Topotecan and cytarabine is an active combination regimen in myelodysplastic syndromes and chronic myelomonocytic leukemia

Journal of Clinical Oncology

Volumn 17, Issue 9, 1999, Pages 2819-2830

  Beran, Miloslav ^a   Estey, Elihu ^a   O'Brien, Susan ^a   Cortes, Jorge ^a   Koller, Charles A ^a   Giles, Francis J ^a   Kornblau, Steven ^a   Andreeff, Michael ^a   Vey, Norbert ^a   Pierce, Sherry R ^a   Hayes, Kimberly ^a   Wong, Gee Chuan ^a   Keating, Michael ^a   Kantarjian, Hagop ^a  

^a SINGAPORE GENERAL HOSPITAL   (Singapore)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTIFUNGAL AGENT; ANTINEOPLASTIC AGENT; ANTIVIRUS AGENT; CYTARABINE; FLUDARABINE; GRANULOCYTE COLONY STIMULATING FACTOR; IDARUBICIN; RETINOIC ACID; TOPOTECAN;

ADULT; AGED; ANTIBIOTIC PROPHYLAXIS; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER REGRESSION; CANCER SURVIVAL; CHRONIC MYELOMONOCYTIC LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENETIC SUSCEPTIBILITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MUCOSA INFLAMMATION; MYELODYSPLASTIC SYNDROME; PRIORITY JOURNAL; PROGNOSIS; PYREXIA IDIOPATHICA; RANDOMIZED CONTROLLED TRIAL; RASH; REFRACTORY ANEMIA;

EID: 0032884937     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.9.2819     Document Type: Article

References (60)

