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Published in: Annals of Hematology 1/2005

01-12-2005 | Original Article

Quantification of outpatient management and hospitalization of patients with high-risk myelodysplastic syndrome treated with low-dose decitabine

Authors: J. A. Pitako, P. S. Haas, J. Van den Bosch, H. Müller-Berndorff, A. Kündgen, U. Germing, P. W. Wijermans, M. Lübbert

Published in: Annals of Hematology | Special Issue 1/2005

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Abstract

Intravenous low-dose 5-aza-2′-deoxycytidine (decitabine) in patients with advanced myelodysplastic syndrome (MDS) yields an approximately 50% overall response rate, including 20–25% complete remission. Decitabine-treated MDS patients can be managed as outpatients after completion of a 3-day infusion schedule. In-hospital nights (IHNs), overall survival (OS), and remaining life spent in hospital were evaluated and compared to a matched control group receiving different standard treatments. Between July 1992 and September 2001, 99 high-risk MDS patients, median age 70 years (range 49–86), were treated with low-dose decitabine. Durations of all hospitalizations were recorded. For matched-pair analysis, 44 decitabine-treated patients were matched to 44 MDS patients according to International Prognostic Scoring System classification, period of diagnosis, age, French–American–British classification, and gender. Median number of IHN across all patients was 56 and survival was 481 days, resulting in 84% of remaining life spent at home. In the matched-pair analysis, the median number of IHN was 57 in the decitabine group vs. 50 in the control group. Median survival was 400 vs. 371 days for the decitabine and control groups, respectively. Median number of remaining life spent at home was identical (83% for both groups). Matched patients who received only best supportive care (n=12) had a shorter median survival than the decitabine patients (234 vs. 400 days), and the proportion of remaining life spent at home was slightly greater (82 vs. 77%). Interestingly, matched patients with induction therapy showed comparable IHN, OS, and remaining life spent at home. In conclusion, high-risk MDS patients treated with low-dose decitabine have better survival, and spend comparable time in hospital than patients treated with supportive treatment.
Literature
1.
go back to reference Altman DG, De Stavola BL, Love SB, Stepniewska KA (1995) Review of survival analyses published in cancer journals. Br J Cancer 72:511–518PubMed Altman DG, De Stavola BL, Love SB, Stepniewska KA (1995) Review of survival analyses published in cancer journals. Br J Cancer 72:511–518PubMed
2.
go back to reference Aul C, Germing U, Gattermann N, Sohngen D, Heyll A (1996) The prognostic significance of serum thymidine kinase in the myelodysplastic syndrome. Dtsch Med Wochenschr 121:1113–1118PubMedCrossRef Aul C, Germing U, Gattermann N, Sohngen D, Heyll A (1996) The prognostic significance of serum thymidine kinase in the myelodysplastic syndrome. Dtsch Med Wochenschr 121:1113–1118PubMedCrossRef
3.
go back to reference Baldi G, D’Inca M, Saltini L, Zanoni P, Ghirarduzzi A, Gobbi F (1993) Cost/benefit relationship in 46 cases of myelodysplastic syndrome (RAEB and RAEB-T): a quality assurance analysis in clinical haematology. Haematologica 78:291–296PubMed Baldi G, D’Inca M, Saltini L, Zanoni P, Ghirarduzzi A, Gobbi F (1993) Cost/benefit relationship in 46 cases of myelodysplastic syndrome (RAEB and RAEB-T): a quality assurance analysis in clinical haematology. Haematologica 78:291–296PubMed
4.
go back to reference Bender CM, Pao MM, Jones PA (1998) Inhibition of DNA methylation by 5-aza-2′-deoxycytidine suppresses the growth of human tumor cell lines. Cancer Res 58:95–101PubMed Bender CM, Pao MM, Jones PA (1998) Inhibition of DNA methylation by 5-aza-2′-deoxycytidine suppresses the growth of human tumor cell lines. Cancer Res 58:95–101PubMed
