CAJ | 학술논문

目的比较去甲氧柔红霉素(IDA) 10 mg/m2和8 mg/m2(简称10和8 mg组)联合阿糖胞苷(IA)方案诱导治疗成人初发急性髓系白血病(AML)(除外急性早幼粒细胞白血病)患者的疗效、血液学不良反应及预后.方法回顾性分析2004年6月至2013年10月335例成人初发AML患者资料,其中IDA l0 mg组198例,8mg组137例,比较两组患者的第1疗程化疗反应、血液学不良反应及早期死亡率,分析IDA剂量对预后的影响.结果除外早期死亡的4例患者,331例可评估患者的第1疗程完全缓解(CR)率为72.5％,部分缓解(PR)率为10.0％,总反应(OR)率为82.5％.IDA 10 mg组第1疗程CR率及OR率均显著高于IDA 8 mg组(CR率:78.9％对63.5％,P=0.003; OR率:88.2％对75.4％,p=0.007).多因素分析显示,女性、初诊时HGB≥100 g/L、FLT3-ITD突变阴性、IDA剂量10 mg/m2是有利于第1疗程获得CR的因素.化疗后所有患者均出现4级血细胞减少,两组患者化疗后中性粒细胞绝对值≥0.5×109/L和PLT≥20×10VL恢复时间差异无统计学意义(P＞0.05).所有患者中位随访14(1～118)个月,98例(29.3％)复发,92例(27.5％)死亡,3年无病生存(DFS)率和总生存(OS)率分别为53.2％和58.9％.3年DFS和OS率在174例持续化疗患者中分别为34.2％和37.4％,在157例异基因造血干细胞移植患者中分别为74.5％和81.2％.多因素分析结果显示,诱导化疗时IDA剂量10 mg/m2是改善患者DFS (P=0.040)及OS (P=0.007)的独立因素.结论 IA“3+7”方案诱导治疗初发AML患者,IDA 10mg/m2与8 mg/m2相比,第1疗程CR率显著提高,血液学不良反应相似,并且改善DFS及OS.
목적 비교거갑양유홍매소(IDA) 10 mg/m2화8 mg/m2(간칭10화8 mg조)연합아당포감(IA)방안유도치료성인초발급성수계백혈병(AML)(제외급성조유립세포백혈병)환자적료효、혈액학불량반응급예후.방법 회고성분석2004년6월지2013년10월335례성인초발AML환자자료,기중IDA l0 mg조198례,8mg조137례,비교량조환자적제1료정화료반응、혈액학불량반응급조기사망솔,분석IDA제량대예후적영향.결과 제외조기사망적4례환자,331례가평고환자적제1료정완전완해(CR)솔위72.5％,부분완해(PR)솔위10.0％,총반응(OR)솔위82.5％.IDA 10 mg조제1료정CR솔급OR솔균현저고우IDA 8 mg조(CR솔:78.9％대63.5％,P=0.003; OR솔:88.2％대75.4％,p=0.007).다인소분석현시,녀성、초진시HGB≥100 g/L、FLT3-ITD돌변음성、IDA제량10 mg/m2시유리우제1료정획득CR적인소.화료후소유환자균출현4급혈세포감소,량조환자화료후중성립세포절대치≥0.5×109/L화PLT≥20×10VL회복시간차이무통계학의의(P＞0.05).소유환자중위수방14(1～118)개월,98례(29.3％)복발,92례(27.5％)사망,3년무병생존(DFS)솔화총생존(OS)솔분별위53.2％화58.9％.3년DFS화OS솔재174례지속화료환자중분별위34.2％화37.4％,재157례이기인조혈간세포이식환자중분별위74.5％화81.2％.다인소분석결과현시,유도화료시IDA제량10 mg/m2시개선환자DFS (P=0.040)급OS (P=0.007)적독립인소.결론 IA“3+7”방안유도치료초발AML환자,IDA 10mg/m2여8 mg/m2상비,제1료정CR솔현저제고,혈액학불량반응상사,병차개선DFS급OS.
Objective To compare the efficacy and toxicity of 10 mg/m2 or 8 mg/m2 idarubicin (Ida) combined with cytarabine (IA "3 +7" regimen) as induction chemotherapy for adult patients with newly diagnosed acute myeloid leukemia (AML).Methods From June 2004 to October 2013,335 adult AML (non acute promyelocytic leukemia) patients receiving the IA regimen as induction chemotherapy were enrolled,including 198 cases with 10 mg/m2 Ida and 137 cases with 8 mg/m2 Ida for 3 days.We compared the hematologic response,hematologic side effects and prognosis between the two regimens.Results Except for 4 early deaths,the complete remission (CR) rate after the first cycle of induction chemotherapy was 72.5％,10.0％ partial remission (PR) and 82.5％ overall remission (OR) rate.The CR and OR rates were higher in the 10 mg/m2 Ida group than the 8 mg/m2 Ida group (CR:78.9％ vs 63.5％,P=0.003; OR:88.2％ vs 75.4％,P=0.007).Multivariate analysis showed that female,HGB≥100 g/L,FLT3-ITD mutation negative and 10mg/m2 Ida were favorable factors for CR.All patients presented cytopenias of grade Ⅳ.There was no differences on the recovery time of ANC≥0.5 × 109/L and PLT≥20 × 109/L after induction chemotherapy.Within a median follow-up of 14 (1-118) months,98 (29.3％) patients relapsed,92 (27.5％) died.The disease-free survival (DFS) and overall survival (OS) at 3 years were 53.2％ and 58.9％,respectively.DFS and OS at 3-year were 34.2％ and 37.4％ in the chemotherapy cohort,74.5％ and 81.2％ in the transplant cohort.10 mg/m2 Ida was an independent favorite factor for DFS (P=0.040) and OS (P=0.007).Conclusion As compared to 8 mg/m2,10 mg/m2 Ida significantly improved the CR,with the same extent of hematological side effects,and was an independent favorite factor for DFS and OS.