Lancet:徐瑞华团队研究为亚洲晚期肠癌患者提供新的二线化疗标准方案,改写国际指南

2018-03-19 王梓贤、王峰 肿瘤资讯

中山大学附属肿瘤医院徐瑞华教授领衔的中日韩研究者团队开展了一项改良的双药联合方案(卡培他滨+伊立替康,简称XELIRI)治疗晚期结直肠癌的国际多中心III期临床试验——AXEPT研究(研究号NCT01996306),首次证实该疗法有效且耐受性良好。研究结果于近日在全球顶级肿瘤学杂志《柳叶刀肿瘤》在线发表(最新影响因子33.9分)

中山大学附属肿瘤医院徐瑞华教授领衔的中日韩研究者团队开展了一项改良的双药联合方案(卡培他滨+伊立替康,简称XELIRI)治疗晚期结直肠癌的国际多中心III期临床试验——AXEPT研究(研究号NCT01996306),首次证实该疗法有效且耐受性良好。研究结果于近日在全球顶级肿瘤学杂志《柳叶刀肿瘤》在线发表(最新影响因子33.9分)

肠癌流行病学和治疗现状

近10年我国结直肠癌的发病率呈明显上升趋势。我国城市人口2015年新发结直肠癌病例数达 26 万人,在所有恶性肿瘤中高居第5位。结直肠癌起病隐匿,我国肠癌早期确诊的比例仅为5%~10%。早期结直肠癌可以通过手术治愈, 5 年生存率可达90%, 而晚期结直肠癌5 年生存率则不足 10%。对于不可手术治愈的晚期结直肠癌,全身性化疗为首选治疗手段。

肠癌现有的化疗方案的局限性

对于晚期结直肠癌患者,基于氟尿嘧啶和伊立替康的双药联合化疗方案(简称FOLFIRI)是目前国际指南推荐的标准化疗方案之一。然而,该方案需进行每两周一次、长达46小时的输液,并且治疗前患者需接受中心静脉插管的手术,应用极为不便。

卡培他滨是一种新型的化疗药物,其活性成分与氟尿嘧啶相同,但为口服用药(每三周为一周期)。与FOLFIRI方案相比,卡培他滨联合伊立替康的XELIRI方案只需每三周进行一次2~3小时的输液,且治疗前无需进行插管手术,应用更为方便。然而,既往欧美的临床研究发现, XELIRI方案在欧美人群中的毒性非常大,因而该方案未被国际指南采纳。

大胆的科学设想

既往有研究表明亚洲人群与欧美人群之间对XELIRI方案的耐受性存在差异。因此,徐瑞华教授大胆地提出了科学设想:对于亚洲人群,适当降低剂量的XELIRI方案可能同时带来毒性的减低以及疗效的增益。基于该设想,徐瑞华教授与韩国峨山医院Tae Won Kim(金泰万)教授、日本爱知县肿瘤医院Kei Muro(室圭)教授带领的由98家中心组成的中日韩研究团队开展了关于改良的XELIRI方案的大型III期AXEPT研究。

新方案有效且低毒

AXEPT研究耗时3年余(2013年12月~2017年6月),共招募及入组650名一线化疗失败的晚期结直肠癌患者。研究结果显示,接受改良的XELIRI方案的患者,平均生存期达到17个月,不劣于、甚至超过了接受FOLFIRI方案的患者的平均生存期(15个月)。此外,与FOLFIRI方案相比,改良的XELIRI方案的不良反应发生率大幅度降低(从72%降低至54%),其中血液学毒性(如白细胞减少等)的发生率更是降低一半以上(从45%下降至20%)。


新方案有望成为肠癌化疗新标准

随着晚期结直肠癌患者的生存期不断延长,如何提高这类患者的生活质量也日益受到重视。AXEPT研究首次证实,改良的XELIRI方案的疗效与国际标准的FOLFIRI方案相当,且耐受性更好,应用更为方便。在《柳叶刀肿瘤》同期发表的述评中,澳大利亚阿德莱德大学伊丽莎白医院的Timothy Price教授指出,“基于口服药的化疗方案能使治疗简化。AXEPT是国际上首个对比改良的XELIRI方案与FOLFIRI方案的大型随机对照3期研究。基于该研究的结果,改良的XELIRI方案将有望替代FOLFIRI方案成为晚期结直肠癌的新的标准化疗方案,改变现有的临床实践。”在该研究结果公布后不久,亚洲结直肠癌指南就已将其采纳。

在AXEPT研究开展期间,中日韩的主要研究者共进行了9次学术委员会会议,通过会面洽谈反复探讨项目实施的各个环节中遇到的问题及提出解决方案。AXEPT研究的成功无疑为我国临床研究的开展提供了宝贵的经验,展示了我国先进中心的临床研究水平已与国际一流中心接轨。伴随着综合国力的不断提升,我国优秀临床研究团队也逐渐获得国际承认,开始登上国际学术舞台。
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    2018-12-18 仁医06
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    2018-03-24 大爰

    学习了谢谢分享!!

    0

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    2018-03-23 zb1235672

    好消息.值得学习

    0

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    2018-03-22 zb1235672

    好消息.值得学习

    0

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    2018-03-19 139****5926

    好好文章学习了

    0

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