Yuan Ye, Li Wei, Lin Dong, Mi Ying-chang, Wang Ying, Wei Hui, Liu Bing-cheng, Zhou Chun-lin, Liu Kai-qi, Wang Jin-Yu, Wei Shu-ning, Gong Ben-Fa, Zhao Xing-Li, Sun Ming-yuan, Wan Jian-xiang
Institute of Hematology and Blood Diseases Hospital, Tianjin, China.
Zhonghua Xue Ye Xue Za Zhi. 2011 Nov;32(11):752-7.
To assess complete remission (CR), the overall survival (OS), event-free survival (EFS) and adverse events of newly diagnosed acute promyelocytic leukemia (APL) with homoharringtonine (HHT) plus ATRA, to evaluate the therapeutic effect by comparing HHT plus ATRA with daunorubicin plus ATRA as induction regimen (HA with DA as post-remission regimen).
115 APL patients (54 in HHT group, 61 in DNR group) after long-term follow-up were enrolled in the analyses of clinical feature, chromosome karyotype, molecular biology, OS and EFS.
The overall CR of 115 patients was 100%, the median interval to achieve hematological CR was 32 (22 - 43) days, the overall median OS was within 0.23 - 77.34 months, median EFS was within 0.23 - 77.34 months. 3-year OS rate was 93%, 5-year OS rate 93%, 3-year EFS rate 85% and 5-year RFS rate 75% respectively. Converting to PML-RARα PCR-negative after the induction therapy in the HHT and DNR group was 31.3% and 15.5% respectively, at the end of 1 consolidation course was 68.6% and 77.6% respectively, while the remaining 4 patients tested PML-RARα PCR-negative at the end of 2 consolidation courses in the DNR group. While both groups obtained the identical molecular biology relapse rate (9.8% and 8.6%, respectively). Survival analysis indicated that no significant difference was found on OS and EFS between the HHT group and the DNR group (P = 0.206 and 0.506). 5-year OS rate was 87% for the HHT group while 98% for the DNR group, 5-years EFS rate was 80% for the HHT group while 71% for the DNR group. And the risk group was not the factor affecting OS and EFS (P = 0.615 and 0.416). Grade 2 fever in the HHT group was less than in the DNR group during induction therapy. And no difference was found in terms of liver dysfunction, renal dysfunction, cardiac dysfunction, and hematologic toxicity between two groups.
Our study demonstrated comparable therapeutic effect of HHT or DNR on APL. HHT was also well tolerated and didn't cause serious adverse events.
评估高三尖杉酯碱（HHT）联合全反式维甲酸（ATRA）治疗新诊断急性早幼粒细胞白血病（APL）的完全缓解（CR）、总生存期（OS）、无事件生存期（EFS）及不良事件，通过比较HHT联合ATRA与柔红霉素联合ATRA作为诱导方案（缓解后方案HA与DA）评估治疗效果。
纳入115例经长期随访的APL患者（HHT组54例，DNR组61例）进行临床特征、染色体核型、分子生物学、OS及EFS分析。
115例患者总CR率为100%，达到血液学CR的中位时间为32（22 - 43）天，总中位OS为0.23 - 77.34个月，中位EFS为0.23 - 77.3个月。三年OS率为93%，五年OS率为93%，三年EFS率为85%，五年RFS率为75%。诱导治疗后HHT组和DNR组PML-RARα PCR转阴率分别为31.3%和15.5%，1个巩固疗程结束时分别为68.6%和77.6%，而DNR组其余4例患者在2个巩固疗程结束时检测PML-RARα PCR转阴。两组分子生物学复发率相同（分别为9.8%和8.6%）。生存分析表明，HHT组与DNR组在OS和EFS方面无显著差异（P = 0.206和0.506）。HHT组五年OS率为87%，DNR组为98%；HHT组五年EFS率为80%，DNR组为71%。危险组不是影响OS和EFS的因素（P = 0.615和0.416）。诱导治疗期间HHT组2级发热少于DNR组。两组在肝功能、肾功能、心功能及血液学毒性方面无差异。
我们的研究表明HHT与DNR对APL的治疗效果相当。HHT耐受性良好，未引起严重不良事件。
