The addition of arsenic trioxide to low-dose Ara-C in older patients with AML does not improve outcome

A.K. Burnett, R.K. Hills, A. Hunter, D. Milligan, Ruth Kell, K. Wheatley, J. Yin, Mary Frances McMullin, P. Cahalin, J. Craig, D. Bowen, N. Russell

Research output: Contribution to journalArticlepeer-review

28 Citations (Scopus)

Abstract

Most patients with acute myeloid leukaemia (AML) are older, with many unsuitable for conventional chemotherapy. Low-dose Ara-C (LDAC) is superior to best supportive care but is still inadequate. The combination of arsenic trioxide (ATO) and LDAC showed promise in an unrandomised study. We report a randomised trial of LDAC versus LDAC + ATO. Patients with AML according to WHO criteria or myelodysplastic syndrome with > 10% blasts, considered as unfit for conventional chemotherapy, were randomised between subcutaneous Ara-C (20mg b.d. for 10 days) and the same LDAC schedule with ATO (0.25 mg/kg) on days 1-5, 9 and 11, for at least four courses every 4 to 6 weeks. Overall 166 patients were entered; the trial was terminated on the advice of the DMC, as the projected benefit was not observed. Overall 14% of patients achieved complete remission (CR) and 7% CRi. Median survival was 5.5 months and 19 months for responders (CR: not reached; CRi: 14 months; non-responders: 4 months). There were no differences in response or survival between the arms. Grade 3/4 cardiac and liver toxicity, and supportive care requirements were greater in the ATO arm. This randomised comparison demonstrates that adding ATO to LDAC provides no benefit for older patients with AML. Leukemia (2011) 25, 1122-1127; doi:10.1038/leu.2011.59; published online 8 April 2011
Original languageEnglish
Pages (from-to)1122-1127
Number of pages6
JournalLeukemia
Volume25
Issue number7
DOIs
Publication statusPublished - Jul 2011

Keywords

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Arsenicals
  • Comorbidity
  • Cytarabine
  • Disease-Free Survival
  • Drug-Induced Liver Injury
  • Early Termination of Clinical Trials
  • Female
  • Gastrointestinal Diseases
  • Heart Diseases
  • Humans
  • Kaplan-Meier Estimate
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Acute
  • Male
  • Middle Aged
  • Oxides
  • Remission Induction
  • Treatment Outcome

Fingerprint Dive into the research topics of 'The addition of arsenic trioxide to low-dose Ara-C in older patients with AML does not improve outcome'. Together they form a unique fingerprint.

Cite this