High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study

Annals of Hematology

Volumn 86, Issue 2, 2007, Pages 117-125

  Deenik, W ^a   van der Holt, B ^k   Verhoef, G E G ^b   Schattenberg, A V M B ^c   Verdonck, L F ^d   Daenen, S M G J ^e   Zachee P ^f   Westveer, P H M ^k   Smit, W M ^g   Wittebol, S ^h   Schouten, H C ⁱ   Lowenberg B ^a   Ossenkoppele, G J ^j   Cornelissen, J J ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^g MEDISCH SPECTRUM TWENTE   (Netherlands)

^h MEANDER MEDICAL CENTER   (Netherlands)

ⁱ MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^j VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^k Hovon Data Center   (Netherlands)

more..

Author keywords

Allogeneic stem cell transplantation; Chronic myeloid leukemia; Cytarabine; Cytogenetic response; Interferon alfa

Indexed keywords

ALPHA INTERFERON; BUSULFAN; CYCLOPHOSPHAMIDE; CYTARABINE; HLA ANTIGEN; HYDROXYUREA; IDARUBICIN; IMATINIB;

ADOLESCENT; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ALLOGENEIC STEM CELL TRANSPLANTATION; ARTICLE; BLAST CELL CRISIS; BLOOD TOXICITY; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; DIARRHEA; DISEASE EXACERBATION; DONOR; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG FEVER; DRUG MEGADOSE; DRUG RESPONSE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; DYSPNEA; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HUMAN; INFECTION; LIVER FUNCTION; LOW DRUG DOSE; LYMPHOCYTE TRANSFUSION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIBLING; SIDE EFFECT; SKIN DEFECT; SURVIVAL RATE;

ADOLESCENT; ADULT; AGED; CYTARABINE; CYTOGENETICS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INTERFERON-ALPHA; LEUKEMIA, MYELOID, CHRONIC-PHASE; MALE; MIDDLE AGED; STEM CELL TRANSPLANTATION; SURVIVAL RATE; TRANSPLANTATION, HOMOLOGOUS;

EID: 33845713974     PISSN: 09395555     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00277-006-0186-1     Document Type: Article

References (32)

