Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.
Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.
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DOI：
10.1038/s41375-018-0268-9
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发表时间：
2018-12
期刊：
影响因子：
11.4
通讯作者：
AML-CG
中科院分区：
文献类型：
--
作者：
Braess J;Amler S;Kreuzer KA;Spiekermann K;Lindemann HW;Lengfelder E;Graeven U;Staib P;Ludwig WD;Biersack H;Ko YD;Uppenkamp MJ;De Wit M;Korsten S;Peceny R;Gaska T;Schiel X;Behringer DM;Kiehl MG;Zinngrebe B;Meckenstock G;Roemer E;Medgenberg D;Spaeth-Schwalbe E;Massenkeil G;Hindahl H;Schwerdtfeger R;Trenn G;Sauerland C;Koch R;Lablans M;Faldum A;Görlich D;Bohlander SK;Schneider S;Dufour A;Buske C;Fiegl M;Subklewe M;Braess B;Unterhalt M;Baumgartner A;Wörmann B;Beelen D;Hiddemann W;AML-CG
在新诊断的急性髓性白血病成年患者中，将S-HAM方案的剂量密集诱导与标准双诱导治疗进行比较。患者被集中随机（1:1）分为S-HAM（第8天开始的第二个化疗周期=“剂量密集”）和TAD-HAM或HAM（-HAM）双诱导（第21天开始的第二个周期=“标准”）。387例可评估患者随机分为S-HAM组（N = 203）和标准双诱导组（N = 184）。S-HAM（77%）和双诱导（72%）的主要终点总缓解率（ORR）由完全缓解（CR）和不完全缓解（CRi）组成，差异无统计学意义（P = 0.202）。S-HAM组的中位总生存期为35个月，双诱导组为25个月（P = 0.323）。S-HAM术后临界白细胞减少持续时间（中位29天）显著低于双诱导（中位44天）-P < 0.001。与标准诱导（中位49天）相比，S-HAM术后住院时间（中位37天）显著缩短-P < 0.001。综上所述，S-HAM方案的剂量密集诱导治疗具有良好的趋势，但与标准双诱导相比，ORR和OS无显著差异。S-HAM显著缩短临界白细胞减少和住院时间2周。
Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 = “dose-dense”) and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21 = “standard”). 387 evaluable patients were randomly assigned to S-HAM (N = 203) and to standard double induction (N = 184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P = 0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P = 0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)—P < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)—P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks.
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影响因子：
45.3
作者：
Schaich, Markus;Parmentier, Stefani;Ehninger, Gerhard
通讯作者：
Ehninger, Gerhard
影响因子：
20.3
作者：
Metzeler, Klaus H.;Herold, Tobias;Spiekermann, Karsten
通讯作者：
Spiekermann, Karsten
影响因子：
12.8
作者：
Jaramillo, S.;Benner, A.;Schlenk, R. F.
通讯作者：
Schlenk, R. F.
影响因子：
45.3
作者：
Büchner, T;Berdel, WE;Hiddemann, W
通讯作者：
Hiddemann, W
影响因子：
51.1
作者：
Rollig, Christoph;Serve, Hubert;Ehninger, Gerhard
通讯作者：
Ehninger, Gerhard