ASCO GU 2021: Nivolumab联合Cabozantinib与舒尼替尼在晚期肾细胞癌中效果对比(CheckMate 9ER研究)

2021-02-16 MedSci原创 MedSci原创

在过去的两年中,转移性肾细胞癌(mRCC)患者一线治疗的治疗方式发生了巨大变化。 2018年,CheckMate214数据的发布表明,在中度和低风险的mRCC中,与舒尼替尼相比,用nivolumab和

在过去的两年中,转移性肾细胞癌(mRCC)患者一线治疗的治疗方式发生了巨大变化。 2018年,CheckMate214数据的发布表明,在中度和低风险的mRCC中,与舒尼替尼相比,用nivolumab和ipilimumab治疗的患者具有生存优势,从而开启了mRCC的免疫治疗时代。随后在2019年发表的JAVELIN Renal 101和KEYNOTE-426研究证明,相比于舒尼替尼在这种疾病领域中,avelumab和axitinib以及pembrolizumab和axitinib的优越性。这两项试验首次证明,与先前的护理标准舒尼替尼相比,将免疫疗法与检查点抑制和靶向疗法相结合可提高总体生存率。这些数据发布后的网络荟萃分析证明了这种组合方法的明显优势。

在ESMO 2020上,Choueiri博士展示了与舒尼替尼相比,将nivolumab和Cabozantinib组合使用CheckMate-9ER的第一结果,用于一线治疗晚期或转移性肾细胞癌患者。这份尚未发表的第一份报告显示,在无进展生存期和总生存期方面,在晚期肾细胞癌患者的一线治疗中,尼古鲁单抗+卡博替尼比苏尼替尼具有优越性,并得到了批准。在2021年ASCO GU癌症专题研讨会的海报重点会议:肾细胞癌-临床试验更新会议上的全体会议摘要中,Robert Motzer博士介绍了CheckMate-9ER的最新结果,该结果评估了益处的持久性以及评估结果肉瘤样特征的患者,一种侵袭性的组织学亚型,预后不良。

CheckMate-9ER是一项全球多中心、开放标签、随机对照的Ⅲ期临床试验,纳入先前未经治疗的晚期或转移性肾透明细胞癌患者,按1∶1比例随机分配,分别接受纳武利尤单抗(240mg,Q2W)联合卡博替尼(40mg,QD)治疗或舒尼替尼(50mg,QD,服药4周后休息2周)治疗,直至疾病进展或不可接受的毒性。研究的主要终点为盲化独立评审委员会(BICR)评估的PFS,次要终点包括OS、ORR和安全性等。此外,通过局部病理学报告可确定有无肉瘤样RCC的患者,并通过预先指定的子集分析评估这些患者的结局。

 



ASCO_GU_CheckMate214.png

在ITT人群中的651例患者中,有75例(11.5%)被发现有肉瘤样组织学,557例(84.6%)没有被发现,19例(2.9%)没有被发现。

微信截图_20200920014320 - 副本.png

在这75名患者中,有34名被随机分配给nivolumab和卡博替尼,有41名被随机分配给舒尼替尼。 与截至2020年3月30日的具有数据库锁定的主要分析相反,本分析提供截至2020年9月10日的数据库锁定为18.1个月的更新结果。

利用这些更新的数据,作者证明了无进展生存(危险比0.52,95%置信区间0.43-0.64)和总体生存(危险比0.66,95%置信区间0.50-0.87)的持续显着改善。

ASCO_GU_ITT_population.png

在具有肉瘤样组织学的患者中,与舒尼替尼相比,接受nivolumab和Cabozantinib治疗的患者的无进展生存期,总体生存率和客观缓解率均有显着改善。 此外,与舒尼替尼相比,具有肉瘤样组织学的患者相比没有肉瘤样组织学的患者,其相对获益更大。

ASCO_GU_sarcomatoid_histology.png

因此,作者得出的结论是,与舒尼替尼相比,无论是否存在肉瘤样组织学,Nivolumab和卡博替尼联合均具有更高的疗效和生存结果。

另外,本次会议上还报道了的CheckMate 9ER的患者报告结局(PRO)结果。

ASCOGU21_checkmate9er-Cella_2.png

进行数据分析时,总体生存期的中位随访时间为18.1个月。 基线时,超过90%的患者完成了患者报告的结局指标,在第91周之前的所有治疗评估中,至少80%的患者均完成了评估。 用FKSI-19(所有域)和EQ-5D-3L测得,与接受舒尼替尼治疗的患者相比,用尼古鲁单抗和卡博替尼治疗的基线偏爱患者的总体最小二乘方差的平均差异。

ASCOGU21_checkmate9er-Cella_3.png

与舒尼替尼相比,接受Nivolumab和卡博替尼治疗的患者的治疗负担更轻,并且在大多数测量中确诊恶化的风险降低,包括FKSI-19总体症状,疾病相关症状(DRS),DRS身体症状(DRS-P),DRS情绪激动 (DRS-E),功能性健康(FWB)和EQ-5D-3L视觉模拟量表(VAS)得分。

ASCOGU21_checkmate9er-Cella_4.png

作者得出的结论是,除了先前提供的数据显示出无进展生存期和总体生存期方面的优越性之外,与舒尼替尼治疗的患者相比,接受nivolumab和Cabozantinib治疗的患者具有统计学上显着的HRQoL益处。

原始出处:

ASCO GU 2021: Nivolumab + Cabozantinib Versus Sunitinib for Advanced Renal Cell Carcinoma (aRCC): Outcomes by Sarcomatoid Histology and Updated Trial Results with Extended Follow-up of CheckMate 9ER

ASCO GU 2021: Patient-Reported Outcomes Of Patients With Advanced Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Cabozantinib Versus Sunitinib: The Checkmate 9ER Trial

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    2021-08-28 tamgche
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    2021-11-01 snf701207
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    2021-12-02 quxin068
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    2021-02-18 闆锋旦
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    2021-02-16 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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透明细胞肾细胞癌(ccRCC)本质上是一种代谢紊乱,其特点是几种代谢途径的重新编程。酰基辅酶A硫酯酶(ACOTs)是参与脂肪酸代谢的关键酶,然而,ACOTs在ccRCC中的作用仍不清楚。最近,有研究人

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2018年纳武利尤单抗+伊匹单抗获FDA批准用于晚期肾细胞癌患者的一线治疗;2019年,美国FDA批准帕博利珠单抗联合阿昔替尼(axitinib)可用于晚期肾细胞癌(RCC)患者的一线治疗。