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阿仑单抗巩固治疗可改善初治缓解期慢性淋巴细胞白血病(CLL)患者的无进展生存期:德国CLL研究组(GCLLSG)一项随机III期试验的长期随访结果

Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG).

作者信息

Schweighofer Carmen D, Ritgen Matthias, Eichhorst Barbara F, Busch Raymonde, Abenhardt Wolfgang, Kneba Michael, Hallek Michael, Wendtner Clemens-Martin

机构信息

Department of Internal Medicine I, University of Cologne, Cologne, Germany.

出版信息

Br J Haematol. 2009 Jan;144(1):95-8. doi: 10.1111/j.1365-2141.2008.07394.x. Epub 2008 Oct 30.

DOI:10.1111/j.1365-2141.2008.07394.x
PMID:19016732
Abstract

Alemtuzumab has shown considerable activity in untreated and relapsed chronic lymphocytic leukaemia. We report our long-term experience in 21 patients within a randomized phase III trial investigating the role of alemtuzumab for consolidation therapy after first-line fludarabine +/- cyclophosphamide, which was stopped prematurely due to severe infections. However, after a median follow-up of 48 months, progression-free survival was significantly prolonged for patients receiving alemtuzumab consolidation compared to those with no further treatment (P = 0.004). Minimal residual disease (MRD) levels were persistently reduced after consolidation. Therefore, despite toxicity, MRD reduction by alemtuzumab consolidation translates into a significantly improved long-term clinical outcome.

摘要

阿仑单抗在未经治疗和复发的慢性淋巴细胞白血病中已显示出显著活性。我们报告了在一项随机III期试验中对21例患者的长期经验,该试验研究阿仑单抗在一线氟达拉滨+/-环磷酰胺治疗后巩固治疗中的作用,该试验因严重感染而提前终止。然而,在中位随访48个月后,与未接受进一步治疗的患者相比,接受阿仑单抗巩固治疗的患者无进展生存期显著延长(P = 0.004)。巩固治疗后微小残留病(MRD)水平持续降低。因此,尽管存在毒性,但阿仑单抗巩固治疗使MRD降低转化为显著改善的长期临床结局。

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Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG).阿仑单抗巩固治疗可改善初治缓解期慢性淋巴细胞白血病(CLL)患者的无进展生存期:德国CLL研究组(GCLLSG)一项随机III期试验的长期随访结果
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