The Oncologist:Palbociclib联合内分泌治疗HR+/HER2-转移性乳腺癌的安全性分析:来自PALOMA系列5年随访综合分析更新

2021-05-15 yd2015 MedSci原创

通过5年的长期综合分析,证实Palbociclib联合内分泌治疗HR+/HER2-转移性乳腺癌是一种安全的治疗方式。

Palbociclib是一种细胞周期蛋白依赖性激酶(CDK)4/6抑制剂,与内分泌(ET)联合治疗批准用于治疗激素受体阳性(HR)/人表皮生长因子受体2阴性(HER2−)晚期乳腺癌(ABC)患者。在PALOMA系列(PALOMA-1,PALOMA-2和PALOMA-3)临床研究中,Palbociclib联合来曲唑或氟维司群较单药来曲唑或氟维司群改善HR+/HER2-转移性乳腺癌患者的无进展生存期(PFS)。虽然中生存期(OS)没有获得统计学差异,但是数值上Palbociclib联合来曲唑或氟维司群获得较长的OS。除了关注患者获得生存外,还有关注治疗相关不良事件以及生活质量。因为在真实世界中,CDK4/6 抑制剂可增加间质性肺炎和静脉血栓形成,而后者可导致更差的PFS和 OS。近期,The Oncologist杂志发表了Palbociclib治疗安全性的数据更新(基于PALOMA系列研究)。

文章更新了PALOMA系列研究中综合分析Palbociclib联合治疗5年随访安全性。数据截止时间:PALOMA-1:2017年12月21日;PALOMA-2:2017年5月31日;PALOMA-3:2018年4月13日。研究数据表明,Palbociclib联合内分泌每年治疗人次为1,421.6(n=872),而内分泌单药为528.4 (n = 471)。Palbociclib联合内分泌组中,36%患者治疗超过24个月,22.4%患者超过36个月,1.7%患者治疗超过48个月,0.7%患者治疗超过60个月,大部分患者是来自PALOMA-2试验。内分泌单药组中,20.2%患者治疗超过24个月,10.2%患者超过36个月,0.8%患者治疗超过48个月,0.4%患者治疗超过60个月。联合组中中位治疗持续时间为14.8个月 (范围: 0–84.4) ,而内分泌单药组为2.9个月 (范围: 0–74.7) 。

              治疗持续时间对比

Palbociclib联合内分泌组发生任何级别粒细胞减少和感染分别为82.1% 和59.2%, 而内分泌单药组分别为5.1% 和 39.5%。3/4级感染的危险比为1.6(p=0.0995),3/4级病毒性感染危险比为1.8 (p = .4358) ,感染的危险比为1.4 (p = .0001) ,中性粒细胞减少危险比为30.8 (p < .0001)。Palbociclib联合内分泌组发生发热性粒细胞减少比例为1.4%。两组任何级别的血液性不良事件在治疗的第一年达到顶峰,在随后的5年治疗中较平稳。Palbociclib联合内分泌组发生间质性肺炎有13例患者,而内分泌单药治疗中有3例患者。

                 内分泌治疗不良事件

                  联合或单药治疗相关不良事件

综上,通过5年的长期综合分析,证实Palbociclib联合内分泌治疗HR+/HER2-转移性乳腺癌是一种安全的治疗方式。

原始出处:

Richard S Finn , Hope S Rugo , Karen A Gelmon,et al. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755.doi: 10.1002/onco.13684. 

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    2022-03-08 minlingfeng
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    2021-05-16 luwei00
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  4. 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  5. 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    2021-06-09 西红柿子首富

