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Clinical Trial
. 2012 Sep 15;118(18):4471-7.
doi: 10.1002/cncr.27429. Epub 2012 Jan 26.

Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients

Stefan Faderl  1 , Farhad Ravandi, Xuelin Huang, Xuemei Wang, Elias Jabbour, Guillermo Garcia-Manero, Tapan Kadia, Alessandra Ferrajoli, Marina Konopleva, Gautam Borthakur, Jan Burger, Jennie Feliu, Hagop M Kantarjian
Affiliations
Clinical Trial

Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients

Stefan Faderl et al. Cancer. .

Abstract

Background: Standard therapy for older patients with acute myeloid leukemia (AML) has a poor outcome. The authors have designed a combination of clofarabine plus low-dose cytarabine followed by a prolonged consolidation alternating with decitabine.

Methods: Sixty patients with a median age of 70 years (range, 60-81 years) with newly diagnosed AML were included. They received clofarabine 20 mg/m(2) intravenously daily for 5 days plus cytarabine 20 mg subcutaneously twice daily for 10 days. Responding patients continued for up to 17 courses of consolidation therapy including decitabine.

Results: Forty of 59 evaluable patients responded (66%). Complete remission rate was 58%. Median relapse-free survival (RFS) was 14.1 (95% confidence interval [CI], 6.9 to not estimable), and median overall survival (OS) was 12.7 months (95% CI, 8.8 to not estimable). Median OS of responding patients (complete response [CR]/CR with platelet count <100 × 109/L) was 24.2 months (95% CI, 17 to not estimable). Compared with a historical group of patients who received clofarabine plus low-dose cytarabine with a shorter consolidation, RFS was not statistically different. Induction mortality was low (7% at 8 weeks) and toxicities manageable.

Conclusions: Clofarabine plus low-dose cytarabine alternating with decitabine in consolidation is active in older patients with newly diagnosed AML. The benefits of a prolonged consolidation remain unproven.

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Figures

Figure 1
Figure 1
Treatment flow diagram
Figure 2
Figure 2
Kaplan-Meier estimates for OS by response status
Figure 3
Figure 3
Kaplan-Meier estimates for RFS
Figure 4
Figure 4
Kaplan-Meier estimates for OS
See this image and copyright information in PMC

References

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    1. Kantarjian HM, Erba HP, Claxton D, et al. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010;28:549–555. - PubMed
    1. Burnett AK, Russell NH, Kell J, et al. European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy. J Clin Oncol. 2010;28:2389–2395. - PubMed

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