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在 IFM 2005-01 试验中,诱导治疗达到 VGPR 是无进展生存期延长的重要预后因素。

Achievement of VGPR to induction therapy is an important prognostic factor for longer PFS in the IFM 2005-01 trial.

机构信息

University Hospital, Nantes, France.

出版信息

Blood. 2011 Mar 17;117(11):3041-4. doi: 10.1182/blood-2010-08-300863. Epub 2010 Nov 23.

Abstract

In the 2005-01 trial, we have demonstrated that bortezomib-dexamethasone as induction therapy before autologous stem cell transplantation was superior to vincristine-adriamycin-dexamethasone. We conducted a post-hoc analysis to assess the prognostic impact of initial characteristics as well as response to therapy in patients enrolled in this study. Multivariate analysis showed that ISS stages 2 and 3 and achievement of response less than very good partial response (VGPR) both after induction therapy and after autologous stem cell transplantation were adverse prognostic factors for progression-free survival, the most important one being achievement of response less than VGPR after induction. Progression-free survival was significantly improved with bortezomib-dexamethasone induction therapy in patients with poor-risk cytogenetics and ISS stages 2 and 3 compared with vincristine-adriamycin-dexamethasone. In these 2 groups of patients, achievement of at least VGPR after induction was of major importance. This study is registered with EudraCT (https://eudract.ema.europa.eu; EUDRACT 2005-000537-38) and http://clinicaltrials.gov (NCT00200681).

摘要

在 2005-01 试验中,我们已经证明硼替佐米-地塞米松作为自体干细胞移植前的诱导治疗优于长春新碱-阿霉素-地塞米松。我们进行了一项事后分析,以评估该研究中入组患者的初始特征和对治疗的反应对预后的影响。多变量分析显示,诱导治疗后和自体干细胞移植后均未达到非常好的部分缓解(VGPR)的国际分期系统(ISS)分期 2 和 3 以及缓解程度低于 VGPR 是无进展生存期的不良预后因素,其中最重要的是诱导后缓解程度低于 VGPR。与长春新碱-阿霉素-地塞米松相比,硼替佐米-地塞米松诱导治疗可显著改善细胞遗传学不良风险和 ISS 分期 2 和 3 的患者的无进展生存期。在这两组患者中,诱导后达到至少 VGPR 是非常重要的。这项研究在 EudraCT(https://eudract.ema.europa.eu;EUDRACT 2005-000537-38)和 http://clinicaltrials.gov(NCT00200681)上注册。

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