    学习学习一下

    0

  6. 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  7. 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style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Mon May 17 13:59:00 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966190, encodeId=16c796619047, content=激素阳性的乳腺癌,采用CDK4/6联合内分泌治疗值得期待,希望价格患者可以承受, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210425/188bc6472a1742d09222864964fb4cca/508399781e704ed38acfdf86b724aef5.jpg, createdBy=d0e75483900, createdName=tjlyp, createdTime=Mon May 17 09:03:02 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038294, encodeId=627b103829431, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 16 01:59:00 CST 2021, time=2021-05-16, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1866090, encodeId=cd8818660909d, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Mar 08 04:59:00 CST 2022, time=2022-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982539, encodeId=4d4d1982539ba, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, 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style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Mon May 17 13:59:00 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966190, encodeId=16c796619047, content=激素阳性的乳腺癌,采用CDK4/6联合内分泌治疗值得期待,希望价格患者可以承受, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210425/188bc6472a1742d09222864964fb4cca/508399781e704ed38acfdf86b724aef5.jpg, createdBy=d0e75483900, createdName=tjlyp, createdTime=Mon May 17 09:03:02 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038294, encodeId=627b103829431, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 16 01:59:00 CST 2021, time=2021-05-16, status=1, ipAttribution=)]
    2021-05-17 july_977
  9. [GetPortalCommentsPageByObjectIdResponse(id=1866090, encodeId=cd8818660909d, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Mar 08 04:59:00 CST 2022, time=2022-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982539, encodeId=4d4d1982539ba, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, 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style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Mon May 17 13:59:00 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966190, encodeId=16c796619047, content=激素阳性的乳腺癌,采用CDK4/6联合内分泌治疗值得期待,希望价格患者可以承受, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210425/188bc6472a1742d09222864964fb4cca/508399781e704ed38acfdf86b724aef5.jpg, createdBy=d0e75483900, createdName=tjlyp, createdTime=Mon May 17 09:03:02 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038294, encodeId=627b103829431, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 16 01:59:00 CST 2021, time=2021-05-16, status=1, ipAttribution=)]
    2021-05-17 tjlyp

    激素阳性的乳腺癌,采用CDK4/6联合内分泌治疗值得期待,希望价格患者可以承受

    0

  10. 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style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Mon May 17 13:59:00 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966190, encodeId=16c796619047, content=激素阳性的乳腺癌,采用CDK4/6联合内分泌治疗值得期待,希望价格患者可以承受, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210425/188bc6472a1742d09222864964fb4cca/508399781e704ed38acfdf86b724aef5.jpg, createdBy=d0e75483900, createdName=tjlyp, createdTime=Mon May 17 09:03:02 CST 2021, time=2021-05-17, status=1, ipAttribution=), 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    2021-05-16 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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近日,内分泌和代谢性疾病领域权威杂志Journal of Clinical Endocrinology & Metabolism上发表了一篇研究文章,这项研究旨评估热消融治疗原发性甲状旁腺功能

文献解读:含利多卡因的瑞蓝临床研究—医生与求美者的福音

越来越多的整形外科医生把目光聚集在非手术治疗的领域,虽说是非手术治疗,许多求美者因为惧怕注射带来的疼痛感而对注射类的美容治疗望而生畏。一项调研数据显示

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【热点解读】2024 DEGRO 乳腺癌脑转移和软脑膜癌病个体化放射治疗指南

本综述的目的是评估乳腺癌患者脑转移放疗的现有证据,并为脑转移和软脑膜癌病的放疗使用提供建议。

精准医疗时代下的乳腺癌基因检测

目前,临床可以借助基因检测等手段对乳腺癌进行亚型分型,进而选择最适合患者的治疗方案。

三阴性乳腺癌患者新辅助治疗后7个月内,结合病理评估和ctDNA检测可识别更高危亚组

研究者提出,通过结合组织反应和敏感的ctDNA检测,可以识别接受新辅助治疗方案的高危早期TNBC患者亚组。

邵志敏教授:聚力分型精准,引领诊疗变革——乳腺癌精准诊疗新模式

邵志敏教授团队提出的基于分型精准诊疗的新模式,以及其在临床实践中的应用和展望。

NEJM:瑞博西尼联合内分泌治疗对HR阳性、HER2阴性早期乳腺癌的无侵袭性疾病生存期的影响

该研究结果显示瑞博西尼联合内分泌治疗可显著改善HR阳性、HER2阴性II或III期早期乳腺癌患者的无侵袭性疾病生存期,较单独内分泌治疗组降低25.2%的风险,未发现新的安全信号。