Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy Journal Article
| Authors: | Coutre, S. E.; Othus, M.; Powell, B.; Willman, C. L.; Stock, W.; Paietta, E.; Levitan, D.; Wetzler, M.; Attar, E. C.; Altman, J. K.; Gore, S. D.; Maher, T.; Kopecky, K. J.; Tallman, M. S.; Larson, R. A.; Appelbaum, F. R. |
| Article 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. © 2014 John Wiley & Sons Ltd. |
| Keywords: | adult; controlled study; aged; major clinical study; overall survival; fatigue; cancer recurrence; drug withdrawal; side effect; treatment duration; disease free survival; methotrexate; outcome assessment; polymerase chain reaction; infection; heart disease; nausea; neuropathy; randomized controlled trial; thrombocytopenia; vomiting; maintenance therapy; aminotransferase blood level; dyspnea; fever; pneumonia; arsenic trioxide; drug fatality; cancer regression; drug response; daunorubicin; promyelocytic leukemia; sepsis; headache; heart arrhythmia; aminotransferase; pericardial effusion; retinoic acid; treatment refusal; induction chemotherapy; pericarditis; gemtuzumab ozogamicin; mercaptopurine; respiratory failure; typhlitis; sinusitis; leukaemia trials; consolidation chemotherapy; disseminated intravascular clotting; human; male; female; priority journal; article; acute promyelocytic leukaemia; leukaemia clinical; malignant haematology |
| Journal Title: | British Journal of Haematology |
| Volume: | 165 |
| Issue: | 4 |
| ISSN: | 0007-1048 |
| Publisher: | John Wiley & Sons |
| Date Published: | 2014-05-01 |
| Start Page: | 497 |
| End Page: | 503 |
| Language: | English |
| DOI: | 10.1111/bjh.12775 |
| PROVIDER: | scopus |
| PUBMED: | 24528179 |
| PMCID: | PMC4064464 |
| DOI/URL: | |
| Notes: | Br. J. Haematol. -- Export Date: 2 June 2014 -- CODEN: BJHEA -- Source: Scopus |
