Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome: Comparison with historical experience

Hagop M. Kantarjian, Susan O'Brien, Xuelin Huang, Guillermo Garcia-Manero, Farhad Ravandi, Jorge Cortes, Jianqin Shan, Jan Davisson, Carlos E. Bueso-Ramos, Jean Pierre Issa

Research output: Contribution to journalArticle

Abstract

BACKGROUND. Decitabine, a hypomethylating agent, is active and has been approved for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Intensive chemotherapy is an accepted form of therapy for patients with higher risk MDS. The comparative efficacy of these 2 forms of treatment in MDS is unknown. The objective of the current study was to compare the efficacy and toxicity profiles of decitabine and intensive chemotherapy in MDS. METHODS. The authors compared lower intensity decitabine therapy (n = 115 patients) with intensive chemotherapy (as it is used in acute myeloid leukemia [AML]) in patients with higher risk MDS. Two comparisons were made with a cohort of 376 historic patients (from 1995 to 2005): The first comparison included a subcohort of 115 patients (Group A) who matched the 115 decitabine study patients according to age, International Prognostic Scoring System, and cytogenetics; and the second comparison included the whole cohort of 376 patients without matching (Group B). A multivariate analysis was performed for outcome. RESULTS. The complete remission (CR) rate according to AML criteria was 43% with decitabine, 46% with intensive chemotherapy in Group A, and 52% with intensive chemotherapy in Group B. Compared with Group A, mortality at 6 weeks was 3% with decitabine versus 13% with intensive chemotherapy (P = .006) and, at 3 months, 7% with decitabine versus 23% with intensive chemotherapy (P = .001). Survival was better with decitabine versus intensive chemotherapy in Group A (median survival: 22 months vs 12 months; P < .001). A multivariate analysis of survival in all 491 patients who received decitabine or intensive chemotherapy (Group B) selected decitabine as an independent, favorable prognostic factor for survival (P = .006; hazard ratio, 0.74) after accounting for the independent prognostic effect of pretreatment factors. CONCLUSIONS. In this analysis, decitabine was associated with a survival advantage compared with intensive chemotherapy in patients with higher risk MDS. Future studies should evaluate prospectively the results of decitabine versus intensive chemotherapy in this setting.

Original languageEnglish (US)
Pages (from-to)1133-1137
Number of pages5
JournalCancer
Volume109
Issue number6
DOIs
StatePublished - Mar 15 2007
Externally publishedYes

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decitabine
Myelodysplastic Syndromes
Drug Therapy
Survival
Acute Myeloid Leukemia
Multivariate Analysis
Leukemia, Myelomonocytic, Chronic

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome : Comparison with historical experience. / Kantarjian, Hagop M.; O'Brien, Susan; Huang, Xuelin; Garcia-Manero, Guillermo; Ravandi, Farhad; Cortes, Jorge; Shan, Jianqin; Davisson, Jan; Bueso-Ramos, Carlos E.; Issa, Jean Pierre.

In: Cancer, Vol. 109, No. 6, 15.03.2007, p. 1133-1137.

Research output: Contribution to journalArticle

Kantarjian, HM, O'Brien, S, Huang, X, Garcia-Manero, G, Ravandi, F, Cortes, J, Shan, J, Davisson, J, Bueso-Ramos, CE & Issa, JP 2007, 'Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome: Comparison with historical experience', Cancer, vol. 109, no. 6, pp. 1133-1137. https://doi.org/10.1002/cncr.22508
Kantarjian, Hagop M. ; O'Brien, Susan ; Huang, Xuelin ; Garcia-Manero, Guillermo ; Ravandi, Farhad ; Cortes, Jorge ; Shan, Jianqin ; Davisson, Jan ; Bueso-Ramos, Carlos E. ; Issa, Jean Pierre. / Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome : Comparison with historical experience. In: Cancer. 2007 ; Vol. 109, No. 6. pp. 1133-1137.
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title = "Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome: Comparison with historical experience",
abstract = "BACKGROUND. Decitabine, a hypomethylating agent, is active and has been approved for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Intensive chemotherapy is an accepted form of therapy for patients with higher risk MDS. The comparative efficacy of these 2 forms of treatment in MDS is unknown. The objective of the current study was to compare the efficacy and toxicity profiles of decitabine and intensive chemotherapy in MDS. METHODS. The authors compared lower intensity decitabine therapy (n = 115 patients) with intensive chemotherapy (as it is used in acute myeloid leukemia [AML]) in patients with higher risk MDS. Two comparisons were made with a cohort of 376 historic patients (from 1995 to 2005): The first comparison included a subcohort of 115 patients (Group A) who matched the 115 decitabine study patients according to age, International Prognostic Scoring System, and cytogenetics; and the second comparison included the whole cohort of 376 patients without matching (Group B). A multivariate analysis was performed for outcome. RESULTS. The complete remission (CR) rate according to AML criteria was 43{\%} with decitabine, 46{\%} with intensive chemotherapy in Group A, and 52{\%} with intensive chemotherapy in Group B. Compared with Group A, mortality at 6 weeks was 3{\%} with decitabine versus 13{\%} with intensive chemotherapy (P = .006) and, at 3 months, 7{\%} with decitabine versus 23{\%} with intensive chemotherapy (P = .001). Survival was better with decitabine versus intensive chemotherapy in Group A (median survival: 22 months vs 12 months; P < .001). A multivariate analysis of survival in all 491 patients who received decitabine or intensive chemotherapy (Group B) selected decitabine as an independent, favorable prognostic factor for survival (P = .006; hazard ratio, 0.74) after accounting for the independent prognostic effect of pretreatment factors. CONCLUSIONS. In this analysis, decitabine was associated with a survival advantage compared with intensive chemotherapy in patients with higher risk MDS. Future studies should evaluate prospectively the results of decitabine versus intensive chemotherapy in this setting.",
author = "Kantarjian, {Hagop M.} and Susan O'Brien and Xuelin Huang and Guillermo Garcia-Manero and Farhad Ravandi and Jorge Cortes and Jianqin Shan and Jan Davisson and Bueso-Ramos, {Carlos E.} and Issa, {Jean Pierre}",
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T1 - Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome

