Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)
Li Chen, Hongming Zhu, Yan Li, Qi-Fa Liu, Yu Hu, Jian-Feng Zhou, Jie Jin, Jian-Da Hu, Ting Liu, Depei Wu, Jie-Ping Chen, Yong-Rong Lai, Jianxiang Wang, Juan Li, Jian-Yong Li, Xin Du, Xin Wang, Ming-Zhen Yang, Jinsong Yan, Gui-Fang Ouyang, Li Liu, Ming Hou, Xiao‐Jun Huang, Xiao-Jing Yan, Dan Xu, Wei‐Ming Li, Deng-Ju Li, Yinjun Lou, Zheng-Jun Wu, Ting Niu, Ying Wang, Xiaoyang Li, Jian-Hua You, Hui-Jin Zhao, Yù Chen, Yang Shen, Qiu-Sheng Chen, Yù Chen, Jian Li, Bingshun Wang, Weili Zhao, Jian‐Qing Mi, Kankan Wang, Jiong Hu, Zhu Chen, Sai‐Juan Chen, Jun-Min Li
Abstract
Significance The APL2012 trial is currently the largest randomized, multicenter clinical study of APL based on ATRA-ATO treatment with risk stratification. We enrolled 855 newly diagnosed APL patients during December 2012 to December 2017 for careful follow-up. All patients received ATRA-ATO–based protocols for remission induction. At the consolidation phase, the key part of the trial, ATO was used to replace or reduce chemotherapy in a risk-stratified way. Patients were then treated with ATRA-ATO as maintenance. The results indicated not only the noninferiority of ATO compared to intensive chemotherapy in survival but also an advantage in adverse effects. The trial provides support for the ATO regimen as a standard for making further refinements in the treatment of this highly curable disease.