PRIME数据:PARP抑制剂一线维持治疗卵巢癌患者全人群获益

2022-04-23 网络 网络

2022 年第 53 届美国妇科肿瘤学会年会 (SGO) 于 2022 年 3 月 18 日至 21 日在美国以线上线下相结合的会议形式举行,分享有关妇科恶性肿瘤治疗的最新研究和实践创新,为患者提供最

2022 年第 53 届美国妇科肿瘤学会年会 (SGO) 于 2022 年 3 月 18 日至 21 日在美国以线上线下相结合的会议形式举行,分享有关妇科恶性肿瘤治疗的最新研究和实践创新,为患者提供最佳的诊疗方案。

本文梳理了2022年SGO会议报道的PRIME 研究:一项使用尼拉帕利个体化起始剂量维持治疗新诊断晚期卵巢癌疗效和安全性的随机,双盲,安慰剂对照,III期临床试验。(NCT03709316)

研究设计

PRIME研究将384名患者按2:1随机分组,接受尼拉帕利(n=255)或安慰剂(n=129)治疗36个月或直至疾病进展、死亡或出现不可耐受的毒性。

入组条件包括:患有FIGO III或IV期卵巢癌、高级别浆液性或子宫内膜样癌;既往接受过初始或间歇性减瘤术(无论术后肿瘤残留状态);对一线铂类化疗完全缓解(CR)或部分缓解(PR)。

分层因素:包括gBRCA突变状态、肿瘤HRD状态、既往接受新辅助化疗、一线铂类化疗的响应。

主要终点:在ITT人群中通过独立盲法中心评估(BICR)的PFS。次要终点:IIT人群总生存(OS)和首次后续抗癌治疗的时间(TFST);HRD亚组中的PFS和OS;安全性。

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在数据截止时,尼拉帕利组的102名患者和安慰剂组的29名患者仍在接受治疗。中位随访时间为27.5个月。

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主要基线特征:尼拉帕利组和安慰剂组FIGO III 期患者分别有 71.4% 和 72.9%;尼拉帕利组和安慰剂组对既往含铂化疗达到 CR的患者分别为 83.1% 和 79.8%;尼拉帕利组和安慰剂组gBRCA 突变患者分别为33.3% 和 31.0%。

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主要终点:在BICR评估的ITT人群中,与安慰剂组相比,尼拉帕利维持治疗显著延长患者PFS(24.8个月vs 8.3个月)(HR=0.45,95%CI:0.34~0.60,P<0.001)。

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根据PRIME研究预设的亚组分析:无论gBRCA突变状态,尼拉帕利均延长患者PFS

在gBRCA突变患者中,中位PFS尚未达到(95%CI,22.3-NE),而安慰剂组10.8个月(95%CI,8.3-19.3)(HR=0.40,95%CI:0.23~0.68,P<0.001)。

在非gBRCA突变患者中,中位PFS 19.3个月(95%CI: 13.8-NE),对比安慰剂组8.3个月(95%CI: 5.6-11.2)(HR=0.48,95%CI:0.34~0.67,P<0.001)。

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非gBRCA突变组:无论HRD状态均观察到尼拉帕利PFS获益

非gBRCA突变/HRd患者中,中位PFS 24.8个月(95%CI: 14.0-NE)对比安慰剂组11.1个月(95%CI: 8.3-13.8)(HR=0.58,95%CI:0.36~0.93,P=0.022);

非gBRCA突变/HRp患者中,中位PFS 14.0个月(95%CI: 11.9-NE)对比安慰剂组5.5个月(95%CI: 2.9-7.3)(HR=0.41,95%CI:0.25~0.65,P<0.001)。

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次要终点:在HRD亚组的PFS

尼拉帕利组的中位PFS未达到(NR; 95%CI: 22.3-NE),而安慰剂组为11.0个月(95%CI: 8.3-13.8)(HR=0.48;95%CI: 0.34-0.68;P<0.001)。

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次要终点OS和TFST

OS数据尚未成熟,但在数据截止时,尼拉帕利组显示出更优的趋势。(HR=0.63;95%CI: 0.38-1.03;P=0.061)。

在尼拉帕利组,至首次后续抗癌治疗中位时间(mTFST)为29.2个月(95%CI: 22.4–NE),安慰剂组为11.9个月(95%CI: 8.8-14.8)。

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安全性

PRIME研究采用个体化给药剂量,与既往PRIMA研究相比,尼拉帕利组的治疗终止率进一步降低。尼拉帕组的治疗终止率为仅为6.7%,与安慰剂相似5.4%。

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尼拉帕利和安慰剂组超过20%的患者中观察到≥3级TEAE,包括中性粒细胞计数降低(17.3%vs 1.6%)、白细胞计数降低(6.7% vs 0.8%)、贫血(18.0% vs 1.6%)、血小板计数减少(14.1% vs 0.8%)和谷氨酰转移酶增加(5.1% vs 17.1%)。

结论

a)  PRIME研究前瞻性的表明,无论生物标记物状态和术后残余病灶状态如何,与安慰剂相比,尼拉帕利个体化起始剂量作为新诊断晚期卵巢癌一线维持治疗,具有统计学意义和临床意义的PFS获益。 

b) 所有患者均前瞻性采用个体化起始剂量,尼拉帕利的安全性得到改善。

c)  PRIME数据再次验证:无论生物标记物状态如何,尼拉帕利单药维持是一线含铂化疗后的标准治疗。

参考文献:

1. Li N, Zhu J, Yin R, et al. Efficacy and safety of niraparib as maintenance treatment in patients with newly diagnosed advanced ovarian cancer using an individualized starting dose (PRIME Study): a randomized, double-blind, placebo-controlled, phase 3 trial.Presented at: 2022 SGO Annual Meeting on Women’s Cancer; March 18-21, 2022. Phoenix,Arizona

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    2022-08-22 jklm09
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    2022-04-25 lishiwen
  5. [GetPortalCommentsPageByObjectIdResponse(id=1734769, encodeId=0a0b1e34769ab, content=<a href='/topic/show?id=779319429d6' target=_blank style='color:#2F92EE;'>#一线维持治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19429, encryptionId=779319429d6, topicName=一线维持治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a96233820512, createdName=venlin, createdTime=Mon Mar 20 14:52:17 CST 2023, time=2023-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852950, encodeId=f02318529505a, 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=33, 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=Mon Aug 22 20:52:17 CST 2022, time=2022-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1222006, encodeId=5a3b12220066f, content=<a href='/topic/show?id=e08113e613e' target=_blank style='color:#2F92EE;'>#PARP抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13761, encryptionId=e08113e613e, topicName=PARP抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=清风徐来2022, createdTime=Tue May 24 11:17:57 CST 2022, time=2022-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621397, encodeId=11cd162139e52, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 25 02:52:17 CST 2022, time=2022-04-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1213675, encodeId=f1cf12136e530, content=好文章,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Sat Apr 23 15:05:10 CST 2022, time=2022-04-23, status=1, ipAttribution=)]
    2022-04-23 yangchou

    好文章,谢谢分享。

    0

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