T2 - Comparison with historical experience

AU - Kantarjian, Hagop M.

AU - O'Brien, Susan

AU - Huang, Xuelin

AU - Garcia-Manero, Guillermo

AU - Ravandi, Farhad

AU - Cortes, Jorge

AU - Shan, Jianqin

AU - Davisson, Jan

AU - Bueso-Ramos, Carlos E.

AU - Issa, Jean Pierre

PY - 2007/3/15

Y1 - 2007/3/15

N2 - BACKGROUND. Decitabine, a hypomethylating agent, is active and has been approved for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Intensive chemotherapy is an accepted form of therapy for patients with higher risk MDS. The comparative efficacy of these 2 forms of treatment in MDS is unknown. The objective of the current study was to compare the efficacy and toxicity profiles of decitabine and intensive chemotherapy in MDS. METHODS. The authors compared lower intensity decitabine therapy (n = 115 patients) with intensive chemotherapy (as it is used in acute myeloid leukemia [AML]) in patients with higher risk MDS. Two comparisons were made with a cohort of 376 historic patients (from 1995 to 2005): The first comparison included a subcohort of 115 patients (Group A) who matched the 115 decitabine study patients according to age, International Prognostic Scoring System, and cytogenetics; and the second comparison included the whole cohort of 376 patients without matching (Group B). A multivariate analysis was performed for outcome. RESULTS. The complete remission (CR) rate according to AML criteria was 43% with decitabine, 46% with intensive chemotherapy in Group A, and 52% with intensive chemotherapy in Group B. Compared with Group A, mortality at 6 weeks was 3% with decitabine versus 13% with intensive chemotherapy (P = .006) and, at 3 months, 7% with decitabine versus 23% with intensive chemotherapy (P = .001). Survival was better with decitabine versus intensive chemotherapy in Group A (median survival: 22 months vs 12 months; P < .001). A multivariate analysis of survival in all 491 patients who received decitabine or intensive chemotherapy (Group B) selected decitabine as an independent, favorable prognostic factor for survival (P = .006; hazard ratio, 0.74) after accounting for the independent prognostic effect of pretreatment factors. CONCLUSIONS. In this analysis, decitabine was associated with a survival advantage compared with intensive chemotherapy in patients with higher risk MDS. Future studies should evaluate prospectively the results of decitabine versus intensive chemotherapy in this setting.

AB - BACKGROUND. Decitabine, a hypomethylating agent, is active and has been approved for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Intensive chemotherapy is an accepted form of therapy for patients with higher risk MDS. The comparative efficacy of these 2 forms of treatment in MDS is unknown. The objective of the current study was to compare the efficacy and toxicity profiles of decitabine and intensive chemotherapy in MDS. METHODS. The authors compared lower intensity decitabine therapy (n = 115 patients) with intensive chemotherapy (as it is used in acute myeloid leukemia [AML]) in patients with higher risk MDS. Two comparisons were made with a cohort of 376 historic patients (from 1995 to 2005): The first comparison included a subcohort of 115 patients (Group A) who matched the 115 decitabine study patients according to age, International Prognostic Scoring System, and cytogenetics; and the second comparison included the whole cohort of 376 patients without matching (Group B). A multivariate analysis was performed for outcome. RESULTS. The complete remission (CR) rate according to AML criteria was 43% with decitabine, 46% with intensive chemotherapy in Group A, and 52% with intensive chemotherapy in Group B. Compared with Group A, mortality at 6 weeks was 3% with decitabine versus 13% with intensive chemotherapy (P = .006) and, at 3 months, 7% with decitabine versus 23% with intensive chemotherapy (P = .001). Survival was better with decitabine versus intensive chemotherapy in Group A (median survival: 22 months vs 12 months; P < .001). A multivariate analysis of survival in all 491 patients who received decitabine or intensive chemotherapy (Group B) selected decitabine as an independent, favorable prognostic factor for survival (P = .006; hazard ratio, 0.74) after accounting for the independent prognostic effect of pretreatment factors. CONCLUSIONS. In this analysis, decitabine was associated with a survival advantage compared with intensive chemotherapy in patients with higher risk MDS. Future studies should evaluate prospectively the results of decitabine versus intensive chemotherapy in this setting.

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