Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: Azacitidine compared with low dose ara-C: Research paper

British Journal of Haematology

Volumn 149, Issue 2, 2010, Pages 244-249

  Fenaux, Pierre ^a,l   Gattermann, Norbert ^b   Seymour, John F ^c   Hellström Lindberg, Eva ^d   Mufti, Ghulam J ^e   Duehrsen, Ulrich ^f   Gore, Steven D ^g   Ramos, Fernando ^h   Beyne Rauzy, Odile ⁱ   List, Alan ^j   McKenzie, David ^k   Backstrom, Jay ^k   Beach, Charles L ^k  

^a AVICENNE HOSPITAL   (France)

^b HEINRICH HEINE UNIVERSITY   (Germany)

^c UNIVERSITY OF MELBOURNE   (Australia)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e KING'S COLLEGE LONDON   (United Kingdom)

^f UNIVERSITY HOSPITAL ESSEN   (Germany)

^g JOHNS HOPKINS UNIVERSITY   (United States)

^h UNIVERSITY OF LEÓN   (Spain)

ⁱ CHU PURPAN   (France)

^j H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^k CELGENE CORPORATION   (United States)

^l ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

more..

Author keywords

Azacitidine; Higher risk myelodysplastic syndromes; Low dose cytarabine (ara C); Myelodysplastic syndromes; Survival

Indexed keywords

AZACITIDINE; CYTARABINE; HEMOGLOBIN;

ADULT; AGED; ANEMIA; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; CYTOPENIA; DRUG EFFICACY; DRUG EXPOSURE; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; FEMALE; GENETIC RISK; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REFRACTORY ANEMIA WITH EXCESS BLASTS; REFRACTORY ANEMIA WITH EXCESS BLASTS IN TRANSFORMATION; SURVIVAL TIME; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; AZACITIDINE; CYTARABINE; DRUG ADMINISTRATION SCHEDULE; ERYTHROCYTE TRANSFUSION; FEMALE; HUMANS; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 77949823230     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2010.08082.x     Document Type: Article

References (23)

