"ATRA plus Arsenic Trioxide for Acute Promyelocytic Leukemia".The New England Journal of Medicine. 2013. 369:111-121.
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading
Is ATRA plus arsenic trioxide as effective as the standard ATRA plus chemotherapy for the treatment of patients with low-to-intermediate-risk acute promyelocytic leukemia?
For patients with low-to-intermediate-risk acute promyelocytic leukemia, ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in terms of event-free survival and overall survival, with reduced hematologic toxicity but more hepatic toxicity.
Acute promyelocytic leukemia (APL) has become highly curable with the standard treatment of ATRA and chemotherapy, but pilot studies suggested that arsenic trioxide with or without ATRA may lead to reduced hematologic toxicity and high efficacy.
There are no specific guidelines recommending ATRA plus arsenic trioxide over standard chemotherapy regimens based on this study alone as the knowledge cutoff for this summary does not include any guidelines published after this study.
Prospective, randomized, multicenter, open-label, phase 3 noninferiority trial comparing ATRA-arsenic trioxide with standard ATRA-chemotherapy.
Patients aged 18 to 71 years with newly diagnosed, low-to-intermediate-risk APL (white-cell count, ≤10×10^9 per liter).
Inclusion Criteria
- Newly diagnosed APL classified as low-to-intermediate risk (white-cell count at diagnosis, ≤10×10^9 per liter) - Confirmed genetic diagnosis of PML-RARA fusion gene by RT-PCR, t(15;17) translocation, or microspeckled PML pattern by immunofluorescence - Aged 18 to 71 years
Exclusion Criteria
- High-risk APL - White-cell count greater than 10×10^9 per liter
Baseline Characteristics
- Comparable demographic, clinical, and biologic characteristics between the two treatment cohorts
Patients were randomized to receive ATRA plus arsenic trioxide for induction and consolidation therapy or standard ATRA-chemotherapy for induction, followed by consolidation and maintenance therapy with chemotherapy and ATRA.
Primary Outcome
- Event-free survival at 2 years with fewer failures (no remissions, relapses, or deaths) in the ATRA-arsenic trioxide group compared to the ATRA-chemotherapy group.
- Higher overall survival in the ATRA-arsenic trioxide group - Similar antileukemic efficacy - More hepatic toxicity but less hematologic toxicity and fewer infections in ATRA-arsenic trioxide group
- Funded by Associazione Italiana contro le Leucemie and others
- The study is published in The New England Journal of Medicine, DOI: 10.1056/NEJMoa1300874 - ClinicalTrials.gov number, NCT00482833