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采用伊达比星、阿糖胞苷、依托泊苷及粒细胞集落刺激因子预激进行强化化疗治疗晚期骨髓增生异常综合征和高危急性髓系白血病患者。

Intensive chemotherapy with idarubicin, cytarabine, etoposide, and G-CSF priming in patients with advanced myelodysplastic syndrome and high-risk acute myeloid leukemia.

作者信息

Hofmann W K, Heil G, Zander C, Wiebe S, Ottmann O G, Bergmann L, Hoeffken K, Fischer J T, Knuth A, Kolbe K, Schmoll H J, Langer W, Westerhausen M, Koelbel C B, Hoelzer D, Ganser A

机构信息

Department of Hematology/Oncology, Johann Wolfgang Goethe University Hospital, University of Frankfurt/Main, Theodor-Stern-Kai 7, Frankfurt/Main, Germany.

出版信息

Ann Hematol. 2004 Aug;83(8):498-503. doi: 10.1007/s00277-004-0889-0. Epub 2004 May 20.

Abstract

In an attempt to improve the complete remission (CR) rates and to prolong the remission duration especially in elderly patients > 50 years of age, we have used a combination chemotherapy of idarubicin (10 mg/m2 IV x 3 days), cytarabine (AraC, 100 mg/m2 CIVI x 7d), and etoposide (100 mg/m2 x 5 days) in combination with granulocyte colony-stimulating factor (G-CSF) priming [5 mg/kg SQ day 1 until absolute neutrophil count (ANC) recovery] for remission induction. Responding patients received two consolidation courses of idarubicin, AraC, and etoposide, followed by a late consolidation course of intermediate-dose AraC (600 mg/m2 IV every 12 h x 5 days) and amsacrine (60 mg/m2 IV x 5 days). A total of 112 patients (57 male/55 female) with a median age of 58 years (range: 22-75) have been entered and are evaluable for response: 19 refractory anemia with excess of blast cells in transformation (RAEB-T), 84 acute myeloid leukemia (AML) evolving from myelodysplastic syndrome (MDS), and 9 secondary AML after chemotherapy/radiotherapy. The overall CR rate was 62%, partial remission (PR) rate 10%, treatment failure 16%, and early death rate 12%. The CR rate was higher in patients < or = 60 years (68 vs 55%), mainly due to a lower early death rate (5 vs 21%, p<0.001). After a median follow-up of 58 months, the median overall survival is 14.5% and median duration of relapse-free survival 8 months. After 60 months, the probability of CR patients to still be in CR and alive is 16% (20% in patients < or = 60 years and 13% in patients >60 years), while the probability of overall survival is 12% (15% in patients < or = 60 years and 9% in patients > 60 years). Compared to our previous trial (AML-MDS Study 01-92) which was done with identical chemotherapy but no G-CSF priming in 110 patients with RAEB-T, AML after MDS, or secondary AML (identical median age, age range, and distribution of subtypes), the CR rate in all patients, as well as CR rate, overall survival, and relapse-free survival in patients > 60 years have significantly been improved. Thus, intensive chemotherapy with G-CSF priming is both well tolerated and highly effective for remission induction in these high-risk patients.

摘要

为提高完全缓解(CR)率并延长缓解期,尤其是年龄>50岁的老年患者,我们采用了伊达比星(10mg/m²静脉注射,共3天)、阿糖胞苷(AraC,100mg/m²持续静脉输注,共7天)和依托泊苷(100mg/m²,共5天)联合粒细胞集落刺激因子(G-CSF)预激(第1天皮下注射5mg/kg,直至绝对中性粒细胞计数[ANC]恢复)进行缓解诱导化疗。缓解患者接受两个疗程的伊达比星、阿糖胞苷和依托泊苷巩固治疗,随后接受一个疗程的中剂量阿糖胞苷(600mg/m²静脉注射,每12小时1次,共5天)和安吖啶(60mg/m²静脉注射,共5天)的晚期巩固治疗。共有112例患者(57例男性/55例女性)入组,中位年龄58岁(范围:22 - 75岁),可进行疗效评估:19例转化中的原始细胞过多难治性贫血(RAEB-T),84例由骨髓增生异常综合征(MDS)演变而来的急性髓系白血病(AML),以及9例化疗/放疗后继发性AML。总CR率为62%,部分缓解(PR)率为10%,治疗失败率为16%,早期死亡率为12%。年龄≤60岁患者的CR率更高(68%对55%),主要是因为早期死亡率较低(5%对21%,p<0.001)。中位随访58个月后,中位总生存率为14.5%,无复发生存期的中位持续时间为8个月。60个月后,CR患者仍处于CR且存活的概率为16%(年龄≤60岁患者为20%,年龄>60岁患者为13%),而总生存概率为12%(年龄≤60岁患者为15%,年龄>60岁患者为9%)。与我们之前的试验(AML-MDS研究01-92)相比,该试验对110例RAEB-T、MDS后AML或继发性AML患者(中位年龄、年龄范围和亚型分布相同)采用了相同的化疗方案,但未进行G-CSF预激,所有患者的CR率以及年龄>60岁患者的CR率、总生存率和无复发生存率均有显著提高。因此,对于这些高危患者,采用G-CSF预激的强化化疗耐受性良好且诱导缓解效果显著。

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