Arsenic Combined With All-Trans Retinoic Acid for Pediatric Acute Promyelocytic Leukemia: Report From the CCLG-APL2016 Protocol Study.
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Zheng Huyong, Jiang Hui, Hu Shaoyan, Liao Ning, Shen Diying, Tian Xin, Hao Guoping, Jin Runming, Li Jianxin, Fang Yongjun, Ju Xiuli, Liu Ansheng, Wang Ningling, Zhai Xiaowen, Zhu Jiashi, Hu Qun, Li Limin, Liu Wei, Sun Lirong, Wang Li, Dai Yunpeng, Feng Xiaoqin, Li Fu, Liang Hui, Luo Xinhui, Yan Mei, Yin Qingning, Chen Yan, Han Yueqin, Qu Lijun, Tao Yanling, Gao Hui, He Zhixu, Lin Limin, Luo Jixia, Pan Kaili, Zhang Jingrong, Zhang Rong, Zhou Min, Zhang Yuanyuan, Wang Linya, Zhang Ruidong, Xiao Peifang, Ling Yayun, Peng Xiaoxia, Peng Yaguang, Wang Tianyou, Chinese Children's Leukemia Group
Аннотация
METHODS: We conducted a multicenter trial at 38 hospitals in China. Patients with newly diagnosed APL were stratified into two risk groups according to baseline WBC count and FLT3-ITD mutation. ATRA plus arsenic trioxide or oral arsenic without chemotherapy were administered to the standard-risk group, whereas ATRA, arsenic trioxide, or oral arsenic plus reduced-dose anthracycline were administered to the high-risk group. Primary end points were event-free survival and overall survival at 2 years.
RESULTS: We enrolled 193 patients with APL. After a median follow-up of 28.9 months, the 2-year overall survival rate was 99% (95% CI, 97 to 100) in the standard-risk group and 95% (95% CI, 90 to 100) in the high-risk group (P = .088). The 2-year event-free survival was 97% (95% CI, 93 to 100) in the standard-risk group and 90% (95% CI, 83 to 96) in the high-risk group (P = .252). The plasma levels of arsenic were significantly elevated after treatment, with a stable effective level ranging from 42.9 to 63.2 ng/mL during treatment. In addition, plasma, urine, hair, and nail arsenic levels rapidly decreased to normal 6 months after the end of treatment.
CONCLUSION: Arsenic combined with ATRA is effective and safe in pediatric patients with APL, although long-term follow-up is still needed.