Zhu Hong-Hu, Ma Ya-Fang, Yu Kang, Ouyang Gui-Fang, Luo Wen-Da, Pei Ren-Zhi, Xu Wei-Qun, Hu Hui-Xian, Mo Shu-Ping, Xu Xiao-Hua, Lan Jian-Ping, Shen Jian-Ping, Shou Li-Hong, Qian Shen-Xian, Feng Wei-Ying, Zhao Pu, Jiang Jin-Hong, Hu Bei-Li, Zhang Jin, Qian Su-Ying, Wu Gong-Qiang, Wu Wen-Ping, Qiu Lei, Li Lin-Jie, Lang Xiang-Hua, Chen Sai, Chen Li-Li, Guo Jun-Bin, Cao Li-Hong, Jiang Hui-Fang, Xia Yong-Ming, Le Jing, Zhao Jian-Zhi, Huang Jian, Zhang Yue-Feng, Lv Ya-Li, Hua Jing-Sheng, Hong Yong-Wei, Zheng Cui-Ping, Wang Ju-Xiang, Hu Bin-Fei, Chen Xiao-Hui, Zhang Li-Ming, Tao Shi, Xie Bing-Shou, Kuang Yue-Min, Luo Wen-Ji, Su Ping, Guo Jun, Wu Xiao, Jiang Wei, Zhang Hui-Qi, Zhang Yun, Chen Chun-Mei, Xu Xiao-Feng, Guo Yan, Tu Jin-Ming, Hu Shao, Yan Xiao-Yan, Yao Chen, Lou Yin-Jun, Jin Jie
Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Key Laboratory of Hematologic Malignancies, Diagnosis and Treatment, Hangzhou, China.
Front Oncol. 2021 Nov 16;11:762653. doi: 10.3389/fonc.2021.762653. eCollection 2021.
Most randomized trials for acute promyelocytic leukemia (APL) have investigated highly selected patients under idealized conditions, and the findings need to be validated in the real world. We conducted a population-based study of all APL patients in Zhejiang Province, China, with a total population of 82 million people, to assess the generalization of all-trans retinoic acid (ATRA) and arsenic as front-line treatment. The outcomes of APL patients were also analyzed. Between January 2015 and December 2019, 1,233 eligible patients were included in the final analysis. The rate of ATRA and arsenic as front-line treatment increased steadily from 66.2% in 2015 to 83.3% in 2019, with no difference among the size of the center (≥5 or <5 patients per year, = 0.12) or age (≥60 or <60 years, = 0.35). The early death (ED) rate, defined as death within 30 days after diagnosis, was 8.2%, and the 3-year overall survival (OS) was 87.9% in the whole patient population. Age (≥60 years) and white blood cell count (>10 × 10/L) were independent risk factors for ED and OS in the multivariate analysis. This population-based study showed that ATRA and arsenic as front-line treatment are widely used under real-world conditions and yield a low ED rate and a high survival rate, which mimic the results from clinical trials, thereby supporting the wider application of APL guidelines in the future.
大多数针对急性早幼粒细胞白血病（APL）的随机试验都在理想化条件下研究了经过高度筛选的患者，其研究结果需要在现实世界中得到验证。我们对中国浙江省所有APL患者进行了一项基于人群的研究，该省总人口为8200万，以评估全反式维甲酸（ATRA）和砷作为一线治疗的普遍性。我们还分析了APL患者的治疗结果。在2015年1月至2019年12月期间，共有1233例符合条件的患者纳入最终分析。ATRA和砷作为一线治疗的比例从2015年的66.2%稳步上升至2019年的83.3%，在不同规模的中心（每年≥5例或<5例患者，P = 0.12）或年龄组（≥60岁或<60岁，P = 0.35）之间无差异。在整个患者群体中，早期死亡（ED）率（定义为诊断后30天内死亡）为8.2%，3年总生存率（OS）为87.9%。在多因素分析中，年龄（≥60岁）和白细胞计数（>10×10⁹/L）是ED和OS的独立危险因素。这项基于人群的研究表明，在现实世界条件下，ATRA和砷作为一线治疗被广泛应用，且早期死亡率低、生存率高，这与临床试验结果相似，从而支持未来更广泛地应用APL治疗指南。
