The addition of gemtuzumab ozogamicin to low-dose Ara-C improves remission rate but does not significantly prolong survival in older patients with acute myeloid leukaemia: Results from the LRF AML14 and NCRI AML16 pick-a-winner comparison

Research output: Contribution to journalArticlepeer-review


  • A. K. Burnett
  • A. E. Hunter
  • D. Milligan
  • W. J. Kell
  • J. Yin
  • M. F. McMullin
  • H. Dignum
  • D. Bowen
  • N. H. Russell

External organisations

  • Cardiff University
  • University Medical Center Utrecht
  • Faculty of Medical and Human Sciences
  • Birmingham Heartlands Hospital, Birmingham, UK.
  • University Hospital of Wales, Cardiff, UK.
  • Manchester Royal Infirmary
  • Belfast City Hospital
  • Portsmouth Hospitals National Health Service Trust
  • Leeds Teaching Hospitals NHS Trust
  • Nottingham University Hospitals NHS Trust


The treatment of older patients with acute myeloid leukaemia, who are not considered suitable for conventional intensive therapy, is unsatisfactory. Low-dose Ara-C(LDAC) has been established as superior to best supportive care, but only benefits the few patients who enter complete remission. Alternative or additional treatments are required to improve the situation. This randomised trial compared the addition of the immunoconjugate, gemtuzumab ozogamicin (GO), at a dose of 5 mg on day 1 of each course of LDAC, with the intention of improving the remission rate and consequently survival. Between June 2004 and June 2010, 495 patients entered the randomisation. The addition of GO significantly improved the remission rate (30% vs 17%; odds ratio(OR) 0.48 (0.32-0.73); P=0.006), but not the 12 month overall survival (25% vs 27%). The reason for the induction benefit failing to improve OS was two-fold: survival of patients in the LDAC arm who did not enter remission and survival after relapse were both superior in the LDAC arm. Although the addition of GO to LDAC doubled the remission rate it did not improve overall survival. Maintaining remission in older patients remains elusive.


Original languageEnglish
Pages (from-to)75-81
Number of pages7
Issue number1
Publication statusPublished - 1 Jan 2013


  • AML, clinical trial, gemtuzumab ozogamicin

ASJC Scopus subject areas