1. Bennett JM: Classification of the myelodysplastic syndromes. Clin Haematol 15:909-923, 1986
2. Bennett JM, Catovsky D, Daniel MT, et al: Proposals for the classification of the myelodysplastic syndromes. Br J Haematol 51:189-199, 1982
3. Aul C, Gatterman N, Schneider W: Age-related incidence and other epidemiological aspects of myelodysplastic syndromes. Br J Haematol 82:358-367, 1992
4. Aul C, Gattermann N, Germing U, et al: Risk assessment in primary myelodysplastic syndromes: Validation of the Düsseldorf score. Leukemia 8:1906-1913, 1994
5. Sanz GH, Sanz MA, Vallespi T, et al: Two regression models and a scoring system for predicting survival and planning treatment in myelodysplastic syndromes: A multivariate analysis of prognostic factors in 370 patients. Blood 74:395-408, 1989
6. Mufti GJ, Stevens JR, Oscier DG, et al: Myelodysplastic syndromes: A scoring system with prognostic significance. Br J Haematol 59:425-433, 1985
7. Kerkhofs H, Hermans J, Haak HL, et al: Utility of the FAB classification for myelodysplastic syndromes: Investigation of prognostic factors in 237 cases. Br J Haematol 65:73-81, 1987
8. Vallespi T, Torrabadella M, Julia A, et al: Myelodysplastic syndromes: A study of 101 cases according to the FAB classification. Br J Haematol 61:83-92, 1985
9. Jacobs RH, Combleet MA, Vardiman JW, et al: Prognostic implications of morphology and karyotype in primary myelodysplastic syndromes. Blood 67:1765-1772, 1986
10. Coiffier B, Adeleine P, Gentilhomme O, et al: Myelodysplastic syndromes: A multiparametric study of prognostic factors in 336 patients. Cancer 60:3029-3032, 1987
11. Morel P, Hebbar M, Lai JL, et al: Cytogenetic analysis has strong independent prognostic value in de novo myelodysplastic syndromes and can be incorporated in a new scoring system: A report on 408 cases. Leukemia 7:1315-1323, 1993
12. Greenberg P, Cox C, Le Beau MM, et al: International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 89:2079-2088, 1997
13. Estey E, Keating M, Pierce S, et al: Application of the International Scoring System for Myelodysplasia to M.D. Anderson patients. Blood 90:2843-2844, 1995
14. Bennett JM, Catovsky D, Daniel MT, et al: The chronic myeloid leukaemias: Guidelines for distinguishing chronic granulocytic, atypical chronic myeloid and chronic myelomonocytic leukaemia. Br J Haematol 87:746-754, 1994
15. Michaux J-L, Martial P: Chronic myelomonocytic leukaemia (CMML): A myelodysplastic or myeloproliferative syndrome? Leuk Lymphoma 9:35-41, 1993
16. Cambier N, Baruchel A, Schlageter MH, et al: Chronic myelomonocytic leukemia: From biology to therapy. Hematol Cell Ther 39:41-48, 1997
17. Fenaux P, Beuscart R, Luc Lai J, et al: Prognostic factors in adult chronic myelomonocytic leukemia: An analysis of 107 cases. J Clin Oncol 6:1417-1424, 1988
18. Martial P, Michaux JL, Rodhain J: Philadelphia-negative (Ph-) chronic myeloid leukemia (CML): Comparison wilh Ph+ CML and chronic myelomonocylic leukemia - The Groupe Francais de Cytogenetique Hematologique. Blood 78:205-211, 1991
19. Kantarjian HM, Keating MJ, Walters RS, et al: Clinical and prognostic features of Philadelphia chromosome negative chronic myelogenous leukemia. Cancer 58:2023-2030, 1986
20. Kantarjian HM, Kurzrock R, Talpaz M, et al: Philadelphia chromosome-negative chronic myelogenous leukemia and chronic myelomonocytic leukemia, in Canellos GP (ed): Hematology/Oncology Clinics of North America (vol 4). Philadelphia, PA, WB Saunders Co, 1990, pp 389-404
21. Greenberg P, Taylor K, Larson R, et al: Phase III randomized mullicenter trial of G-CSF vs observation for myelodysplastic syndromes (MDS). Blood 82:196, 1993 (abstr 768)
22. Schuster MW, Thompson JA, Larson R, et al: Randomized trial of subcutaneous granulocyte-macrophage colony stimulating factor (GM-CSF) versus observation in patients with myelodysplastic syndromes or aplastic anemia. J Clin Oncol 9:205, 1990 (abstr 205)
23. Hellström-Lindberg E: Efficacy of erythropoietin in the myelodysplastic syndromes: A meta-analysis of 205 patients from 17 studies. Br J Haematol 89:67-71, 1995
24. Cheson BD, Jasperse DM, Simon R, et al: A critical appraisal of low-dose cytosine arabinoside in patients with acute non-lymphocytic leukemia and myelodysplastic syndromes. J Clin Oncol 4:1857-1864, 1986
25. Miller KB, Kim K, Morrison FS, et al: The evaluation of low-dose cytarabine in the treatment of myelodysplastic syndromes: A phase III intergroup study. Ann Hematol 66:164-170, 1993
26. Beran M, Keating MJ, McCredie KB: Biological features of myelodysplastic syndromes (MDS) predicts for survival and therapy response, in Uchino H, Takaku F, Yoshida Y (eds): Myelodysplastic Syndromes Pathophysiology and Treatment. Amsterdam, the Netherlands, Excerpta Medica, 1988, pp 155-172
27. Bernstein SH, Brunetto VL, Davey FR, et al: Acute myeloid leukemia-type chemotherapy for newly diagnosed patients without antecedent cytopenias having myelodysplastic syndrome as defined by French-American-British criteria: A Cancer and Leukemia Group B study. J Clin Oncol 14:2486-2491, 1996
28. Estey E, Thall P, Beran M, et al: Effect of diagnosis (refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or acute myeloid leukemia [AML]) on outcome of AML-type chemotherapy. Blood 90:2969-2977, 1997
29. Estey E, Pierce S, Kantarjian H, et al: Treatment of myelodysplastic syndromes with AML-type chemotherapy. Leuk Lymphoma 11:59-63, 1993
30. Armitage JO, Dick FR, Needleman SW, et al: Effect of chemotherapy for the dysmyelopoietic syndrome. Cancer Treat Rep 65:601-605, 1981
31. Mertelsmann R, Thaler HT, To L, et al: Morphological classification, response to therapy, and survival in 263 adult patients with acute nonlymphoblastic leukemia. Blood 56:733-776, 1980
