Clin cancer res:FTD/TPI+伊立替康+贝伐单抗联合治疗晚期消化道肿瘤的疗效和安全性

2020-04-06 QQY MedSci原创

FTD/TPI+伊立替康+贝伐单抗联合治疗转移性结直肠癌(mCRC)的安全性、药物动力学和FTD抗肿瘤活性目前尚不明确。

目的:明确trifluridine(三氟尿苷)/tipiracil (FTD/TPI)和伊立替康联合治疗晚期消化道肿瘤患者的最大耐受剂量(MTD),同时评估FTD/TPI+伊立替康+贝伐单抗联合治疗转移性结直肠癌(mCRC)的安全性、药物动力学和FTD抗肿瘤活性。

方法:本试验是一个Ib期临床试验,分为两个部分:剂量递增阶段(3+3设计),晚期胃肠道肿瘤患者接受FTD/TPI(每疗程的前5天,20-35mg/m2,2次/日,14天/疗程)和伊立替康(第1天,120–180mg/m2)。剂量扩增阶段,mCRC患者接受最大耐受剂量的FTD/TPI和伊立替康联合贝伐单抗(第1天,5mg/kg)。

结果:共招募了50位患者:26位分至6个剂量递增队列,24位分至剂量扩增阶段。在剂量递增阶段观察到2例剂量限制性毒性作用(疲劳和中性粒细胞减少),FTD/TPI的MTD为25mg/m2(2次/日)联合伊立替康 180mg/m2。在剂量扩增阶段,83%(20/24)的患者发生过任何原因的3级及以上的不良反应(AEs),最常见的是中性粒细胞减少(42%)、白细胞减少(25%)和腹泻(12%),分别导致29%、17%、4%的患者的给药中断、修改和终止。无治疗相关死亡。3位(12%)患者获得部分缓解,16位(67%)患者病程稳定持续超过4个月。中位无进展存活期为7.9个月。

结论:在本I期试验中,耐受性和疗效结果支持进一步在既往治疗过的mCRC患者中评估FTD/TPI+伊立替康+贝伐单抗联合方案的应用价值。

原始出处:

Anna M. Varghese, et al. Phase I Study of Trifluridine/Tipiracil Plus Irinotecan and Bevacizumab in Advanced Gastrointestinal Tumors. Clinical Cancer Research. April 2020. DOI: 10.1158/1078-0432.CCR-19-2743

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    2020-09-20 mhm299
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    2020-04-06 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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既往研究表明非小细胞肺癌(NSCLC)患者可从维持治疗中获益。COMPASS试验评估了贝伐单抗联合或不联合培美曲塞作为卡铂+培美曲塞和贝伐单抗诱导化疗后的维持治疗的有效性和安全性。COMPASS试验招募明确无EGFR 19缺失或L858R突变的未治疗过的晚期非鳞状NSCLC患者,予以卡铂、培美曲塞(500mg/m2)和贝伐单抗(15mg/kg)作为一线治疗,每3周用药一次,共4个疗程。在诱导治疗过