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ASCO GU 2021:ERLEADA联合ZYTIGA治疗转移性去势抵抗性前列腺癌III期临床

2021-02-09 Allan MedSci原创

与对照组相比,联合组患者的中位rPFS延长了6个月(22.6 vs. 16.6个月,危险比 0.69,95%CI 0.58-0.83,p<0.0001)。

强生制药公司今天公布了一项随机、双盲、安慰剂对照的III期临床(ACIS研究)的结果,该研究达到了放射学无进展生存期(rPFS)的主要终点,将初治转移性去势抵抗性前列腺癌(mCRPC)患者的死亡风险降低了31%。该试验的患者接受了ERLEADA®/ZYTIGA®/泼尼松(联合用药组)的治疗,或安慰剂/ZYTIGA®/泼尼松(对照组)的治疗。结果将在美国临床肿瘤学会泌尿学会(ASCO GU)研讨会上公布。

初步疗效分析显示,与对照组相比,联合组患者的中位rPFS延长了6个月(22.6 vs. 16.6个月,危险比 0.69,95%CI 0.58-0.83,p<0.0001)。根据中位随访54.8个月的最新分析,与对照组相比,联合组的影像学进展或死亡风险降低了30%。对于次要终点,包括总生存期(OS)、开始细胞毒性化疗的时间等,两组没有统计学上的显著差异。

纪念斯隆·凯特琳癌症中心的Dana Rathkopf博士说:“ACIS研究的数据表明,在评估ERLEADA联合ZYTIGA联合泼尼松治疗转移性去势抵抗性前列腺癌的治疗中,rPFS的显著提高”。

 

原始出处:

https://www.firstwordpharma.com/node/1798228?tsid=28&region_id=5

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    2021-04-19 quxin068
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    2021-10-01 juliusluan78
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createdName=yige2012, createdTime=Mon Nov 01 09:08:54 CST 2021, time=2021-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916404, encodeId=0c2f1916404c6, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Oct 01 21:08:54 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653159, encodeId=4d0616531591f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri May 14 08:08:54 CST 2021, time=2021-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264765, encodeId=9ea91264e65bb, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342157, encodeId=6823134215e5e, 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=71, 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=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353199, encodeId=efd0135319937, content=<a href='/topic/show?id=a872695382' target=_blank style='color:#2F92EE;'>#Erleada#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6953, encryptionId=a872695382, topicName=Erleada)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386708, encodeId=49631386e08a5, 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=86, 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=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466232, encodeId=f66f146623252, content=<a href='/topic/show?id=56fb19113a3' target=_blank style='color:#2F92EE;'>#Zytiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19113, encryptionId=56fb19113a3, topicName=Zytiga)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82186780852, createdName=lqrandywkz, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503962, encodeId=3ab615039625f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1939132, encodeId=eabd19391324c, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Apr 19 22:08:54 CST 2021, time=2021-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666068, encodeId=a1fa166606896, content=<a href='/topic/show?id=6f7d553159c' target=_blank style='color:#2F92EE;'>#抗性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55315, encryptionId=6f7d553159c, topicName=抗性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d5926034382, createdName=yige2012, createdTime=Mon Nov 01 09:08:54 CST 2021, time=2021-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916404, encodeId=0c2f1916404c6, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Oct 01 21:08:54 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653159, encodeId=4d0616531591f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri May 14 08:08:54 CST 2021, time=2021-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264765, encodeId=9ea91264e65bb, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342157, encodeId=6823134215e5e, 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, 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CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386708, encodeId=49631386e08a5, 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=86, 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=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466232, encodeId=f66f146623252, content=<a href='/topic/show?id=56fb19113a3' target=_blank style='color:#2F92EE;'>#Zytiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19113, encryptionId=56fb19113a3, topicName=Zytiga)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82186780852, createdName=lqrandywkz, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503962, encodeId=3ab615039625f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
    2021-02-11 柳叶一刀
  6. [GetPortalCommentsPageByObjectIdResponse(id=1939132, encodeId=eabd19391324c, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Apr 19 22:08:54 CST 2021, time=2021-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666068, encodeId=a1fa166606896, content=<a href='/topic/show?id=6f7d553159c' target=_blank style='color:#2F92EE;'>#抗性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55315, encryptionId=6f7d553159c, topicName=抗性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d5926034382, 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  7. 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CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386708, encodeId=49631386e08a5, 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=86, 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=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466232, encodeId=f66f146623252, content=<a href='/topic/show?id=56fb19113a3' target=_blank style='color:#2F92EE;'>#Zytiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19113, encryptionId=56fb19113a3, topicName=Zytiga)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82186780852, createdName=lqrandywkz, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503962, encodeId=3ab615039625f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
    2021-02-11 zhaojie88
  8. 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  9. 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    2021-02-11 lqrandywkz
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Janssen-Cilag International NV(Janssen)宣布,欧盟委员会(EC)已批准扩大Zytiga(醋酸阿比特龙)联合泼尼松/泼尼松龙的现有上市许可,目前的适应症扩大到早期转移性前列腺癌。醋酸阿比特龙联合泼尼松/泼尼松龙现在可以联合雄激素剥夺疗法(ADT)治疗成年男性新诊断的高危转移性激素敏感性前列腺癌(mHSPC)。"前列腺癌是整个欧洲男性最常见的癌症形式,该决定有助于

