Cancer Commun: 抗HER2抗体RC48治疗HER2过表达晚期胃癌(GC)或胃食管交界处癌(GEJA)的疗效和安全性:单臂II期研究

2021-10-23 yd2015 MedSci原创

研究表明,对于既往接受过2线或以上化疗的HER2过表达晚期胃癌或胃食管连接处癌患者,RC48表现出现可观的疗效并且毒性可控。

胃癌(GC)或胃食管交界处癌(GEJA)是全球第五大常见癌症和第四大癌症死亡原因,尤其在中国,发病率为29.3/10万,死亡率为21.2/10万。在约20%的GC患者中,人表皮生长因子受体2 (HER2)过表达(免疫组化[IHC]评分为3+或IHC 2+,荧光原位杂交[FISH]阳性)。基于III期ToGA试验结果,曲妥珠单抗是唯一被批准加入HER2过表达晚期胃癌一线化疗的药物。然而,目前还没有其他抗HER2药物被批准用于二线治疗。

RC48是一种新的重组人抗her2单克隆抗体,通过可剪切连接物与微管抑制剂(单甲基auristatin E)偶联。前期研究结果表明,RC48对多种肿瘤细胞系和HER2表达的动物模型均有较强的抗肿瘤作用。在之前的研究中,RC48对实体肿瘤,特别是胃癌也显示了良好的安全性和有希望的活性,并且对HER2低表达(定义为HER2 IHC 2+并且FISH-)和HER2高表达(定义为HER2 IHC 2+且FISH+或HER2 IHC 3+)肿瘤显示了相同的疗效。为了解决HER2过表达晚期GC患者的治疗需求,来自北京大学肿瘤沈琳教授主导的团队设计了一项单臂II期研究来评估RC48的疗效。相关结果发表在Cancer Communications杂志上。

该研究是一项在中国31家学术医院或癌症中心进行的单臂、开放标记的II期试验。符合条件的患者年龄至少为18岁,预期寿命超过12周;至少接受过2线或以上治疗;组织学证实,局部晚期或转移性GC或GEJA; ECOG为0-1;根据实体瘤反应评估标准(RECIST版本1.1),至少有一个不可切除的、可测量的肿瘤病变;心、肝、肾的功能合适;组织学证实HER2过表达(定义为IHC 3+或2+)主要终点是由独立评审委员会评估的客观缓解率(ORR)。次要终点包括无进展生存期(PFS)、总生存期(OS)、应答时间、进展时间、疾病控制率和安全性。

2018年7月10日至2019年12月6日期间,179名患者接受了评估,其中125名患者为本研究提供了可靠的证据,并接受了至少一剂RC48治疗。截至2020年11月20日,一名患者(0.8%)继续接受RC48治疗。终止治疗最常见的原因是疾病进展(76例,60.8%)和AEs(16例,12.8%)。研究纳入完整分析集125例患者,收集12个月随访数据。中位治疗时间为12.0周(范围2.0 ~ 38.0周),中位随访时间为7.6个月(范围0.8 ~ 23.7月)。在125例患者中,97例(77.6%)为GC, 28例(22.4%)为GEJA;59例(47.2%)曾接受过3线或以上疗程。大部分患者病情较差,仅有29例(23.2%)ECOG评分为0。

所有125例患者均接受2.5mg/kg剂量的RC48单药治疗。IRC评估的总ORR为24.8% (95% CI: 17.5%-33.3%)。中位DOR为4.7个月(95% CI: 3.4-6.9个月), DCR为42.4% (95% CI: 33.6%-51.6%)。

        疗效评估

在IRC评估的基础上计算PFS和TTP。截至2020年11月20日,107名患者(85.6%)报告疾病进展或死亡。中位PFS为4.1个月(95% CI: 3.7-4.9个月),6个月PFS率为26.2%。87例(69.6%)患者出现了TTP事件,如疾病进展或因进展而死亡,中位TTP为4.2个月(95% CI: 3.9-5.4个月;97例患者(77.6%)死亡,中位OS为7.9个月(95% CI: 6.7-9.9个月),1年生存率为33.3% (95% CI:25.0%-41.9%)。

        PFS和OS

亚组分析根据年龄、ECOG功能状态、原发部位、肿瘤结节、转移部位数量、HER2状态、既往曲妥珠单抗治疗、既往紫杉烷治疗、既往治疗行数进行。65岁以上的患者比年轻患者的PFS明显延长(P = 0.044),而其他亚组的ORR、PFS或OS结果均无显著获益。

所有患者均报告至少1例AE。最常见的AEs包括白细胞(WBC)计数下降(53.6%)、乏力(53.6%)、脱发(53.6%)、中性粒细胞计数下降(52.0%)、贫血(49.6%)和天冬氨酸转氨酶(AST;43.2%)。40例(32.0%)患者出现3-5级RC48相关AEs,其中以中性粒细胞计数减少(14.4%)、白细胞计数减少(14.4%)、贫血(5.6%)最为常见。

         不良事件

综上,研究表明,对于既往接受过2线或以上化疗的HER2过表达晚期胃癌或胃食管连接处癌患者,RC48表现出现可观的疗效并且毒性可控。

原始出处:

Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Oct 19. doi: 10.1002/cac2.12214. Epub ahead of print. PMID: 34665942.

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    2022-02-08 lq1767
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    2022-04-06 ms7000000949589415

    持续学习

    0

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    2022-09-25 liuli5079
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    2021-10-25 zhouqu_8
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    2021-10-24 ms2000000182667314

    学到了

    0