Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2007 Mar 15;109(6):1133-7.
doi: 10.1002/cncr.22508.

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

Hagop M Kantarjian  1 , Susan O'Brien, Xuelin Huang, Guillermo Garcia-Manero, Farhad Ravandi, Jorge Cortes, Jianqin Shan, Jan Davisson, Carlos E Bueso-Ramos, Jean-Pierre Issa
Affiliations
Randomized Controlled Trial

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

Hagop M Kantarjian et al. Cancer. .

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.

PubMed Disclaimer

Figures

FIGURE 1
FIGURE 1
Survival with decitabine versus a matched historic intensive chemotherapy group (A) and the total historic intensive chemotherapy group (B).
FIGURE 2
FIGURE 2
Survival with decitabine versus total the historic control group by age ≥60 years (A) and age <60 years (B).
See this image and copyright information in PMC

References

    1. Faderl S, Kantarjian H. Novel therapies for myelodysplastic syndromes. Cancer. 2004;101:226–241. - PubMed
    1. Faderl S, Kantarjian H. Myelodysplastic syndromes. In: DeVita V, Hellman S, Rosenberg S, editors. Cancer: Principles and Practice of Oncology. 7th. Philadelphia, PA: Lippincott Williams & Wilkins; 2005. pp. 2144–2154.
    1. Bennett JM, Catovsky D, Daniel MT, et al. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982;51:189–199. - PubMed
    1. Harris NJ, Jaffe ES, Diebold J, et al. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting, Airlie House, Virginia, November 1977. J Clin Oncol. 1999;17:3835–3849. - PubMed
    1. Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997;89:2079–2088. - PubMed

Publication types

MeSH terms