维甲酸亚砷酸联合蒽环类药物治疗急性早幼粒细胞白血病的临床研究

Clinical study of all-trans retinoic acid,Arsenic Trioxide combined with anthracycline for newly diagnosed acute promyelocytic leukemia

目的回顾性研究全反式维甲酸(all-trans retinoic aid,ATRA)和亚砷酸(ATO)联合蒽环类抗生素(anthracy-cline,ATC)诱导和巩固治疗初发急性早幼粒细胞白血病(acute promyelocytic leukemia,APL)的疗效及不良反应。方法对17例初治APL患者予ATRA和ATO联合ATC方案诱导化疗,达完全缓解(CR)后,以ATC、ATRA、ATO交替序贯巩固治疗,用巢氏逆转录聚合酶链式反应(reverse transcription polymerase chain reaction,RT-PCR)的方法检测PML-RARα融合基因,三次阴性者进入ATRA维持治疗。结果 17例患者中CR 16例(94.7%),中位巩固治疗时间12月(8～13月)。16例CR患者的中位血液学持续性完全缓解(CCR)时间58.1月(95%CI:48.6～67.8),中位分子生物学CCR时间为53.8月(95%CI:42.8～64.7)。17例患者的三年总生存(OS)率(94.1±5.7)%,五年OS率(78.4±15.1)%。达到CR的16例患者中,三年无病生存(DFS)率(93.8±6.1)%,五年DFS率(71.4±14.6)%。结论 ATRA及ATO联合ATC治疗初发APL患者CR率高,CCR时间长,住院治疗时间短,不良反应较小。定期监测融合基因有助于早期发现复发,提高疗效。

Objective To retrospectively analyze the clinical efficacy and side effect of all-trans retinoic acid（ATRA）,ATO combined with anthracycline（ATC）as induction and consolidation regimens for newly diagnosed acute promyelocytic leukemia（APL）.Methods Seventeen newly diagnosed APL patients were treated with ATRA and ATO combined with ATC as induction therapy.After complete remission,three cycles of consolidation therapy were given,with alternation of ATC,ATRA and ATO.When PML-RARα fusion genes were consistently negative for three times during consolidation,the patients were treated with ATRA every three months as maintenance therapy.Results Sixteen of 17 patients（94.7%）in this study achieved complete remission（CR）.The median time of consolidation was 12 months（rang 8～13months）.Among the sixteen cases who achieved CR,the median time of three-year hematological continuous complete remission（CCR）duration was 58.1（95%CI：48.6～67.8）months and three-year molecular genetic CCR duration was 53.8（95%CI：42.8～64.7）months.Three-year and 5-year overall survival rates were（94.1±5.7）% and（78.4±15.1）% respectively.Among the sixteen CR cases,three-year disease free survival（DFS）and 5-year DFS were（93.8±6.1）% and（71.4±14.6）%,respectively.Conclusions The treatment of ATRA,ATO combined with ATC has some advantages in high CR rates,prolonged CCR duration,shorted hospitalized time and few side effects.The sequential detection of nested RT-PCR for PML-RARα transcript could predict relapse and improve prognosis.