Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy Academic Article uri icon


MeSH Major

  • Antineoplastic Combined Chemotherapy Protocols
  • Consolidation Chemotherapy
  • Leukemia, Promyelocytic, Acute


  • Aa total of 105 patients (age ≥18 years) with newly diagnosed low or intermediate risk acute promyelocytic leukaemia (APL) were treated with a standard induction and consolidation regimen including arsenic trioxide (ATO). Sixty-eight patients who were polymerase chain reaction (PCR) negative for PML-RARA post-consolidation were randomized to either 1 year of maintenance with tretinoin, mercaptopurine and methotrexate, or observation. Enrollment in this non-inferiority trial was stopped prematurely due to slow accrual. With a median follow up of 36·1 months, the overall survival of the 105 patients was 93%, and there have been no relapses in the patients randomized to maintenance or observation. These results demonstrate that cures can be expected in >90% of patients with low and intermediate risk APL and suggest that maintenance therapy may not be needed if patients are treated with an intensive post-remission regimen including ATO. This trial was registered at as #NCT00492856.

publication date

  • January 2014



  • Academic Article



  • eng

PubMed Central ID

  • PMC4064464

Digital Object Identifier (DOI)

  • 10.1111/bjh.12775

PubMed ID

  • 24528179

Additional Document Info

start page

  • 497

end page

  • 503


  • 165


  • 4