摘要
目的比较高三尖杉酯碱（HHT）±柔红霉素（DNR）联合全反式维甲酸（ATRA）和以DNR为基础的方案治疗初诊中低危急性早幼粒细胞白血病（APL）患者的疗效及耐受性。方法采用前瞻性随机对照研究方法，将96例初诊中低危APL患者随机分配至HHT组、DNR组和HHT＋DNR组，比较三组患者的完全缓解（CR）率、总生存（OS）及无事件生存（EFS）情况。结果HHT组31例，DNR组33例，HHT＋DNR组32例，三组患者一般资料具有可比性。三组治疗方案诱导治疗CR率均为100%，无早期死亡患者。三组诱导治疗期间WBC达峰值的中位时间分别为9（1-27）、7（1-27）和4（1-23 ）d ，HHT＋DNR组短于HHT组（P=0.008）和DNR组（P=0.240）。三组治疗方案在维甲酸综合征的发生率，达CR的中位时间，WBC峰值及血小板、红细胞、血浆输注量方面的差异均无统计学意义（P值均〉0.05）。所有患者均在巩固治疗阶段达分子生物学完全缓解（CMR），三组患者达CMR的时间差异无统计学意义（P〉0.05）。HHT组、DNR组及HHT＋DNR组的3年OS率分别为95.0%、100.0%、 91.0%；3年EFS率分别为93.0%、90.0%、85.0%，差异均无统计学意义（P值分别为0.595和0.382）。三组患者不良事件发生率比较差异无统计学意义（P〉0.05）。结论以HHT联合ATRA为基础的诱导、巩固治疗方案可以有效治疗初诊APL，疗效与以蒽环类药物为基础的方案类似，可以作为APL的治疗选择之一。临床试验注册 中国临床试验注册中心，ChiCTR-TRC-12002628。
ObjectiveTo compare the efficacy and toxicities of combining homoharringtonine （HHT）±daunorubicin （DNR） with all-trans-retinoic acid （ATRA） based therapy and DNR plus ATRA based therapy in newly diagnosed low/intermediate risk acute promyelocytic leukemia （APL）.MethodsA total of 96 newly diagnosed patients with APL were randomized to HHT group, DNR group and HHT＋ DNR group prospectively. The complete remission （CR） rate, the overall survival （OS） and event-free survival （EFS） of three groups were analyzed.ResultsThere were 31 patients in HHT group, 33 patients in DNR group and 32 patients in HHT＋ DNR group. The baseline characteristics of three groups were similar. No patient died during induction therapy. The morphologic CR rate was 100.0%. The median time to peak WBC counts in HHT＋DNR group （4 days, range： 1-23 days） was significantly shorter than that in HHT group （9 days, range： 1-27 days） （P=0.008） and DNR group （7 days, range： 1-27 days） （P=0.240）. There was no difference among three groups about the incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions （P 〉0.05）. All patients achieved complete molecular remission （CMR） during consolidation therapy. The interval to achieve CMR was no significantly difference among three groups （P 〉0.05）. The 3-year OS rates for HHT group, DNR group and HHT＋DNR group were 95.0%, 100.0% and 91.0%, respectively （P=0.595）. The 3-year EFS rates for three groups were 93.0%, 90.0% and 85.0% （P=0.382）. No difference was found in the incidence of adverse events among three groups （P 〉0.05）.
ConclusionsSimilar to DNR plus ATRA based therapy, HHT plus ATRA based induction and consolidation therapy should be one of highly-efficient treatment options for newly diagnosed APL. Clinical trial registration Chinese Clinical Trial Registry, ChiCTR-TRC-12002628.
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2016年第3期183-188,共6页
Chinese Journal of Hematology
基金
国家自然科学基金青年基金（81400136）
“十二五”国家科技支撑计划（2014BAI09B12）
天津市应用基础与前沿技术研究计划（15JCYBJC25000、15JCYBJC25700）
