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A phase 2 study of ATRA, arsenic trioxide, and gemtuzumab ozogamicin in patients with high-risk APL (SWOG 0535)
| Content Provider | Scilit |
|---|---|
| Author | Lancet, Jeffrey E. Moseley, Anna B. Coutre, Steven E. DeAngelo, Daniel Othus, Megan Tallman, Martin S. Litzow, Mark R. Komrokji, Rami S. Erba, Harry P. Appelbaum, Frederick R. |
| Copyright Year | 2020 |
| Description | High-risk acute promyelocytic leukemia (APL) remains a therapeutic challenge, with higher associated rates of early mortality and relapse than standard-risk APL. All-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) is a well-established treatment for patients with standard-risk APL, but it is not well defined for those with high-risk APL. In a prior study of patients with high-risk APL, the addition of gemtuzumab ozogamicin (GO) to ATO plus ATRA suggested benefit. The SWOG Cancer Research Network conducted a phase 2 study to confirm the efficacy and safety of the combination of ATRA plus ATO plus GO in treating high-risk APL patients. The primary end points were 3-year event-free survival (EFS) and early (6-week) death rates associated with this combination. Seventy patients were treated. With a median follow-up of 3.4 years, the 3-year EFS and overall survival estimates were 78% (95% confidence interval [CI], 67%-86%) and 86% (95% CI, 75%-92%), respectively. Overall, 86% of patients achieved complete response. The 6-week mortality rate was 11%. The most common treatment-emergent toxicities during the induction phase included febrile neutropenia, aspartate aminotransferase/alanine aminotransferase elevation, hyperglycemia, hypoxia, headache, and prolonged QT interval corrected for heart rate. Retinoic acid syndrome occurred in 9% of patients. Approximately 37% of patients did not complete all planned courses of postremission therapy. The combination of ATRA plus ATO plus GO in high-risk APL patients was effective and generally well tolerated, suggesting an opportunity to offer a chemotherapy-free induction platform for patients with this disease. This trial was registered at www.clinicaltrials.gov as #NCT00551460. |
| Related Links | https://ashpublications.org/bloodadvances/article-pdf/4/8/1683/1724999/advancesadv2019001278.pdf |
| Ending Page | 1689 |
| Page Count | 7 |
| Starting Page | 1683 |
| DOI | 10.1182/bloodadvances.2019001278 |
| Journal | Blood advances |
| Issue Number | 8 |
| Volume Number | 4 |
| Language | English |
| Publisher | American Society of Hematology |
| Publisher Date | 2020-04-28 |
| Access Restriction | Open |
| Subject Keyword | Hematology High Risk Retinoic Acid Gemtuzumab Ozogamicin Apl Patients Risk Apl Associated Rates Ato Plus Journal: Blood advances (Vol- 101, Issue- 8) |
| Content Type | Text |
| Resource Type | Article |
