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阿替利珠单抗联合贝伐珠单抗对比舒尼替尼用于治疗未经治疗的伴肉瘤样特征的转移性肾细胞癌患者:IMmotion151 临床试验的预先设定亚组分析。

Atezolizumab plus Bevacizumab Versus Sunitinib for Patients with Untreated Metastatic Renal Cell Carcinoma and Sarcomatoid Features: A Prespecified Subgroup Analysis of the IMmotion151 Clinical Trial.

机构信息

Vanderbilt University Medical Center, Nashville, TN, USA.

Memorial Sloan Kettering Cancer Center, New York, NY, USA.

出版信息

Eur Urol. 2021 May;79(5):659-662. doi: 10.1016/j.eururo.2020.06.021. Epub 2020 Jul 9.

Abstract

Patients with metastatic renal cell carcinoma with sarcomatoid features (sRCC) have a poor prognosis and have shown limited responsiveness to inhibition of the VEGF pathway. We conducted a prespecified analysis of the randomised, phase 3 IMmotion151 trial in previously untreated patients with advanced or metastatic RCC to assess the effectiveness of atezolizumab + bevacizumab versus sunitinib in a subgroup of patients with sarcomatoid features. Patients whose tumour had any component of sarcomatoid features were included and received atezolizumab + bevacizumab (n = 68) or sunitinib (n = 74). Baseline characteristics were similar between the groups. Median progression-free survival was significantly longer in the group receiving atezolizumab + bevacizumab overall (8.3 vs 5.3 mo; hazard ratio [HR] 0.52 95% confidence interval [CI] 0.34-0.79) and in the subset of patients with PD-L1-positive tumours (8.6 vs 5.6 mo; HR 0.45, 95% CI 0.26-0.77). More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib. Safety was consistent with the known profiles of each drug and with that reported in the overall safety-evaluable population of IMmotion151. This analysis supports enhanced activity of atezolizumab + bevacizumab in patients with sRCC. PATIENT SUMMARY: In this report, we looked at patients with a specific type of kidney cancer (tumours with sarcomatoid features) that has been hard to treat. A treatment with two drugs (atezolizumab and bevacizumab) appeared to help patients live longer without the disease getting worse than another drug (sunitinib) that is often used. Patients who took the two drugs also said they were better able to carry out their everyday activities than patients who took sunitinib. The combination of these two drugs may work better in patients with this type of advanced kidney cancer.

摘要

患者患有转移性肾细胞癌伴肉瘤样特征(sRCC),预后较差,对 VEGF 通路抑制的反应有限。我们对先前未经治疗的晚期或转移性 RCC 患者进行了随机、III 期 IMmotion151 试验的预设分析,以评估阿替利珠单抗+贝伐珠单抗与舒尼替尼在肉瘤样特征患者亚组中的疗效。纳入了肿瘤有任何肉瘤样特征成分的患者,并接受阿替利珠单抗+贝伐珠单抗(n=68)或舒尼替尼(n=74)治疗。两组患者的基线特征相似。总体而言,接受阿替利珠单抗+贝伐珠单抗治疗的患者中位无进展生存期明显更长(8.3 与 5.3 个月;风险比[HR]0.52,95%置信区间[CI]0.34-0.79),且 PD-L1 阳性肿瘤患者亚组中也是如此(8.6 与 5.6 个月;HR 0.45,95%CI 0.26-0.77)。接受阿替利珠单抗+贝伐珠单抗治疗的患者更多地获得了客观缓解(49%比 14%),包括完全缓解(10%比 3%),并报告了比舒尼替尼更大的症状改善。安全性与每种药物的已知特征以及 IMmotion151 的总体可评估安全性人群中的报告一致。这项分析支持在 sRCC 患者中使用阿替利珠单抗+贝伐珠单抗的疗效增强。

患者总结

在本报告中,我们研究了一种特定类型的肾癌(具有肉瘤样特征的肿瘤)患者,这种肿瘤很难治疗。一种包含两种药物(阿替利珠单抗和贝伐珠单抗)的治疗方法似乎能帮助患者延长生存期,而不会使病情恶化,而另一种常用药物(舒尼替尼)则会使病情恶化。与服用舒尼替尼的患者相比,服用这两种药物的患者表示,他们能够更好地进行日常活动。这两种药物的联合使用可能对这种类型的晚期肾癌患者更有效。

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