Arsenic trioxide versus Realgar-Indigo naturalis formula in non-high-risk acute promyelocytic leukemia: a multicenter, randomized trial
Realgar-Indigo naturalis formula (RIF) is an oral form of arsenic that is effective against acute promyelocytic leukemia (APL). This multicenter, randomized, controlled trial compared the efficacy of all-trans retinoic acid (ATRA) plus RIF with ATRA plus arsenic trioxide (ATO) in a simplified regimen for non-high-risk APL. Following induction therapy with ATRA and ATO, participants were randomly assigned to receive either ATRA plus ATO or ATRA plus RIF both in a 2-week on 2-week off schedule for consolidation therapy. Once achieving molecular complete remission, the regimen was administered for a total of six cycles. All of 108 eligible patients achieved hematological complete remission after induction therapy. The median follow-up time was 29 months. The primary endpoint of 2-year disease-free survival was 97% in the ATRA-RIF arm and 98% in the ATRA-ATO arm, respectively (the ATRA-RIF arm was found to be non-inferior to the ATRA-ATO arm, [P<0.01], with a percentage difference of -1% [95% confidence interval: -4.8 to 6.9]). No deaths have been observed. Most adverse events were moderate. This study confirms the non-inferiority of RIF to ATO for non-high-risk APL, while also offering a more favorable regimen schedule for post-remission therapy (clinicaltrials gov. identifier: NCT02899169).
Authors
- David N. Wald
- Yin-Suo Zheng
- Han‐Fei Ding (ORCID: https://orcid.org/0000-0001-5702-3439)
- Pengcheng He (ORCID: https://orcid.org/0000-0001-9531-531X)
- Xinhua Lu (ORCID: https://orcid.org/0000-0001-8132-8697)
- Haitao Zhang (ORCID: https://orcid.org/0000-0002-6212-7707)
- Olubukola M. Abiona (ORCID: https://orcid.org/0000-0002-2745-1691)
- Li Liu (ORCID: https://orcid.org/0000-0002-6268-1855)
- Di Wu (ORCID: https://orcid.org/0000-0001-8490-3722)
- Jing Li (ORCID: https://orcid.org/0000-0003-4038-3088)
- Shu Chen (ORCID: https://orcid.org/0000-0003-2718-7701)
- Xiaohui Wang (ORCID: https://orcid.org/0000-0002-5053-1008)
- Rong Zhang (ORCID: https://orcid.org/0000-0003-2941-4808)
- Xiaojuan Zhang (ORCID: https://orcid.org/0000-0002-4441-0197)
- Huiyun Zhang (ORCID: https://orcid.org/0000-0002-2686-2472)
- Huaiyu Wang (ORCID: https://orcid.org/0000-0002-6428-081X)
- Sha Gong (ORCID: https://orcid.org/0000-0001-7044-4668)
- Weiwei Qin (ORCID: https://orcid.org/0000-0001-7987-1658)
- Xiaohong Lü (ORCID: https://orcid.org/0000-0001-6463-959X)
- Suhua Wei
- Ranjbarha Seifollah
Institutions
- First Affiliated Hospital of Xi'an Jiaotong University (CN)
- Baoji City Central Hospital (CN)
- Qinghai Provincial Peoples Hospital (CN)
- Case Western Reserve University (US)
- Air Force Medical University (CN)
Publication Details
- Journal
- Haematologica
- Published
- 2024-11-07
- DOI
- https://doi.org/10.3324/haematol.2024.285905
- Citations
- 1
- Primary Topic
- Retinoids in leukemia and cellular processes
- Type
- article
- Field-Weighted Citation Impact
- 0.23
Funders
- Xi’an Jiaotong University