5.
go back to reference Cheson BD, Jasperse DM, Simon R, Friedman MA (1986) A critical appraisal of low-dose cytosine arabinoside in patients with acute non-lymphocytic leukemia and myelodysplastic syndromes. J Clin Oncol 4:1857–1864PubMed Cheson BD, Jasperse DM, Simon R, Friedman MA (1986) A critical appraisal of low-dose cytosine arabinoside in patients with acute non-lymphocytic leukemia and myelodysplastic syndromes. J Clin Oncol 4:1857–1864PubMed
6.
go back to reference Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL (2000) World Health Organization (WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 96:3671–3674PubMed Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL (2000) World Health Organization (WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 96:3671–3674PubMed
7.
go back to reference Estey EH, Thall PF, Pierce S, Cortes J, Beran M, Kantarjian H, Keating MJ, Andreeff M, Freireich E (1999) 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 93:2478–2484PubMed Estey EH, Thall PF, Pierce S, Cortes J, Beran M, Kantarjian H, Keating MJ, Andreeff M, Freireich E (1999) 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 93:2478–2484PubMed
8.
go back to reference Gillis S, Dann EJ, Rund D (1996) Selective discharge of patients with acute myeloid leukemia during chemotherapy-induced neutropenia. Am J Hematol 51:26–31CrossRefPubMed Gillis S, Dann EJ, Rund D (1996) Selective discharge of patients with acute myeloid leukemia during chemotherapy-induced neutropenia. Am J Hematol 51:26–31CrossRefPubMed
9.
go back to reference Jones PA, Taylor SM (1980) Cellular differentiation, cytidine analogs and DNA methylation. Cell 20:85–93CrossRefPubMed Jones PA, Taylor SM (1980) Cellular differentiation, cytidine analogs and DNA methylation. Cell 20:85–93CrossRefPubMed
10.
go back to reference Konstantopoulos K, Lauren L, Hast R, Reizenstein P (1998) Survival, hospitalization and cause of death in 99 patients with myelodysplastic syndrome. Anticancer Res 9:893–896 Konstantopoulos K, Lauren L, Hast R, Reizenstein P (1998) Survival, hospitalization and cause of death in 99 patients with myelodysplastic syndrome. Anticancer Res 9:893–896
11.
go back to reference Kurzrock R, Estey E, Talpaz M (1993) All-trans retinoic acid: tolerance and biologic effects in myelodysplastic syndrome. J Clin Oncol 11:1489–1495PubMed Kurzrock R, Estey E, Talpaz M (1993) All-trans retinoic acid: tolerance and biologic effects in myelodysplastic syndrome. J Clin Oncol 11:1489–1495PubMed
12.
go back to reference Löwenberg B, Zittoun R, Kerkhofs H, Jehn U, Abels J, Debusscher L, Cauchie C, Peetermans M, Solbu G, Suciu S (1989) 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 7:1268–1274PubMed Löwenberg B, Zittoun R, Kerkhofs H, Jehn U, Abels J, Debusscher L, Cauchie C, Peetermans M, Solbu G, Suciu S (1989) 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 7:1268–1274PubMed
13.
go back to reference Lübbert M, Wijermans P, Kunzmann R, Verhoef G, Bosly A, Ravoet C, Andre M, Ferrant A (2001) Cytogenetic responses in high-risk myelodysplastic syndrome following low-dose treatment with the DNA methylation inhibitor 5-aza-2′-deoxycytidine. Br J Haematol 114:349–357CrossRefPubMed Lübbert M, Wijermans P, Kunzmann R, Verhoef G, Bosly A, Ravoet C, Andre M, Ferrant A (2001) Cytogenetic responses in high-risk myelodysplastic syndrome following low-dose treatment with the DNA methylation inhibitor 5-aza-2′-deoxycytidine. Br J Haematol 114:349–357CrossRefPubMed
14.
go back to reference Menzin J, Lang K, Earle CC, Kerney D, Mallick R (2002) The outcomes and costs of acute myeloid leukemia among the elderly. Arch Intern Med 162:1597–1603CrossRefPubMed Menzin J, Lang K, Earle CC, Kerney D, Mallick R (2002) The outcomes and costs of acute myeloid leukemia among the elderly. Arch Intern Med 162:1597–1603CrossRefPubMed
15.