32. Wattel E, De Botton S, Luc Laï J, et al: Long-term follow-up of de novo myelodysplastic syndromes treated with intensive chemotherapy: Incidence of long-term survivors and outcome of partial responders. Br J Haematol 98:983-991, 1997
33. DeWitte T, Suciu S, Peetermans M, et al: Intensive chemotherapy for poor prognosis myelodysplasia (MDS) and secondary acute myeloid leukemia (sAML) following MDS of more than 6 months duration: A pilot study by the Leukemia Cooperative Group of the European Organisation for Research and Treatment in Cancer (EORTC-LCG). Leukemia 9:1805-1811, 1995
34. Parker JE, Pagliuca A, Mijovic A, et al: Fludarabine, cytarabine, G-CSF and idarubicin (FLAG-IDA) for the treatment of poor-risk myelodysplastic syndromes and acute myeloid leukaemia. Br J Haematol 99:939-944, 1997
35. Invernizzi R, Pecci A, Rossi G, et al: Idarubicin and cytosine arabinoside in the induction and maintenance therapy of high-risk myelodysplastic syndromes. Haematologica 82:9-12, 1997
36. Economopoulos T, Papageorgiou E, Stathakis N, et al: Treatment of high risk myelodysplastic syndromes with idarubicin and cytosine arabinoside supported by granulocyte-macrophage colony-stimulating factor (GM-CSF). Leuk Lymphoma 20:385-391, 1996
37. Ruutu T, Hänninen A, Järventie G, et al: Intensive chemotherapy of poor prognosis myelodysplastic syndromes (MDS) and acute myeloid leukemia following MDS with idarubicin and cytarabine. Leuk Res 21:133-138, 1997
38. Fenaux P, Morel P, Rose C, et al: Prognostic factors in adult de novo myelodysplastic syndromes treated by intensive chemotherapy. Br J Haematol 77:497-501, 1991
39. Hsiang Y-H, Liu LF: Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res 48:1722-1726, 1988
40. Hsiang Y-H, Lihou MG, Liu LF: Arrest of replication forks by drug-stabilized topoisomerase I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res 49:5077-5082, 1989
41. Zhang H, D'Arpa P, Liu LF: A model for tumor cell killing by topoisomerase poisons. Cancer Cells 2:23-27, 1990
42. Hochsler HS: Topotecan clinical trials in the United States, in Potmesil M, Pinedo H (eds): Camptothecins: New Anticancer Agents. Boca Raton, FL, CRC Press, 1995, pp 93-104
43. Verweig J, Sokkel Heriming W, Lung B, et al: Clinical trials of topotecan in Europe, in Potmesil M, Pinedo H (eds): Camptothecins: New Anticancer Agents. Boca Raton, FL, CRC Press, 1995, pp 105-112
44. Kantarjian HM, Beran M, Ellis A, et al: Phase I study of topotecan, a new topoisomerase I inhibitor in patients with refractory or relapsed acute leukemia. Blood 81:1146-1151, 1993
45. Rowinsky EK, Adjei A, Donehower RC, et al: Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol 12:2193-2203, 1994
46. Rowinsky EK, Kaufmann SH, Baker SD, et al: A phase I and pharmacological study of topotecan infused over 30 minutes for five days in patients with refractory acute leukemia. Clin Cancer Res 2:1921-1930, 1996
47. Beran M, Kantarjian HM, O'Brien S, et al: Topotecan, a topoisomerase I inhibitor, is active in the treatment of myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood 88:2473-2479, 1996
48. Beran M, Estey E, O'Brien S, et al: Results of topotecan single-agent therapy in patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. Leuk Lymphoma 31:521-531, 1998
49. Ghaddar HM, Plunkett W, Kantarjian HM, et al: Long-term results following treatment of newly-diagnosed acute myelogenous leukemia with continuous-infusion high-dose cytosine arabinoside. Leukemia 8:1269-1274, 1994
50. Estey E, Beran M, Pierce S, et al: All-trans retinoic acid (ATRA) may improve results of chemotherapy in poor prognosis non-APLAML and MDS: A randomized study. Blood 90:416, 1997 (abstr 1851)
51. Estey E, Thall PF, Pierce S, et al: Randomized phase II study of fludarabine + cytosine arabinoside + idarubicin +/- all-trans retinoic acid +/- granulocyte colony-stimulating factor in poor prognosis newly diagnosed acute myeloid leukemia and myelodysplastic syndrome. Blood 93:2478-2484, 1999
52. 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 and myelodysplastic syndromes: Comparison with fludarabine plus cytarabine without granulocyte colony-stimulating factor. J Clin Oncol 12:671-678, 1994
53. Estey E, Kantarjian HM, O'Brien S, et al: High remission rate, short remission duration in patients with refractory anemia with excess blasts (RAEB) in transformation (RAEB-t) given acute myelogenous leukemia (AML)-type chemotherapy in combination with granulocyteCSF (G-CFS). Cytokines Mol Ther 1:21-28, 1995
54. National Cancer Institute: Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD, Division of Cancer Treatment, National Cancer Institute, 1988
55. Crump M, Lipton J, Hedley D, et al: A phase I trial of sequential topotecan and etoposide in adult acute myeloid leukemia (AML). Blood 88:867, 1996 (abstr 867)
56. Cooper BW, Lazarus HM, Creger R, et al: A phase I and pharmacodynamic study of sequential topotecan and etoposide (TE) in adult patients with refractory relapsed acute leukemia (RAL). J Clin Oncol 15:486, 1996 (abstr 486)
57. Rowinsky EK, Kaufmann SK: Topotecan in combination chemotherapy. Semin Oncol 24:S20-S26, 1997 (suppl 20)
58. Seiter K, Feldman EJ, Halicka D, et al: Phase I clinical and laboratory evaluation of topotecan and cytarabine in patients with acute leukemia. J Clin Oncol 15:44-51, 1997
59. Keating MJ, Smith TL, Gehan EA, et al: A prognostic factor analysis for use in development of predictive models for response in adult acute leukemia. Cancer 50:457-465, 1982
60. Preisler HD, Early A, Raza A, et al: Therapy of secondary acute nonlymphocytic leukemia with cytarabine. N Engl J Med 308:21-24, 1983