1. Alessandrino, E.P., Amadori, S., Barosi, G., Cazzola, M., Grossi, A., Liberato, L.N., Locatelli, F., Marchetti, M., Morra, E., Rebulla, P., Visani, G. Tura, S. (2002) Evidence- and consensus-based practice guidelines for the therapy of primary myelodysplastic syndromes. A statement from the Italian Society of Hematology. Haematologica, 87, 1286 1306.
2. Bowen, D., Culligan, D., Jowitt, S., Kelsey, S., Mufti, G., Oscier, D., Parker, J. UK MDS Guidelines Group (2003) Guidelines for the diagnosis and therapy of adult myelodysplastic syndromes. British Journal of Haematology, 120, 187 200.
3. Burnett, A.K., Milligan, D., Prentice, A.G., Goldstone, A.H., McMullin, M.F., Hills, R.K., Wheatley, K. National Cancer Research Institute Haematological Oncology Study Group Adult Leukemia Working Party (2007) A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer, 109, 1114 1124.
4. Cheson, B.D. Simon, R. (1987) Low-dose ara-C in acute nonlymphocytic leukemia and myelodysplastic syndromes: a review of 20 years' experience. Seminars in Oncology, 14, 126 133.
5. Detourmignies, L., Wattel, E., Lai, J.L., Bauters, F. Fenaux, P. (1993) Is there a role for low-dose cytarabine arabinoside in de novo acute myeloid leukemia in the elderly? Annals of Hematology, 66, 235 240.
6. Faderl, S., Ravandi, F., Huang, X., Garcia-Manero, G., Ferrajoli, A., Estrov, Z., Borthakur, G., Verstovsek, S., Thomas, D.A., Kwari, M. Kantarjian, H.M. (2008) A randomized study of clofarabine plus low-dose cytarabine as front-line therapy for patients age 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood, 112, 1638 1645.
7. Fenaux, P., Lai, J.L., Gardin, C. Bauters, F. (1990) Cytogenetics are a predictive factor of response to low-dose ara-C in acute myelogenous leukemia (AML) in the elderly. (Letter) Leukemia, 4, 312.
8. Fenaux, P., Mufti, G.J., Hellstrom-Lindberg, E., Santini, V., Finelli, C., Giagounidis, A., Schoch, R., Gattermann, N., Sanz, G., List, A., Gore, S.D., Seymour, J.F., Bennett, J.M., Byrd, J., Backstrom, J., Zimmerman, L., McKenzie, D., Beach, C.L., Silverman, L.R. International Vidaza High-risk MDS Survival Study Group (2009) Efficacy of azacitidine compared with conventional care regimens in higher-risk myelodysplastic syndromes: results of a randomised, phase III study. The Lancet Oncology, 10, 223 232.
9. Gore, S.D., Baylin, S., Sugar, E., Carraway, H., Miller, C.B., Carducci, M., Grever, M., Galm, O., Dauses, T., Karp, J.E., Rudek, M.A., Zhao, M., Smith, B.D., Manning, J., Jiemjit, A., Mays, A., Zwiebel, J., Murgo, A., Weng, L.J. Herman, G.J. (2006) Combined DNA methyltransferase and histone deacetylase inhibition in the treatment of myeloid neoplasms. Cancer Research, 66, 6361 6369.
10. Greenberg, P., Cox, C., LeBeau, M.M., Fenaux, P., Morel, P., Sanz, G., Sanz, M., Vallespi, T., Hamblin, T., Oscier, D., Ohyashiki, K., Toyama, K., Aul, C., Mufti, G. Bennett, J. (1997) International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood, 89, 2079 2098.
11. Hellstrom-Lindberg, E., Robert, K.-H., Gahrton, G., Lindberg, G., Forsblom, A.-M., Kock, Y. Ost, A. (1992) A predictive model for the clinical response to low dose ara-C: a study of 102 patients with myelodysplastic syndromes or acute leukemia. British Journal of Haematology, 81, 503 511.
12. Housset, M., Daniel, M.T. Degos, L. (1982) Small doses of ara-C in the treatment of acute myeloid leukemia: differentiation of myeloid leukemia cells? British Journal of Haematology, 51, 125 129.
13. Kurzrock, R. (2002) Myelodysplastic syndrome overview. Seminars in Hematology, 39, 18 25.
14. Leyden, M., Manoharan, A., Boyd, A., Cheng, Z.M. Sullivan, J. (1984) Low dose cytosine arabinoside: partial remission of acute myeloid leukaemia without evidence of differentiation induction. British Journal of Haematology, 57, 301 307.
15. Miller, K.B., Kyungmann, K., Morrison, F.S., Winter, J.N., Bennett, J.M., Neiman, R.S., Head, D.R., Cassileth, P.A. O'Connell, M.J. (1992) The evaluation of low-dose cytarabine in the treatment of myelodysplastic syndromes: a phase-III intergroup study. Annals of Hematology, 65, 162 168.
16. Mufti, G.J., Fenaux, P., Hellstrom-Lindberg, E., Santini, V., List, A.F., Gore, S., Seymour, J.F., Silverman, L.R., Backstrom, J. Beach, C.L. (2008) Treatment of high-risk MDS patients (pts) with -7/del(7q) with azacitidine (AZA) versus conventional care regimens (CCR): effects on overall survival (OS). Journal of Clinical Oncology, 26, 380 s, Abstract 7033.
17. Nair, R., Nair, C.N. Advani, S.H. (1998) All trans retinoic acid with low-dose cytosine arabinoside in the treatment of myelodysplastic syndrome. Leukemia & Lymphoma, 29, 187 192.
18. Raj, K., John, A., Ho, A., Thomas, N.S.B. Mufti, G.J. (2006) Early and sustained response to azacitidine occurs in high risk MDS patients with monosomy 7: responses correlate with increased apoptosis not CDKN2B demethylation. British Journal of Haematology, 133, 61 62. Abstract 111.
19. Raj, K., John, A., Ho, A., Chronis, C., Khan, S., Samuel, J., Pomplun, S., Thomas, N.S.B. Mufti, G.J. (2007) CDKN2B methylation status and isolated chromosome 7 abnormalities predict responses to treatment with 5-azacytidine. Leukemia, 21, 1937 1944.
20. Roboz, G.J., Ritchie, E.K., Curcio, T., Provenzano, J., Carlin, R., Samuel, M., Wittenberg, B., Mazumdar, M., Christos, P.J., Mathew, S., Allen-Bard, S. Feldman, E.J. (2008) Arsenic trioxide and low-dose cytarabine in older patients with untreated acute myeloid leukemia, excluding acute promyelocytic leukemia. Cancer, 113, 2504 2511.
21. Silverman, L.R., Demakos, E.P., Peterson, B.L., Kornblith, A.B., Holland, J.C., Odchimar-Reissig, R., Stone, R.M., Nelson, D., Powell, B.L., DeCastro, C.M., Ellerton, J., Larson, R.A., Schiffer, C.A. Holland, J.F. (2002) Randomized controlled trial of azacitidine in patients with myelodysplastic syndrome: a study of the Cancer and Leukemia Group B. Journal of Clinical Oncology, 20, 2429 2440.
22. Visani, G., Malagola, M., Piccaluga, P.P. Isidori, A. (2004) Low-dose ara-C for myelodysplastic syndromes: is it still a current therapy? Leukemia & Lymphoma, 45, 1531 1538.
23. Zwierzina, H., Suciu, S., Loeffler-Ragg, J., Neuwirtova, R., Fenaux, P., Becsak, M., Harousseau, J., Nuessler, V., Cermak, J., Solbu, G., Willemze, R., de Witte, T., Amadori, S. EORTC Leukemia Cooperative Group (2005) Low-dose cytosine arabinoside (LD-AraC) vs LD-AraC plus granulocyte/macrophage colony stimulating factor vs LD-AraC plus interleukin-3 for myelodysplastic syndrome patients with a high risk of developing acute leukemia: final results of a randomized phase III study (06903) of the EORTC Leukemia Cooperative Group. Leukemia, 19, 1929 1933.