title: Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy.
abstract: 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 #NCT00492856.
authors: Stanford University School of Medicine, Stanford, CA, USA.
authors: Steven E
authors: SE
authors: Coutre
authors: Megan
authors: M
authors: Othus
authors: Bayard
authors: B
authors: Powell
authors: Cheryl L
authors: CL
authors: Willman
authors: Wendy
authors: W
authors: Stock
authors: Elisabeth
authors: E
authors: Paietta
authors: Denise
authors: D
authors: Levitan
authors: Meir
authors: M
authors: Wetzler
authors: Eyal C
authors: EC
authors: Attar
authors: Jessica K
authors: JK
authors: Altman
authors: Steven D
authors: SD
authors: Gore
authors: Tracy
authors: T
authors: Maher
authors: Kenneth J
authors: KJ
authors: Kopecky
authors: Martin S
authors: MS
authors: Tallman
authors: Richard A
authors: RA
authors: Larson
authors: Frederick R
authors: FR
authors: Appelbaum
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects; D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000008:administration & dosage / Q000009:adverse effects; D014408:Biomarkers, Tumor; D060830:Consolidation Chemotherapy; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004285:Dogs; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy*; D060046:Maintenance Chemotherapy; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage / Q000009:adverse effects; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000097:blood; D010087:Oxides / Q000008:administration & dosage / Q000009:adverse effects; D010976:Platelet Count; D012074:Remission Induction; D012306:Risk; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D001152:Arsenicals; D014408:Biomarkers, Tumor; D015514:Oncogene Proteins, Fusion; D010087:Oxides; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein; D003561:Cytarabine; D014212:Tretinoin; D000079982:Gemtuzumab; D015122:Mercaptopurine; D000077237:Arsenic Trioxide; D008727:Methotrexate; D003630:Daunorubicin
keywords: acute promyelocytic leukaemia; leukaemia clinical; leukaemia trials; malignant haematology