肉瘤样肾细胞癌（sRCC）患者预后较差。在随机、双盲 3 期 IMmotion010 试验 (NCT03024996) 中，在手术后复发风险增加的局部区域肾细胞癌患者总体人群中，与安慰剂相比，辅助 atezolizumab 并未表现出无病生存 (DFS) 获益。这项预先指定的疗效和安全性亚组分析是在 104 名 sRCC 患者中完成的。治疗组之间的基线特征相似。在中位随访 45 个月时，阿替利珠单抗组 (n = 37) 和 23 个月 (95% CI, 11) 的中位 DFS 不可评估（NE；95% 置信区间 [CI]，12 个月-NE） -NE）在安慰剂组中（n = 66；风险比 0.77 [95% CI，0.44-1.4]）。在 sRCC 亚组中，atezolizumab 组的 1 名患者 (2.7%) 和安慰剂组的 2 名患者 (3.0%) 发生了 3/4 级治疗相关不良事件 (TRAE)。相比之下，353 名非肉瘤样组织学患者中的 54 名 (15%) 和 317 名患者中的 16 名 (5.0%) 报告各自手臂中发生了 3/4 级 TRAE。总之，对于 sRCC 患者，辅助 atezolizumab 和安慰剂之间的 DFS 差异不具有统计学意义。 sRCC 和非 sRCC 患者的安全性相似。患者摘要：患有特定类型局部肾癌（具有肉瘤样特征的肿瘤）的患者在手术后接受阿替利珠单抗或安慰剂治疗。与接受安慰剂治疗的患者相比，接受 atezolizumab 治疗的患者在病情没有恶化的情况下寿命更长，但这一发现并不具有统计学意义。副作用与同一研究 (IMmotion010) 中使用 atezolizumab 治疗的其他类型肾癌患者中观察到的副作用相似。在肉瘤样肾癌患者中，atezolizumab 是可耐受的，并且可能比安慰剂更有效，但这需要进一步研究。版权所有 © 2024。由 Elsevier B.V 出版。

Patients with sarcomatoid renal cell carcinoma (sRCC) have a poor prognosis. In the randomised, double-blind phase 3 IMmotion010 trial (NCT03024996), adjuvant atezolizumab did not demonstrate a disease-free survival (DFS) benefit versus placebo in the overall population of patients with locoregional renal cell carcinoma with an increased risk of recurrence following surgery. This prespecified subgroup analysis of efficacy and safety was completed in 104 patients with sRCC. Baseline characteristics were similar between treatment arms. At a median follow-up of 45 mo, the median DFS was not evaluable (NE; 95% confidence interval [CI], 12 mo-NE) in the atezolizumab arm (n = 37) and 23 mo (95% CI, 11-NE) in the placebo arm (n = 66; hazard ratio 0.77 [95% CI, 0.44-1.4]). In the sRCC subgroup, grade 3/4 treatment-related adverse events (TRAEs) occurred in one patient (2.7%) in the atezolizumab arm and two patients (3.0%) in the placebo arm. By comparison, 54 of 353 patients (15%) and 16 of 317 patients (5.0%) with non-sarcomatoid histology reported grade 3/4 TRAEs in the respective arms. In conclusion, the difference in DFS was not statistically significant between adjuvant atezolizumab and placebo in patients with sRCC. The safety profile was similar between patients with sRCC and non-sRCC. PATIENT SUMMARY: Patients with a specific type of locoregional kidney cancer (tumours with sarcomatoid features) were treated with atezolizumab or placebo after surgery. Slightly more patients treated with atezolizumab lived longer without the disease getting worse than those treated with placebo, although this finding was not statistically significant. The side effects were similar to those seen in patients with other types of kidney cancer treated with atezolizumab in the same study (IMmotion010). In patients with sarcomatoid kidney cancer, atezolizumab was tolerable and may be more effective than placebo, but this requires further study.Copyright © 2024. Published by Elsevier B.V.