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Lancet:依鲁替尼 vs 替西罗莫司治疗套细胞淋巴瘤

2015-12-07 Mechront 译 MedSci原创

套细胞淋巴瘤是具有侵袭性的B细胞淋巴瘤,预后极差。依鲁替尼和替西罗莫司对复发或难治性套细胞淋巴瘤患者单独使用时具有一定效果。研究者进行了一项3期试验,探究对该类患者使用依鲁替尼 vs 替西罗莫司的有效性和安全性。该随机多中心的3期临床试验纳入了涉及21个国家确诊为套细胞淋巴瘤,接受至少一次含利妥昔单抗的治疗患者。根据先前治疗、简化套细胞淋巴瘤国际预后指数得分对患者进行分层,随机分为每日口服依鲁替尼

套细胞淋巴瘤是具有侵袭性的B细胞淋巴瘤,预后极差。依鲁替尼和替西罗莫司对复发或难治性套细胞淋巴瘤患者单独使用时具有一定效果。研究者进行了一项3期试验,探究对该类患者使用依鲁替尼vs替西罗莫司的有效性和安全性。

该随机多中心的3期临床试验纳入了涉及21个国家确诊为套细胞淋巴瘤,接受至少一次含利妥昔单抗的治疗患者。根据先前治疗、简化套细胞淋巴瘤国际预后指数得分对患者进行分层,随机分为每日口服依鲁替尼560 mg或静脉注射替西罗莫司(第1天、第8天和第15天使用175mg,21天为一个周期;接着第1天、第8天和第15天使用75mg)。初始结局指标是无进展生存期;实验前研究者假设依鲁替尼与替西罗莫司相比,可更显著改善无进展生存期。

该研究于2012年12月10日-2013年和11月26日,共纳入了280名患者,其中依鲁替尼组139人,替西罗莫司组有141人。研究数据显示,依鲁替尼组无进展生存期显著优于替西罗莫司组 (HR 0·43 [95% CI 0·32–0·58],p<0·0001;中位数无进展生存期依鲁替尼组 vs 替西罗莫司组:14·6 个月 [95% CI 10·4– ] vs 6·2 个月 [4·2–7·9])。并且患者对依鲁替尼的耐受性更好,3级或以上与治疗相关的紧急不良事件在依鲁替尼组和替西罗莫司组分别为94(68%)名患者和121(87%)名患者。终止服药情况在依鲁替尼组也更少,依鲁替尼组和替西罗莫司组分别为9[6%]名患者和36[26%]名患者。

研究结果表明,对复发或难治性套细胞淋巴瘤患者,使用依鲁替尼治疗与替西罗莫司相比,可显著改善患者无进展生存期,且患者耐受性更佳。研究数据可进一步支持依鲁替尼在对上述患者进行治疗时利大于弊。

原始出处:

Martin Dreyling, Wojciech Jurczak, et al.Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study.The Lancet.Published online: December 7, 2015

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    2017-11-15 1209e435m98(暂无昵称)

    内容很新.学习了!

    0

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    2016-06-08 howi
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    2015-12-27 hixiaoluo

    好文章,值得收藏

    0

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