Front Oncol:真实世界中曲妥珠单抗生物仿制剂CT-P6在HER2阳性早期(EBC)和转移性乳腺癌(MBC)患者中的疗效

2021-10-23 yd2015 MedSci原创

真实世界数据表明,曲妥珠单抗生物仿制剂CT-P6在HER2阳性EBC和MBC患者中具有与RTZ相似的有效性和心脏安全性。

乳腺癌是一种异质性疾病,有多个亚型。大约25%的乳腺癌中人表皮生长因子受体2 (HER2)扩增,导致更具侵袭性的表型,预后较差。曲妥珠单抗,人单克隆抗体,改变了her2阳性乳腺癌的治疗格局,改善了临床应答和无病生存率。曲妥珠单抗在转移性her2阳性乳腺癌中也有效,在标准化疗中加入曲妥珠单抗可以延长总生存期(OS)。一些曲妥珠单抗生物仿制药已经开发出来,包括CT-P6。2018年,CT-P6获美国食品和药物管理局和欧洲药品管理局批准,用于治疗her2阳性早期(EBC)和转移性乳腺癌(MBC)。近期,韩国学者开展了相关研究, 评估CT-P6或曲妥珠单抗(RTZ)与帕妥珠单抗联合化疗在her2阳性EBC患者的新辅助治疗中或在MBC患者的姑息一线治疗中有效性。相关结果发表在Frontiers in Oncology杂志上。

研究回顾性调查了韩国Severance乳腺癌登记处的医疗记录。筛选2014年5月至2019年12月期间接受RTZ或CT-P6加帕妥珠单抗、卡铂和多西他赛(TCHP)新辅助化疗的her2阳性EBC患者(n=254)和未经治疗的IV期MBC患者(n=103)。主要终点是EBC的病理完全缓解(pCR)和MBC队列的无进展生存(PFS)。总生存率(OS)、总缓解率(ORR)、疾病控制率(DCR)和心脏安全性是次要终点。

254例HER2阳性EBC患者进行了分析。接受CT-P6治疗的患者(n=125, 49.2%)和接受RTZ治疗的患者(n=129, 50.8%)基线特征相似。CT-P6治疗患者的Ki67指数≥14的比例较高 (CT-P6: 87.5% [84/125];RTZ: 70.5% (55/129);P = 0.005)。倾向评分校正后,CT-P6和RTZ组之间的所有变量都很平衡。

103例患者HER2阳性MBC进行了分析。接受CT-P6(38例,36.9%)和RTZ(65例,63.1%)的患者的基线特征相似。在CT-P6中,新发IV期MBC患者的百分比为63.2%(24/38),而接受RTZ的患者中为72.3%(47/65)。最常见的转移部位是远处淋巴结,其次是骨、肺和肝。

对于EBC患者,两组间获得pCR的百分比没有差异。总体而言, CT-P6组的74.4%(93/125)患者获得pCR,而RTZ组的69.8%(90/129)患者获得pCR (P=0.411)。在HR阳性EBC患者中,接受CT-P6治疗的患者中有57.8%(26/45)达到pCR,而接受RTZ治疗的患者中有44.4%(20/45)达到pCR (P=0.206)。在HR阴性患者中,接受CT-P6治疗的患者中有83.8%(67/80)达到pCR,接受RTZ治疗的患者中有83.3%(70/84)达到pCR (P=0.943)。同样,在PSM队列中,无论亚型如何,两组之间的pCR也没有差异。

          pCR

接受CT-P6和RTZ治疗的MBC患者中位随访时间(范围)分别为23.0(3.0-36.0)和41.0(1.0-83.0)个月。接受CT-P6治疗的中位周期数(范围)为23.0(3-54)个周期,而RTZ组中位周期数(范围)为26.0(1-99)个周期。两组间中位无进展生存时间无显著差异(CT-P6 vs RTZ: 13.0 vs 18.0个月[95% CI 0.0-26.6 vs 11.3-24.7];P = 0.976)。无论HR状态如何,两组间的中位PFS差异也无统计学意义(HR阳性:CT-P6 vs RTZ 10.0 vs 17.0个月[95% CI 0.0-23.7 vs 10.0-24.0], P=0.721;HR阴性:13.0 vs 21.0个月[95% CI NA vs 12.9-29.1], P=0.875)。无论HR状态如何,CT-P6组和RTZ组的mOS也没有显著差异(未达到vs未达到,P=0.330)。

         MBC患者的预后

两组的ORR和DCR也无显著差异(ORR: CT-P6 vs RTZ 78.9% vs 83.1%,P=0.602;DCR: 94.7% vs 93.8%,P>0.999)。

         MBC的疗效评估

在EBC队列中,两组治疗前LVEF率没有差异(平均[95% CI] LVEF: CT-P6: 68.1 [60.7 - 69.1] vs RTZ: 68.1% [67.1-69.1];P = 0.983)或新辅助治疗后也没差异(CT-P6: 65.9% [65.0-66.8] vs RTZ: 66.5% [65.3-67.7];P=0.424)。新辅助化疗后,CT-P6组中23/104例患者(22.1%) LVEF较基线下降≥10个百分点,而RTZ组为13/90 (14.4%)(P=0.171)。两组患者的LVEF在任何时候都没有下降到低于50%。

在MBC队列中,CT-P6和RTZ均显示了可管理的心脏安全状况,通过LVEF进行评估。CT-P6组38例患者中有19例(50.0%)的LVEF较基线下降≥10个百分点,而RTZ组为27/63例(42.9%)(P=0.695)。在接受CT-P6治疗的患者中,3/38(7.9%)的患者在任何时候LVEF下降到小于50%。其中1例患者停用CT-P6 1个月后重新开始;其余患者继续治疗,3个月后因病情进展停止治疗。在接受RTZ治疗的患者中,有4/65(6.2%)例的LVEF在任何时候下降到小于50%。其中2例患者停用RTZ治疗,1例停用1个月后重新开始治疗,另1例继续使用RTZ治疗。

综上,真实世界数据表明,曲妥珠单抗生物仿制剂CT-P6在HER2阳性EBC和MBC患者中具有与RTZ相似的有效性和心脏安全性。

原始出处:

Bae SJ, Kim JH, Ahn SG, Jeung H-C, Sohn J, Kim GM, Kim MH, Kim SI, Park S, Park HS, Kim JY and Jeong J (2021) Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer. Front. Oncol. 11:689587. doi: 10.3389/fonc.2021.689587

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    2021-10-23 老兔

    学习了

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1866309, encodeId=c04c186630961, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Mar 20 22:36:03 CST 2022, time=2022-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648190, encodeId=4933164819096, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Feb 26 18:36:03 CST 2022, time=2022-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295344, encodeId=81b71295344c7, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Mon Oct 25 05:36:03 CST 2021, time=2021-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1308608, encodeId=1b5613086086e, content=<a href='/topic/show?id=240f8e3234' target=_blank style='color:#2F92EE;'>#HER2阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8732, encryptionId=240f8e3234, topicName=HER2阳性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8409354, createdName=闆锋旦, createdTime=Mon Oct 25 05:36:03 CST 2021, time=2021-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386859, encodeId=0c2a1386859c7, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Mon Oct 25 05:36:03 CST 2021, time=2021-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063198, encodeId=9b771063198c8, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=98015645570, createdName=老兔, createdTime=Sat Oct 23 17:01:48 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063193, encodeId=1abd106319360, content=认真学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Sat Oct 23 16:02:41 CST 2021, time=2021-10-23, status=1, ipAttribution=)]
    2021-10-23 医鸣惊人

    认真学习了。

    0