杨森前列腺癌新药获FDA扩大适应症批准

强生集团旗下杨森(Janssen)公司近日宣布,FDA已批准了ZYTIGA(醋酸阿比特龙)联合泼尼松(prednisone)治疗转移高危性去势敏感型前列腺癌(CSPC)患者。该批准基于关键3期临床试验LATITUDE的数据。研究发现,在转移高危性CSPC患者中与安慰剂相比,ZYTIGA联合泼尼松将死亡风险降低了38%。

Onvansertib能够克服Zytiga耐药性并为mCRPC患者提供临床益处

Trovagene是一家临床阶段的肿瘤治疗公司,其研究性新药Onvansertib预期用于治疗包括前列腺癌、结肠直肠癌和白血病在内的多种癌症,该公司近日宣布,正在进行的Onvansertib与Zytiga联合治疗转移性去势抵抗性前列腺癌(mCRPC)的II期试验取得了积极结果。

Trovagene在ASCO-GU会议上介绍了Onvansertib与Zytiga联合治疗mCRPC的II期研究

Trovagene是一家临床阶段肿瘤治疗公司,采用精准医学方法开发白血病、淋巴瘤和实体瘤癌症的治疗药物,Trovagene近日在加利福尼亚州旧金山的Genitourinary Cancer Symposium(ASCO-GU)会议上公布了正在进行的第II阶段研究,该研究评估了Onvansertib与Zytiga(醋酸阿比特龙)联合治疗转移性去势抵抗性前列腺癌(mCRPC)患者的安全性和耐受性。

重磅!强生Zytiga霸主地位不保,安斯泰来前列腺癌药物Xtandi拿下欧美2大市场

安斯泰来(Astellas)和Medivation合作研发的新一代前列腺癌口服药物Xtandi(enzalutamide)监管方面爆出大好消息。继今年9月FDA批准Xtandi用于前列腺癌化疗前治疗,近日欧盟也已批准Xtandi用于化疗前治疗。尽管强生(JNJ)新一代前列腺癌口服药物Zytiga早在2011年4月上市之后一直统治市场,但Xtandi具有单独用药的独特优势,业界预测,在欧美2大主要市

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World J Urol:转移部位和负担对转移性去势抵抗性前列腺癌患者肿瘤预后的影响

研究结果表明,内脏转移的mCRPC患者病情恶化和死亡的风险较高,而仅有淋巴结转移的患者的癌症控制效果最好。

World J Urol:恩杂鲁胺与醋酸阿比特龙治疗转移性去势抵抗性前列腺癌患者新发或恶化的2型糖尿病情况比较

与接受ENZA治疗的患者相比,接受AA治疗的mCRPC患者更有可能出现新发或恶化的T2DM,尽管治疗持续时间较短。

Eur Urol:转移性去势抵抗性前列腺癌和BRCA1/2基因改变的患者结果报告:随机3期 MAGNITUDE 试验的最终分析

大多数BRCA+ mCRPC患者在接受尼拉帕尼+AAP治疗后都能保持 HRQoL,且副作用极小。

Eur Urol:[177Lu]Lu-PSMA-617治疗的转移性去势抵抗性前列腺癌患者前列腺特异性抗原水平下降与临床结果的关系

美国研究人员发现,接受177Lu-PSMA-617加SoC治疗的mCRPC患者的PSA下降幅度与临床和患者报告结果的改善相关。

CLIN CANCER RES | BRCAAway 试验:阿比特龙/泼尼松+奥拉帕利联合治疗方案显著改善转移性去势抵抗性前列腺癌携带 HRRm 患者的预后

RCAAway 试验的结果表明,对于携带 BRCA1/2 或 ATM 突变的转移性去势抵抗性前列腺癌患者,一线治疗中阿比特龙/泼尼松+奥拉帕利联合治疗方案能够显著延长患者的PFS和OS且安全性良好。

Eur Urol Oncol:帕博利珠单抗联合醋酸阿比特龙和泼尼松治疗未经化疗的转移性去势抵抗性前列腺癌患者效果如何?

九国科学家联合研究评估了帕博利珠单抗联合阿比特龙治疗mCRPC的疗效和安全性。结果表明,在未经化疗的mCRPC患者中,帕博利珠单抗联合阿比特龙和泼尼松具有抗肿瘤活性和可接受的安全性。

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