC, Ardia A, Di Pietro N, Di Raimondo F, Ganzina F, Falconi E, Geraci E, Ladogana S, Latagliata R, Malleo C, Nobile F, Petti N, Rotoli B, Specchia G, Tabilio A, Resegotti L. A randomised Clinical trial comparing idarubicin and cytarabine to daunorubicin and cytarabine in the treatment of acute non-lymphoid leukemia. Eur J Cancer 1991; 27: 750-755.
Terpstra W, Löwenberg B. Application of myeloid growth factors in the treatment of acute myeloid leukemia. Leukemia 1997; 11: 315-327.
Dombret H, Chastang C, Fenaux P, Reiffers J, Bordessoule D, Bouabdallah R, Mandelli F, Ferrant A, Auzanneau G, Tilly H, Yver A, Degos L. A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia. New Engl J Med 1995; 332: 1678-1683.
Link H, Wandt H, Schönrock-Nabulsi P, Ehninger G, Franke A, Gäckle R, Geer T, Strobel G, Linkesch W, Krieger O, Niederwieser D, Nikiforakis E, Ohl S, Otremba B, Pittermann E, Schmidt H, Tischler J, WieJ, Wilhelm M, Badri N. G-CSF (lenograstim) after chemotherapy for acute myeloid leukemia: a placebo controlled trial. Blood 1996; 88 (Suppl.): 666a.
Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura G, Moore JO, McIntyre OR, Frei III E. Intensive postremission therapy in adults with acute myeloid leukemia. New Engl J Med 1994; 331: 896-903.
Weick JK, Kopecky KJ, Appelbaum FR, Head DR, Kingsbury LL, Balcerzak SP, Bickers JN, Hynes HE, Welborn JL, Simon SR, Grever M. A randomized investigation of high-dose versus standard-dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: a Southwest Oncology Group study. Blood 1996; 88: 2841-2851.
Schiller G, Lee M. Long-term outcome of high-dose cytarabine-based consolidation chemotherapy for older patients with acute myelogenous leukemia. Leuk Lymphoma 1997; 25: 111-119.
Burnett AK. Evaluation of chemotherapy, allogeneic and autologous bone marrow transplants for the treatment of AML. Bone Marrow Transplant 1997; 19 (Suppl. 1): S160.
Ferrant A, Labopin M, Frassoni F, Prentice HG, Cahn JY, Biaise D, Reiffers J, Visani G, Sanz MA, Boogaerts MA, Lowenberg B, Gorin NC. Karyotype in acute myeloblastic leukemia: prognostic significance for bone marrow transplantation in first remission. A European Group for Blood and Marrow Transplantation study. Blood 1997; 90: 2931-2938.