go back to reference Pulsoni A, Pagano L, Latagliata R, Casini M, Cerri R, Crugnola M, De Paoli L, Di Bona E, Invernizzi R, Marmont F, Concetta Petti M, Rigolin G, Ronco F, Spadano A, Tosti ME, Visani G, Mele A, Mandelli F (2004) Survival of elderly patients with acute myeloid leukemia. Haematologica 89:296–302PubMed Pulsoni A, Pagano L, Latagliata R, Casini M, Cerri R, Crugnola M, De Paoli L, Di Bona E, Invernizzi R, Marmont F, Concetta Petti M, Rigolin G, Ronco F, Spadano A, Tosti ME, Visani G, Mele A, Mandelli F (2004) Survival of elderly patients with acute myeloid leukemia. Haematologica 89:296–302PubMed
16.
go back to reference Saba H, Rosenfeld C, Issa JP et al (2004) First report of phase III North American trial of decitabine in advanced myelodysplastic syndrome (MDS). Blood 104:23a, abstract 67 Saba H, Rosenfeld C, Issa JP et al (2004) First report of phase III North American trial of decitabine in advanced myelodysplastic syndrome (MDS). Blood 104:23a, abstract 67
17.
go back to reference Sekeres MA, Stone RM, Zahrieh D, Neuberg D, Morrison V, De Angelo DJ, Galinsky I, Lee SJ (2004) Treatment, decision-making and quality of life in older adults with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (aMDS). Leukemia 18:809–816CrossRefPubMed Sekeres MA, Stone RM, Zahrieh D, Neuberg D, Morrison V, De Angelo DJ, Galinsky I, Lee SJ (2004) Treatment, decision-making and quality of life in older adults with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (aMDS). Leukemia 18:809–816CrossRefPubMed
18.
go back to reference Thomas ML (1998) Quality of life and psychosocial adjustment in patients with myelodysplastic syndromes. Leuk Res 22:41–47CrossRef Thomas ML (1998) Quality of life and psychosocial adjustment in patients with myelodysplastic syndromes. Leuk Res 22:41–47CrossRef
19.
go back to reference Uberti JP, Ratanatharathorn V, Karanes C, Sensenbrenner LL (1994) Allogeneic bone marrow transplantation in patients with myelodysplastic syndromes. Leuk Lymphoma 14:379–385PubMedCrossRef Uberti JP, Ratanatharathorn V, Karanes C, Sensenbrenner LL (1994) Allogeneic bone marrow transplantation in patients with myelodysplastic syndromes. Leuk Lymphoma 14:379–385PubMedCrossRef
20.
go back to reference Westermann AM, Holtkamp MM, Linthorst GA, van Leeuwen L, Willemse EJ, van Dijk WC, Nooijen WJ, Baars JW, Schornagel JH, Rodenhuis S (1999) At home management of aplastic phase following high-dose chemotherapy with stem-cell rescue for hematological and non-hematological malignancies. Ann Oncol 10:511–517CrossRefPubMed Westermann AM, Holtkamp MM, Linthorst GA, van Leeuwen L, Willemse EJ, van Dijk WC, Nooijen WJ, Baars JW, Schornagel JH, Rodenhuis S (1999) At home management of aplastic phase following high-dose chemotherapy with stem-cell rescue for hematological and non-hematological malignancies. Ann Oncol 10:511–517CrossRefPubMed
21.
go back to reference Wijermans P, Lübbert M, Verhoef G, Bosly A, Ravoet C, Andre M, Ferrant A (2000) Low-dose 5-Aza-2′-Deoxycytidine, a DNA hypomethylating agent for treatment of high-risk myelodysplastic syndrome: a multicenter phase II study in elderly patients. J Clin Oncol 18:956–962PubMed Wijermans P, Lübbert M, Verhoef G, Bosly A, Ravoet C, Andre M, Ferrant A (2000) Low-dose 5-Aza-2′-Deoxycytidine, a DNA hypomethylating agent for treatment of high-risk myelodysplastic syndrome: a multicenter phase II study in elderly patients. J Clin Oncol 18:956–962PubMed
Metadata
Title
Quantification of outpatient management and hospitalization of patients with high-risk myelodysplastic syndrome treated with low-dose decitabine
Authors
J. A. Pitako
P. S. Haas
J. Van den Bosch
H. Müller-Berndorff
A. Kündgen
U. Germing
P. W. Wijermans
M. Lübbert
Publication date
01-12-2005
Publisher
Springer-Verlag
Published in
Annals of Hematology / Issue Special Issue 1/2005
Print ISSN: 0939-5555
Electronic ISSN: 1432-0584
DOI
https://doi.org/10.1007/s00277-005-0007-y

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