A comparison of clofarabine with Ara-C, each in combination with daunorubicin as induction treatment in older patients with acute myeloid leukaemia.


Burnett, AK, Russell, NH, Hills, RK, Kell, J, Nielsen, OJ, Dennis, M, Cahalin, P, Pocock, C, Ali, S, Burns, S et al (show 3 more authors) (2017) A comparison of clofarabine with Ara-C, each in combination with daunorubicin as induction treatment in older patients with acute myeloid leukaemia. Leukemia, 31 (2). pp. 310-317.

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Abstract

The study was designed to compare clofarabine plus daunorubicin versus daunorubicin/ara-C in older patients with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS). Eight hundred and six untreated patients in the UK NCRI AML16 trial with AML/high-risk MDS (median age, 67yrs; range 56-84) and normal serum creatinine were randomised to two courses of induction chemotherapy with either daunorubicin/ara-C (DA) or daunorubicin/clofarabine (DClo). Patients were also included in additional randomisations; +/- one dose of gemtuzumab ozogamicin in course 1; 2v3 courses and +/- azacitidine maintenance. The primary endpoint was overall survival. The overall response rate was 69% (CR 60%; CRi 9%), with no difference between DA (71%) and DClo (66%). There was no difference in 30-/60-day mortality or toxicity: significantly more supportive care was required in the DA arm even though platelet and neutrophil recovery was significantly slower with DClo. There were no differences in cumulative incidence of relapse (74 vs 68%;HR 0.93 (0.77-1.14),P=0.5); survival from relapse (7 vs 9%;HR 0.96 (0.77-1.19),P=0.7); relapse-free (31 vs 32%; HR 1.02 (0.83-1.24),P=0.9) or overall survival (23 vs 22%; HR 1.08 (0.93-1.26),P=0.3). Clofarabine 20 mg/m(2) given for 5 days with daunorubicin is not superior to ara-C+daunorubicin as induction for older patients with AML/high risk MDS.Leukemia accepted article preview online, 02 September 2016. doi:10.1038/leu.2016.225.

Item Type: Article
Uncontrolled Keywords: Humans, Recurrence, Daunorubicin, Arabinonucleosides, Cytarabine, Adenine Nucleotides, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Cause of Death, Survival Analysis, Age Factors, Aged, Aged, 80 and over, Middle Aged, Female, Male, Leukemia, Myeloid, Acute, Induction Chemotherapy, Clofarabine
Depositing User: Symplectic Admin
Date Deposited: 26 Oct 2016 15:57
Last Modified: 19 Jan 2023 07:27
DOI: 10.1038/leu.2016.225
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3004140
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