An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial)

Autor: Huai-Yu Wang, Sha Gong, Guo-Hui Li, Ya-Zhou Yao, Yin-Suo Zheng, Xiao-Hong Lu, Su-Hua Wei, Wei-Wei Qin, Hai-Bo Liu, Meng-Chang Wang, Jie-Ying Xi, Li-Mei Chen, Mei Zhang, Xin-Xin Zhang, Hui-Yun Zhang, Cheng-Sheng Zhang, David N. Wald, Hong-Hu Zhu, Li Liu, Peng-Cheng He
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Blood Cancer Journal, Vol 12, Iss 11, Pp 1-8 (2022)
Druh dokumentu: article
ISSN: 2044-5385
DOI: 10.1038/s41408-022-00753-y
Popis: Abstract The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has been demonstrated to have comparable effectiveness or better to ATRA and chemotherapy (CHT) in non-high-risk acute promyelocytic leukemia (APL). However, the efficacy of ATRA-ATO compared to ATRA-ATO plus CHT in high-risk APL remains unknown. Here we performed a randomized multi-center non-inferiority phase III study to compare the efficacy of ATRA-ATO and ATRA-ATO plus CHT in newly diagnosed all-risk APL to address this question. Patients were assigned to receive ATRA-ATO for induction, consolidation, and maintenance or ATRA-ATO plus CHT for induction followed by three cycles of consolidation therapy, and maintenance therapy with ATRA-ATO. In the non-CHT group, hydroxyurea was used to control leukocytosis. A total of 128 patients were treated. The complete remission rate was 97% in both groups. The 2-year disease-free, event-free survival rates in the non-CHT group and CHT group in all-risk patients were 98% vs 97%, and 95% vs 92%, respectively (P = 0.62 and P = 0.39, respectively). And they were 94% vs 87%, and 85% vs 78% in the high-risk patients (P = 0.52 and P = 0.44, respectively). This study demonstrated that ATRA-ATO had the same efficacy as the ATRA-ATO plus CHT in the treatment of patients with all-risk APL.
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