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Therapy

Low-dose cytarabine maintenance therapy vs observation after remission induction in advanced acute myeloid leukemia: an Eastern Cooperative Oncology Group Trial (E5483)

Leukemia volume 14, pages 1349–1353 (2000)Cite this article

Abstract

The Eastern Cooperative Oncology Group (ECOG) conducted a prospective phase III study in patients with relapsed/refractory acute myeloid leukemia (AML) to evaluate whether administration of repeated courses of low-dose cytarabine (LDAC) maintenance therapy after induction of complete remission in advanced AML would improve disease-free and overall survival. Patients with AML in second/later relapse or refractory disease were first treated with a combination of high-dose cytarabine and amsacrine. Those who achieved complete remission were then randomized to observation or to receive LDAC, 10 mg/m2subcutaneously twice a day ×2 21 days every 2 months until relapse occurred. Of 86 patients eligible for randomization, 41 patients were assigned to receive LDAC and 45 patients to observation. The median disease-free survival was 7.4 months for patients assigned to LDAC compared to 3.3 months for patients receiving no additional therapy, P = 0.084. The median survival from randomization was 10.9 months and 7.0 months for patients receiving LDAC maintenance chemotherapy and observation, respectively (P = 0.615). The data from this study suggest that LDAC maintenance therapy given to patients with advanced AML who achieve complete remission can increase disease-free survival compared to observation, but does not improve overall survival. Nevertheless, because of the ineffectiveness and toxicity of intensive post-remission chemotherapy in this circumstance, LDAC maintenance therapy, a tolerable outpatient regimen, offers the potential for improved quality of life.

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Acknowledgements

This study was conducted by the Eastern Cooperative Oncology Group (Robert L Comis, MD, Chair) and supported by Public Health Service grants CA23318, CA11083, CA13650, CA14958, CA66636, and CA21115 from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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Authors and Affiliations

  1. University of Miami School of Medicine, Miami, FL, USA

    C Robles & PA Cassileth

  2. Dana Farber Cancer Institute, Boston, MA, USA

    KM Kim

  3. Virginia Piper Cancer Institute, Minneapolis, MN, USA

    MM Oken

  4. University of Rochester, Rochester, NY, USA

    JM Bennett

  5. Mayo Clinic, Rochester, MN, USA

    L Letendre & MJ O'Connell

  6. Albert Einstein College of Medicine, Bronx, NY, USA

    PH Wiernik

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  1. C Robles
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Robles, C., Kim, K., Oken, M. et al. Low-dose cytarabine maintenance therapy vs observation after remission induction in advanced acute myeloid leukemia: an Eastern Cooperative Oncology Group Trial (E5483). Leukemia 14, 1349–1353 (2000). https://doi.org/10.1038/sj.leu.2401850

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