Homoharringtonine-Based Induction Regimen Improved the Remission Rate and Survival Rate in Chinese Childhood AML: A Report From the CCLG-AML 2015 Protocol Study

PURPOSE: Homoharringtonine (HHT) is commonly used for the treatment of Chinese adult AML, and all-trans retinoic acid (ATRA) has been verified in acute promyelocytic leukemia (APL). However, the efficacy and safety of HHT-based induction therapy have not been confirmed for childhood AML, and ATRA-ba...

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Detalles Bibliográficos
Autores principales: Li, Jing, Gao, Ju, Liu, Ansheng, Liu, Wei, Xiong, Hao, Liang, Changda, Fang, Yongjun, Dai, Yunpeng, Shao, Jingbo, Yu, Hui, Wang, Lingzhen, Wang, Li, Yang, Liangchun, Yan, Mei, Zhai, Xiaowen, Shi, Xiaodong, Tian, Xin, Ju, Xiuli, Chen, Yan, Wang, Jing, Zhang, Leping, Liang, Hui, Chen, Sen, Zhang, Jingrong, Cao, Haixia, Jin, Jiao, Hu, Qun, Wang, Junlan, Wang, Yilin, Zhou, Min, Han, Yueqin, Zhang, Rong, Zhao, Weihong, Wang, Xiaoli, Lin, Limin, Zhang, Ruidong, Gao, Chao, Xu, Liting, Zhang, Yuanyuan, Fan, Jia, Wu, Ying, Lin, Wei, Yu, Jiaole, Qi, Peijing, Huang, Pengli, Peng, Xiaoxia, Peng, Yaguang, Wang, Tianyou, Zheng, Huyong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2023
Materias:
ORIGINAL REPORTS
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10617822/
https://www.ncbi.nlm.nih.gov/pubmed/37531592
http://dx.doi.org/10.1200/JCO.22.02836
Descripción
Sumario:PURPOSE: Homoharringtonine (HHT) is commonly used for the treatment of Chinese adult AML, and all-trans retinoic acid (ATRA) has been verified in acute promyelocytic leukemia (APL). However, the efficacy and safety of HHT-based induction therapy have not been confirmed for childhood AML, and ATRA-based treatment has not been evaluated among patients with non-APL AML. PATIENTS AND METHODS: This open-label, multicenter, randomized Chinese Children's Leukemia Group-AML 2015 study was performed across 35 centers in China. Patients with newly diagnosed childhood AML were first randomly assigned to receive an HHT-based (H arm) or etoposide-based (E arm) induction regimen and then randomly allocated to receive cytarabine-based (AC arm) or ATRA-based (AT arm) maintenance therapy. The primary end points were the complete remission (CR) rate after induction therapy, and the secondary end points were the overall survival (OS) and event-free survival (EFS) at 3 years. RESULTS: We enrolled 1,258 patients, of whom 1,253 were included in the intent-to-treat analysis. The overall CR rate was significantly higher in the H arm than in the E arm (79.9% v 73.9%, P = .014). According to the intention-to-treat analysis, the 3-year OS was 69.2% (95% CI, 65.1 to 72.9) in the H arm and 62.8% (95% CI, 58.7 to 66.6) in the E arm (P = .025); the 3-year EFS was 61.1% (95% CI, 56.8 to 65.0) in the H arm and 53.4% (95% CI, 49.2 to 57.3) in the E arm (P = .022). Among the per-protocol population, who received maintenance therapy, the 3-year EFS did not differ significantly across the four arms (H + AT arm: 70.7%, 95% CI, 61.1 to 78.3; H + AC arm: 74.8%, 95% CI, 67.0 to 81.0, P = .933; E + AC arm: 72.9%, 95% CI, 65.1 to 79.2, P = .789; E + AT arm: 66.2%, 95% CI, 56.8 to 74.0, P = .336). CONCLUSION: HHT is an alternative combination regimen for childhood AML. The effects of ATRA-based maintenance are comparable with those of cytarabine-based maintenance therapy.

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