Lancet Oncol:≥80岁的非转移性去势抵抗性前列腺癌患者是否可使用雄激素受体抑制剂治疗?

2021-07-29 Nebula MedSci原创

非转移性去势抵抗性前列腺癌老年患者可使用雄激素受体抑制剂治疗

对于非转移性去势抵抗性前列腺癌老年患者,二代雄激素受体抑制剂的获益-风险特征尚知之甚少。本研究旨在检查二代雄激素受体抑制剂对 80 岁或以上非转移性去势抵抗性前列腺癌患者的疗效和安全性。

Fallah等研究人员检索了2020年8月15日之前提交到US FDA的所有评估二代雄激素受体抑制剂用于非转移性去势抵抗性前列腺癌患者的随机对照临床试验,有3项试验符合纳入标准。这3项试验的受试者都是18 岁及以上的去势抵抗性前列腺癌患者(PSA≥2.0 ug/L)。在该研究中,研究人员评估了年龄对意向治疗人群中各年龄组(<80 岁 vs ≥80 岁)患者无转移生存率和总生存率的影响。

研究流程

2013年10月14日至2018年3月9日期间,3项随机试验共4117位患者被分至雄激素受体抑制剂组(阿帕鲁胺、恩杂鲁胺或达拉鲁胺;n=2694)或安慰剂组(n=1423)。无转移生存期的中位随访时间为 18 个月(IQR 11-26),总生存期的中位随访时间为 44 个月(32-55)。

生存预后

在≥80 岁的患者(n=1023)中,雄激素受体抑制剂组的估计中位无转移生存期为 40 个月,而安慰剂组的为 22 个月(校正风险比[HR] 0.37);两组的中位总生存期分别是54个月和49个月(校正HR 0.79)。

在<80 岁的患者 (n=3094) 中,雄激素受体抑制剂组的估计中位无转移生存期为 41 个月,而安慰剂组的为 16 个月(校正HR 0.31);两组的中位总生存期分别是74个月和61个月(校正HR 0.69)。

不良事件发生情况

在≥80 岁的患者中,雄激素受体抑制剂组和安慰剂组的3级及以上的不良事件的发生率分别是55%(371/672)和41%(140/344);在<80 岁的患者中,这两组的≥3级不良事件的发生率分别是44%(878/2015)和30%(321/1073)。最常见的3-4级不良事件是高血压和骨折。

综上,该汇总分析结果支持非转移性去势抵抗性前列腺癌老年患者使用雄激素受体抑制剂治疗

原始出处:

Jaleh Fallah, et al. Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials. The Lancet Oncology. July 23, 2021. https://doi.org/10.1016/S1470-2045(21)00334-X

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CST 2021, time=2021-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342170, encodeId=1fbc13421e03b, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37234, encryptionId=da143e23485, topicName=去势抵抗性前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Jul 31 14:16:31 CST 2021, time=2021-07-31, status=1, ipAttribution=)]
    2022-04-14 yige2012
  4. 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  5. 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channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99694, encryptionId=fc8c9969495, topicName=非转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, createdName=yinhl1978, createdTime=Sun Nov 28 06:16:31 CST 2021, time=2021-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1350588, encodeId=fa521350588e0, content=<a href='/topic/show?id=a7689869104' target=_blank style='color:#2F92EE;'>#雄激素受体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98691, encryptionId=a7689869104, topicName=雄激素受体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Jul 31 14:16:31 CST 2021, time=2021-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1459344, encodeId=3143145934455, content=<a 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CST 2021, time=2021-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342170, encodeId=1fbc13421e03b, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37234, encryptionId=da143e23485, topicName=去势抵抗性前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Jul 31 14:16:31 CST 2021, time=2021-07-31, status=1, ipAttribution=)]
    2022-02-02 howi
  6. 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CST 2021, time=2021-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342170, encodeId=1fbc13421e03b, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37234, encryptionId=da143e23485, topicName=去势抵抗性前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Jul 31 14:16:31 CST 2021, time=2021-07-31, status=1, ipAttribution=)]
  7. 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  8. [GetPortalCommentsPageByObjectIdResponse(id=1852721, encodeId=4f4b1852e211d, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Tue Mar 08 18:16:31 CST 2022, time=2022-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866175, encodeId=36e718661e586, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, 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  9. 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  10. 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