1. Rowley JD (1973) A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature 243:290-293
2. Daley GQ, Van Etten RA, Baltimore D (1990) Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science 344:251-253
3. Guilhot F, Chastang C, Michallet M, Guerci A, Harousseau JL, Maloisel F, Bouabdalla R, Guyotat D, Cheron N, Nicolini F, Abgrall JF, Tanzer J (1997) Interferon alpha-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia. N Engl J Med 337:223-229
4. Janssen JJ, van Rijn RS, van der Holt B, Schuurhuis GJ, Vellenga E, Verhoef GE, Ossenkoppele GJ, van den Berg E, Hagemeijer A, Slater R, Nieuwint AW, Cornelissen JJ (2000) Mobilisation of haemopoietic progenitors in CML: A second course of intensive chemotherapy does not improve Ph-negativity in stem cell harvests. Bone Marrow Transplant 25:1147-1155
5. Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E (1994) Intensive post-remission chemotherapy in adults with acute myeloid leukemia. N Engl J Med 331:896-903
6. Bishop JF, Matthews JP, Young GA, Szer J, Gillett A, Joshua D, Bradstock K, Enno A, Wolf MM, Fox R (1996) A randomized study of high-dose cytarabine in induction in acute myeloid leukemia. Blood 87:1710-1717
7. Cunningham I, Gee T, Dowling M, Chaganti R, Bailey R, Hopfan S, Bowden L, Turnbull A, Knapper W, Clarkson B (1979) Results of treatment of Ph'+ chronic myelogenous leukemia with an intensive treatment regimen (L-5 protocol). Blood 53:375-395
8. Kantarjian HM, Vellekoop L, McCredie KB, Keating MJ, Hester J, Smith T, Barlogie B, Trujillo J, Freireich EJ (1985) Intensive combination chemotherapy (ROAP 10) and splenectomy in the management of chronic myelogenous leukemia. J Clin Oncol 3:192-200
9. Kantarjian HM, Talpaz M, Keating MJ, Estey EH, O'Brien S, Beran M, McCredie KB, Gutterman J, Freireich EJ (1991) Intensive chemotherapy induction followed by Interferon-alpha maintenance in patients with Philadelphia chromosome-positive chronic myelogenous leukemia. Cancer 68:1201-1207
10. Giles FJ, Kantarjian H, O'Brien S, Rios MB, Cortes J, Beran M, Koller C, Keating M, Talpaz M (2001) Results of therapy with interferon alpha and cyclic combination chemotherapy in patients with Philadelphia chromosome positive chronic myelogenous leukemia in early chronic phase. Leuk Lymphoma 41:309-319
11. Holyoake TL, Jiang X, Eaves C, Eaves A (1999) Isolation of a highly quiescent subpopulation of primitive leukemic cells in chronic myeloid leukaemia. Blood 94:2056-2064
12. Holyoake TL, Jiang X, Jorgensen HG, Graham S, Alcorn MJ, Laird C, Eaves AC, Eaves CJ (2001) Primitive quiescent leukemic cells from patients with chronic myeloid leukaemia spontaneously initiate factor-independent growth in vitro in association with up-regulation of expression of interleukin-3. Blood 97:720-728
13. Bhatia R, Holtz M, Niu N, Gray R, Snyder DS, Sawyers CL, Arber DA, Slovak ML, Forman SJ (2003) Persistence of malignant hematopoietic progenitors in chronic myelogenous leukemia patients in complete cytogenetic remission following imatinib mesylate treatment. Blood 101:4701-4707
14. Graham SM, Jorgensen HG, Allan E, Pearson C, Alcorn MJ, Richmond L, Holyoake TL (2002) Primitive, quiescent, Philadelphia-positive stem cells from patients with chronic myeloid leukaemia are insensitive to STI571 in vitro. Blood 99:319-325
15. Allan NC, Richards SM, Shepherd PCA (1995) UK Medical Research Council randomised, multicentre trial of interferon-αn1 for chronic myeloid leukaemia: Improved survival irrespective of cytogenetic response. Lancet 345:1392-1397
16. Kluin-Nelemans HC, Buck G, le Cessie S, Richards S, Beverloo HB, Falkenburg JHF, Littlewood T, Muus P, Bareford D, van der Lelie H, Green AR, Roozendaal KJ, Milne AE, Chapman CS, Shepherd P for the UK CML Working Group of NCRI and the HOVON trials group (2004) Randomized comparison of low-dose versus high-dose interferon-alfa in chronic myeloid leukemia: Prospective collaboration of 3 joint trials by the MRC and HOVON groups. Blood 103:4408-4415
17. McGlave PB, De Fabritiis P, Deisseroth A, Goldman J, Barnett M, Reiffers J, Simonsson B, Carella A, Aeppli D (1994) Autologous transplants for chronic myelogenous leukaemia: Results from eight transplant groups. Lancet 343:1486-1488
