Br J Cancer:FOLFIRI治疗方案与西妥昔单抗或贝伐单抗联合治疗晚期结直肠癌的FIRE-3 3期随机临床研究

2020-11-16 xiaozeng MedSci原创

既往研究显示,转移性结直肠癌(mCRC)患者在接受多模式治疗,并将该治疗策略作为一线治疗和后续治疗连续治疗策略的一部分,患者的中位生存时间可以达到30个月或更长。

既往研究显示,转移性结直肠癌(mCRC)患者在接受多模式治疗,并将该治疗策略作为一线治疗和后续治疗连续治疗策略的一部分,患者的中位生存时间可以达到30个月或更长。

FIRE-3研究(AIO KRK-0306)是一项随机的、非盲的3期临床试验,该试验比较了将西妥昔单抗(cetuximab)和贝伐单抗(bevacizumab)与一线化疗药物5-氟尿嘧啶、亚叶酸和伊立替康(FOLFIRI治疗方案)联用时的疗效。


研究过程中已证实,RAS突变会直接影响到EGFR(表皮生长因子受体)抑制剂的疗效。而在KRAS野生型mCRC患者中,相比于贝伐单抗+FOLFIRI联合治疗,西妥昔单抗+FOLFIRI联合治疗的患者总体生存期显著变长,并未发现无进展生存期的差异性。

RAS野生型患者的存活时间分析

该研究旨在确定在接受一线FOLFIRI治疗的可评估反应的RAS野生型mCRC患者中,西妥昔单抗的联合治疗相比于贝伐单抗联合治疗是否会改善患者的药物响应和生存率,以及对于原发性肿瘤预后的影响。


该研究的意向性治疗人群包括593例KRAS第2外显子野生型的mCRC患者。进一步检测确定了其中的400名RAS野生型患者;在这些患者中,有352名(88%)接受了≥3个疗程的治疗,且进行了≥1次的基础值后测定,以评估患者的应答率,构建了按方案接受治疗的分组(西妥昔单抗169名和贝伐单抗183名)。患者在每个14天周期的第1天接受FOLFIRI治疗并结合每周一次的西妥昔单抗治疗或每两周一次的贝伐单抗,直到出现应答,病情进展或药物毒性。主要终点是符合方案集分析的的客观缓解率(ORR)。次要终点包括总体生存期(OS)和无进展生存期(PFS)。同时评估了原发肿瘤位置的影响。

RAS野生型患者的原发肿瘤位置与生存时间分析

结果显示,西妥昔单抗组和贝伐单抗组患者的中位OS分别为31个月和26个月。符合方案集分析的西妥昔单抗组的ORR更高(77%vs 65%)且中位OS更长(33个月 vs 26个月),而两组之间的PFS相当。研究人员还发现,西妥昔单抗优于贝伐单抗的优势仅出现在于左侧原发性肿瘤患者。


综上,该研究发现,相比于贝伐单抗+FOLFIRI联合治疗,西妥昔单抗+FOLFIRI联合治疗对于左侧肿瘤患者具有显著的更高的客观缓解率和更长的总体生存期。而这一西妥昔单抗优越反应或有益于有症状肿瘤或临界可切除转移的患者。

 

原始出处:

Heinemann, V., von Weikersthal, L.F., Decker, T. et al. FOLFIRI plus cetuximab or bevacizumab for advanced colorectal cancer: final survival and per-protocol analysis of FIRE-3, a randomised clinical trial. Br J Cancer (06 November 2020).

 

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  5. 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    2020-12-05 ms3000001695435295

    不错不错

    0

  6. 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  7. 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  9. 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    2020-11-16 肿瘤克星

    高质量研究,读起来真爽,谢谢梅斯

    0

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