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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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style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, 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=83, 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=68, 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=54, 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=55, 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=56, 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=83, 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=68, 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=54, 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=55, 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=56, 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=83, 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=68, 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=56, 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=83, 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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5年生存率近87%!NEJM:治疗“最毒”乳腺癌,新辅助免疫联合方案最终数据揭晓

在早期三阴性乳腺癌患者的新辅助治疗中,在化疗基础上联用帕博利珠单抗可显著改善总生存期,5年生存率从81.7%提升至86.6%,提高近5%,且长期持续带来无事件生存期获益。

【协和医学杂志】PTEN基因突变Cowden综合征相关单侧多中心乳腺癌及同时性、异时性双侧乳腺癌3例

HTS/Cowden综合征是多系统受累的罕见疾病,会导致乳腺癌等多种肿瘤患病风险增加,对于此类患者,早诊早治至关重要。

乳腺癌脑转移预测模型

乳腺癌脑转移预测模型

62%乳腺癌脑转移患者,12个月病情未进展!重磅ADC治疗再添新证| ESMO 2024

T-Dxd在HER2阳性转移性乳腺癌患者中表现出显著且持久的整体和颅内活性,未发现新的安全性信号。

Nat Med:重磅ADC积极结果,超半数HER2阳性脑转移患者一年内无疾病进展

研究结果表明,Enhertu在HER2阳性晚期乳腺癌患者中显示出显著且持久的总体和颅内活性,支持将其用于先前接受过治疗的HER2阳性晚期乳腺癌患者,无论其基线脑转移是稳定还是活跃。

不用化疗,近50%患者癌细胞完全消失!“双免疫”疗法为“最毒乳腺癌”治疗带来新方向 | ESMO 2024

ESMO 年会报道三阴性乳腺癌高水平 TILs 患者双免治疗探索性试验,两种方案 pCR 率分别为 33% 和 47%,需进一步了解无化疗免疫治疗效果及毒性。

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