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Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy
Author(s) -
Coutre Steven E.,
Othus Megan,
Powell Bayard,
Willman Cheryl L.,
Stock Wendy,
Paietta Elisabeth,
Levitan Denise,
Wetzler Meir,
Attar Eyal C.,
Altman Jessica K.,
Gore Steven D.,
Maher Tracy,
Kopecky Kenneth J.,
Tallman Martin S.,
Larson Richard A.,
Appelbaum Frederick R.
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12775
Subject(s) - arsenic trioxide , medicine , maintenance therapy , regimen , randomized controlled trial , methotrexate , acute promyelocytic leukemia , surgery , gastroenterology , chemotherapy , arsenic , retinoic acid , biochemistry , materials science , chemistry , metallurgy , gene
Summary 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 clinicaltrials.gov as # NCT 00492856.