Lancet Oncol:R-MegaCHOEP方案无益于年轻高危侵袭性B细胞淋巴瘤患者((DSHNHL 2002-1研究)

2012-11-26 MedSci Lancet Oncol

    在年轻的高危侵袭性B细胞淋巴瘤患者中,在自体造血干细胞移植术后进行大剂量治疗时一线治疗的一部分。本文的研究者旨在比较自体造血干细胞移植术后,细胞毒制剂化疗与常规化疗对患者生存情况的影响。Norbert Schmitz等进行的相关研究的结果发表在Lancet Oncol 11月最新的在线期刊上。    这个研究是开放标签式的临床随机

    在年轻的高危侵袭性B细胞淋巴瘤患者中,在自体造血干细胞移植术后进行大剂量治疗时一线治疗的一部分。本文的研究者旨在比较自体造血干细胞移植术后,细胞毒制剂化疗与常规化疗对患者生存情况的影响。Norbert Schmitz等进行的相关研究的结果发表在Lancet Oncol 11月最新的在线期刊上。
    这个研究是开放标签式的临床随机对照研究,研究比较了常规化疗方案(环磷腺癌, 阿霉素, 长春新碱,依托泊苷,强的松)联合利妥昔单抗(R-CHOEP-14)与剂量逐渐升高的大剂量化疗方案联合利妥昔单抗(R-MegaCHOEP)这两种方案对进行了自体造血干细胞移植术的高危侵袭性B细胞淋巴瘤患者的疗效差别,这些患者的年龄介于18岁至60岁之间。采用Pocock 最小算法按照1:1的比例将患者随机分组。研究的主要终点为患者的生存情况。采用意向治疗分析对研究结果进行分析。本研究已在ClinicalTrials.gov注册。
    共有136名患者被纳入R-CHOEP-14组,另有139名患者被纳入R-MegaCHOEP组。纳入意向治疗分析的患者中,130名来自R-CHOEP-14组,132名来自R-MegaCHOEP组。对这些患者的中位随访时间为42个月,R-CHOEP-14组的3年无事件生存期为69.5%,而在R-MegaCHOEP组为61.4%。所有R-MegaCHOEP组可接受评估的128名患者有4级白细胞减少,R-CHOEP-14组中82名患者(58.5%)血像检查出现相似结果。所有R-MegaCHOEP组可接受评估的128名患者有3-4级的血小板减少,R-CHOEP-14组中26名患者(33.8%)血像检查出现相似结果。对患者而言最重要的非血液学3-4级的副反应为感染,占R-MegaCHOEP组所有患者的75.0%,占R-CHOEP-14组所有患者的31.3%。
    研究结果指出,在年轻的高危侵袭性B细胞淋巴瘤患者中,R-MegaCHOEP方案并不优于常规R-CHOEP方案,并且R-MegaCHOEP方案的毒性反应更多。对于这些患者而言,也可以在R-CHOEP方案上联合放疗可增强疗效。

下载原文:

Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma an open-label, randomised, phase 3 trial (DSHNHL 2002-1).pdf

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    2013-04-11 minlingfeng
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    2013-10-14 howi
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    2012-11-28 sunyl07
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    2012-11-28 yzh402

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