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首页> 外文期刊>Nature clinical practice. Oncology >Is bortezomib active in patients with mantle cell lymphoma?
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Is bortezomib active in patients with mantle cell lymphoma?

机译:硼替佐米在套细胞淋巴瘤患者中活跃吗?

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Mantle cell lymphoma (MCL) has a poor prognosis and most patients relapse despite good response rates to first-line chemotherapy. OBJECTIVE To confirm, in an international multicenter trial, that bortezomib has activity in patients with relapsed or refractory MCL. DESIGN AND INTERVENTION This prospective, phase II, single-arm trial was conducted in 35 centers in the US, UK and Germany between June 2003 and December 2005. Adult patients with pathologically confirmed MCL with evidence of t(11;14)(q13;q32) translocation or over-expression of cyclin D1 who had relapse or disease progression after one or two previous lines of treatment (including rituximab and an anthracycline or mitoxantrone), with disease at one or more measurable or assessable sites, and Karnofsky performance status >50% were included. Bortezomib (1.3mg/m~2) was administered on days 1, 4, 8 and 11 of a 21 -day cycle. Up to 17 cycles, or 4 cycles following complete response (CR) or unconfirmed CR (CRu), were given. Bortezomib was discontinued for progressive disease or serious toxicity, or at the discretion of the patient or investigator.
机译:套细胞淋巴瘤(MCL)的预后较差,尽管对一线化疗的反应率很高,但大多数患者仍会复发。目的在一项国际多中心试验中确认硼替佐米对复发或难治性MCL患者具有活性。设计与干预该前瞻性II期单臂试验于2003年6月至2005年12月在美国,英国和德国的35个中心进行。成人患者经病理证实为MCL,证据为t(11; 14)(q13; q32)先前或经过一两次治疗(包括利妥昔单抗和蒽环类或米托蒽醌)治疗后已复发或疾病进展的细胞周期蛋白D1易位或过表达,且疾病位于一个或多个可测量或可评估的部位,并且卡诺夫斯基的表现>包括50%。在21天周期的第1、4、8和11天服用硼替佐米(1.3mg / m〜2)。给出了最多17个周期,或完全响应(CR)或未确认的CR(CRu)后的4个周期。因进行性疾病或严重毒性或患者或研究者的酌情决定权而停用硼替佐米。

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