18. Simonsson B, Öberg G, Björeman M, Björkholm M, Carneskog J, Gahrton G, Hast R, Karl H, Lanng-Nielsen J, Lofvenberg E, Malm C, Turesson I, Uden AM, Vilen L, Weis-Bjerrum O (1996) Intensive treatment in order to minimize the Ph-positive clone in CML. Bone Marrow Transplant 17:S63-S64
19. Olavarria E, Reiffers J, Boque C, Sureda A, Meloni G, Michallet M, Clark RE, Blaise D, Carella AM, Cahn JY, Jouet JP, Rizzoli V, Van Biezen A, Gratwohl A, Goldman JM, Niederwieser D, Apperley JF (2002) The post-transplant cytogenetic response to interferon is a major determinant of survival after autologous stem cell transplantation for chronic myeloid leukaemia in chronic phase. Br J Haematol 119:762-770
20. O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ (2003) Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia. N Engl J Med 348:994-1004
21. Hughes TP, Kaeda J, Branford S, Rudzki Z, Hochhaus A, Hensley ML, Gathmann I, Bolton AE, van Hoomissen IC, Goldman JM, Radich JP (2003) Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukaemia. N Engl J Med 349:1423-1432
22. Goldman J (2004) Monitoring minimal residual disease in BCR-ABL-positive chronic myeloid leukaemia in the imatinib era. Curr Opin Hematol 12:33-39
23. Roche-Lestienne C, Soenen-Cornu V, Grardel-Duflos N, Lai JL, Philippe N, Facon T, Fenaux P, Preudhomme C (2002) Several types of mutations of the Abl gene can pre-exist to the onset, of treatment. Blood 100:1014-1018
24. Gorre ME, Mohammed M, Ellwood K, Hsu N, Paquette R, Rao PN, Sawyers CL (2001) Clinical resistance to STI-571 cancer therapy caused by BCR-ABL gene mutation or amplification. Science 292:876-880
25. Marktel S, Marin D, Foot N, Szydlo R, Bua M, Karadimitris A, De Melo VA, Kotzampaltiris P, Dazzi F, Rahemtulla A, Olavarria E, Apperley JF, Goldman JM (2003) Chronic myeloid leukaemia in chronic phase responding to imatinib: The occurrence of additional cytogenetic abnormalities predicts disease progression. Hematologica 88:260-267
26. Mahon FX, Deininger MW, Shultheis B, Chabrol J, Reiffers J, Goldman JM, Melo JV (2000) Selection and characterization of BCR-ABL positive cell lines with differential sensitivity to the tyrosine kinase inhibitor STI571: Diverse mechanisms of resistance. Blood 96:1070-1079
27. Gambacorti-Passerini C, Zucchetti M, Russo D, Frapolli R, Verga M, Bungaro S, Tornaghi L, Rossi F, Pioltelli P, Pogliani E, Alberti D, Corneo G, D'Incalci M (2003) Alpha1 acid glycoprotein binds to imatinib (STI571) and substantially alters its pharmacokinetics in chronic myeloid leukemia patients. Clin Cancer Res 9:625-632
28. Deininger M, Buchdunger E, Druker BJ (2005) The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood 105:2640-2653
29. Gardembas M, Rousselot P, Tulliez M, Vigier M, Buzyn A, Rigal-Huguet F, Legros L, Michallet M, Berthou Ch, Cheron N, Maloisel F, Mahon F-X, Facon T, Berthaud P, Guilhot J, Guilhot F for the CML French Group (2003) Results of a prospective phase 2 study combining imatinib mesylate and cytarabine for the treatment of Philadelphia-positive patients with chronic myelogenous leukaemia in chronic phase. Blood 102:4298-4305
30. Cornelissen JJ, Valk P, Verhoef GEG, Smit WM, van Marwijk-Kooij M, Wittebol S, van Oers MHJ, Kluin-Nelemans HC, Lowenberg B, Willemze R, Schattenberg AVMB, Ossenkoppele G (2004) High rates of molecular response and low incidence of mutations in patients treated with newly diagnosed chronic myeloid leukaemia (CML) treated with a dose-escalated combination of imatinib and cytarabine. Blood 104(11) (Abstract 19)
31. Thiesing JT, Sayuri OJ, Kolibaba KS, Druker BJ (2002) Efficacy of STI571, an Abl tyrosine kinase inhibitor, in conjunction with other antileukemic agents against Bcr-Abl-positive cells. Neoplasia 96:3195-3199
32. La Rosee P, O'Dwyer ME, Druker BJ (2002) Insights from pre-clinical studies for new combination treatment regimens with the Bcr-Abl kinase inhibitor imatinib mesylate (Gleevec/Glivec) in chronic myelogenous leukemia: A translational perspective. Leukemia 16:1213-1219