西达本胺治疗外周T细胞淋巴瘤中国专家共识（2016版）共识发布

2016-05-20 肿瘤瞭望转自《肿瘤瞭望》

编者按：5月13日下午，由中国临床肿瘤学会（CSCO）、中国抗淋巴瘤联盟（UCLI）、中华医学会血液学分会（CSH）白血病-淋巴瘤学组、中国抗癌协会血液肿瘤专业委员会、中国抗癌协会淋巴瘤专业委员会共同参与制定的《西达本胺治疗外周T细胞淋巴瘤中国共识（2016版）》于北京发布。发布会由中国抗淋巴瘤联盟主席马军教授和上海交通大学附属瑞金医院的沈志祥教授主持，中国医学科学院石远凯教授、北京大学肿瘤医院朱

编者按：5月13日下午，由中国临床肿瘤学会（CSCO）、中国抗淋巴瘤联盟（UCLI）、中华医学会血液学分会（CSH）白血病-淋巴瘤学组、中国抗癌协会血液肿瘤专业委员会、中国抗癌协会淋巴瘤专业委员会共同参与制定的《西达本胺治疗外周T细胞淋巴瘤中国共识（2016版）》于北京发布。发布会由中国抗淋巴瘤联盟主席马军教授和上海交通大学附属瑞金医院的沈志祥教授主持，中国医学科学院石远凯教授、北京大学肿瘤医院朱军教授等编写组专家分享了西达本胺注册临床（CHIPEL）研究数据、上市后应用数据分析，专家共识的主要内容、要点解读、并对西达本胺的临床研究进展进行全面解读。与会专家就如何使用好西达本胺结合自己的临床经验进行了深入的讨论。

西达本胺CHIPEL研究及上市后主动监测数据——石远凯教授

石远凯教授首先介绍了西达本胺治疗复发或难治性外周T细胞淋巴瘤（PTCL）的关键性II期临床试验（CHIPEL试验）。该试验是多中心、开放性试验，全国有15家医院的淋巴瘤和血液临床研究中心参与此项研究。给药方案是30mg每周口服2次。独立委员会评价疗效ORR达到28%，其中缓解率最高的是血管免疫母细胞T细胞淋巴瘤，ORR为50%。46%患者6周临床收益（CR+PR+SD），此部分患者中位OS达到55个月。对比国外目前现有针对复发/难治性外周T患者二线治疗方案（包括化疗、普拉曲沙、罗米地辛、贝利司他），西达本胺的总体中位OS为21.4个月，优于其它方案。2015年版的中国恶性淋巴瘤诊疗规范就已将西达本胺列入治疗外周T细胞淋巴瘤的二线方案。

西达本胺上市后，截止2016年2月收集的383例有完整记录的PTCL患者数据。上市后以单药治疗为主，占2/3，另有1/3为联合治疗。单药的客观缓解率达到39%，联合用药的客观缓解率明显提升，达到51%。进一步分析提示，对于中高危的患者，含西达本胺的联合治疗可提高疗效，但合并使用化疗方案时应该注意两者不良反应。

图1. CHIPEL研究总体疗效

西达本胺治疗外周T细胞淋巴瘤中国共识——朱军教授

北京大学肿瘤医院的朱军教授向与会专家详细解读了该共识的核心内容。

西达本胺在上市后临床应用中已确认其单药疗效，目前临床很多专家也在探索更优疗效的方案，有多项西达本胺联合用药治疗PTCL的临床研究正在进行中，基本覆盖了目前常见的一线及二线方案。共识中针对不同类型患者的单药或联合用药做了临床应用的建议（图2）。其中不能耐受常规化疗的PTCL患者，也包括不能耐受一线化疗的患者，可选择单药作为一线治疗。西达本胺治疗单药治疗最常见的不良反应包括中性粒细胞、血小板减少及贫血。

图2. 共识中治疗PTCL的临床应用建议

西达本胺全球临床开发&中国上市后临床试验进展——宁志强博士

深圳微芯生物科技有限责任公司的宁志强博士介绍了西达本胺的全球临床开发情况。西达本胺目前在中国的临床开发计划包括针对首类适应症的单药临床试验研究（PTCL、CTCL）及以实体瘤为适应症开展的联合用药试验研究（非小细胞肺癌、乳腺癌）。他介绍了一项日本已完成的针对非霍奇金氏淋巴瘤（NHL）的I期临床试验。入组11例病人， 1例达到完全缓解（CR），5例达到部分缓解（PR）。此外还简要介绍了正在日本、韩国及美国开展的多项研究计划，机制研究等。西达本胺抗肿瘤的作用机制，包括增强NK及CTL的细胞杀伤活性、促进肿瘤细胞的抗原暴露以及下调免疫抑制剂Foxp3、IDO等的表达。西达本胺与靶向药物及免疫治疗药物的联用也正在研究中。

到会专家结合临床试验数据和临床使用经验，展开了深入讨论。大家普遍认为，截止目前接受西达本胺治疗的PTCL患者多为既往多次治疗失败的晚期患者，相比于早期复发患者，此类晚期复发患者疗效差，不良反应发生率高，因此在今后临床实践中，建议尽量选择早期复发患者推荐使用单药或联合治疗，即“二线首选”；也可诱导缓解后用作维持治疗。西达本胺的总体不良反应的发生率明显低于化疗，因此可作为长期口服维持治疗。联合GDP或CHOP时需要酌情减量，减少安全性问题发生率。沈志祥教授同时表示希望在尽快推进临床试验的同时及时公布结果。应建议患者在一线治疗缓解后进行维持治疗，虽然目前还没有循证医学证据，但也值得探索，维持时间经验性暂定6-12个月，根据研究进展再予以调整。

沈教授和马军教授总结指出《西达本胺治疗PTCL的中国专家共识（2016版）》发布是我国外周T细胞淋巴瘤（PTCL）治疗史上的一个里程碑，为PTCL的治疗开启了新的篇章，为PTCL患者的治疗提出了更多的解决方案。希望通过规范临床实践的应用和多项探索性临床研究方案的推进，有更多临床数据分析和循证医学证据指导PTCL疗效的进一步提升，更多患者获益，共识也将再此基础上不断发展更新。

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2016-11-02 zhaojie88

#中国专家共识#

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2016-09-30 1e10c84am36(暂无匿称)

拜读，好文

0 0
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2016-12-17 marlenexl

#细胞淋巴瘤#

82 0
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2016-07-31 snowpeakxu

#专家共识#

57 0
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2016-05-22 Kiste

跟异基因移植哪个好

201 0
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2016-05-22 xlxchina

#外周T细胞淋巴瘤#

70 0
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2016-05-22 aliceclz

#T细胞淋巴瘤#

64 0
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2016-05-20 jetleo

外周T细胞淋巴瘤（PTCL）治疗

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中国原创抗癌新药面世研发过程堪比“走钢丝”