Inclusion of chemotherapy in addition to anthracycline in the treatment of acute promyelocytic leukaemia does not improve outcomes: results of the MRC AML15 trial

A K Burnett, R K Hills, D Grimwade, J V Jovanovic, J Craig, M F McMullin, J Kell, K Wheatley, J A L Yin, A Hunter, D Milligan, N H Russell, United Kingdom National Cancer Research Institute Acute Myeloid Leukaemia Subgroup

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Two hundred eighty-five patients, median age 42, with PML-RARa-positive acute promyelocytic leukaemia were randomised to Ara-C-containing 'Medical Research Council (MRC) Chemotherapy'+ATRA (All-trans-retinoic acid) or anthracycline+ATRA (modified 'Spanish') therapy. MRC treatment comprised four courses with ATRA in courses 1-2. Spanish treatment comprised four anthracycline-based courses with ATRA in courses 1-3. In course 3 patients were randomised to gemtuzumab ozogamicin (GO) or not. The Spanish arm received 24-month maintenance. Patients were sequentially molecularly monitored. Quality of life was assessed at baseline, 3, 6, 9, 12, 24 months. Remission rates were similar in both arms (93%): cumulative incidence of haematological relapse (CIHR) was 6% at 5 years; 5 patients relapsed molecularly. Survival post relapse was 80%. There were more deaths in remission in the MRC arm (4% vs 10%: P=0.2). The overall 5-year relapse-free and overall survival was similar between arms (81% vs 82% and 84% vs 83%, respectively). More supportive care and hospitalisation (81.8 vs 63 days, P10 × 10(9)/l) was not prognostic overall, or within treatment arms. Both approaches deliver similar results with minor differences in quality of life. MRC treatment required more hospitalisation. This suggests that additional chemotherapy, Ara-C in particular, is not required.
Original languageEnglish
Pages (from-to)843-851
JournalLeukemia
Volume27
Issue number4
Early online date22 Jan 2013
DOIs
Publication statusPublished - Apr 2013

Keywords

  • Adolescent
  • Adult
  • Aged
  • Anthracyclines
  • Antineoplastic Combined Chemotherapy Protocols
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Leukemia, Promyelocytic, Acute
  • Male
  • Middle Aged
  • Quality of Life
  • Treatment Outcome
  • Young Adult

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