BACKGROUND Cabozantinib improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with everolimus in patients with advanced renal cell carcinoma (RCC) after prior antiangiogenic therapy in the phase III METEOR trial (NCT01865747). Limited data are available on the use of targeted therapies in older patients with advanced RCC. METHODS Efficacy and safety in METEOR were retrospectively analysed for three age subgroups: <65 (n = 394), 65-74 (n = 201) and ≥75 years (n = 63). RESULTS PFS, OS and ORR were improved with cabozantinib compared with everolimus in all age subgroups. The PFS hazard ratios (HRs) were 0.53 (95% confidence interval [CI]: 0.41-0.68), 0.53 (95% CI: 0.37-0.77) and 0.38 (95% CI: 0.18-0.79) for <65, 65-74 and ≥75 years, respectively, and the OS HRs were 0.72 (95% CI: 0.54-0.95), 0.66 (95% CI: 0.44-0.99) and 0.57 (95% CI: 0.28-1.14). The ORR for cabozantinib versus everolimus was 15% vs 5%, 21% vs 2% and 19% vs 0%, respectively. No significant differences were observed in PFS or OS with age as a categorical or continuous variable. Grade III/IV adverse events (AEs) were generally consistent across subgroups, although fatigue, hypertension and hyponatraemia occurred more frequently in older patients treated with cabozantinib. Dose reductions to manage AEs were more frequent in patients receiving cabozantinib than in those receiving everolimus. Dose reductions and treatment discontinuation due to AEs were more frequent in older patients in both treatment groups. CONCLUSIONS Cabozantinib improved PFS, OS and ORR compared with everolimus in previously treated patients with advanced RCC, irrespective of age group, supporting use in all age categories. Proactive dose modification and supportive care may help to mitigate AEs in older patients while maintaining efficacy.

中文翻译：

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卡博替尼与依维莫司在晚期肾细胞癌患者的III期METEOR试验中基于年龄的结果。

背景在III期METEOR试验（NCT01865747）中，经过事先抗血管生成治疗的晚期肾细胞癌（RCC）患者，卡波替尼与依维莫司相比，改善了无进展生存期（PFS），总生存期（OS）和客观反应率（ORR）。关于晚期RCC老年患者使用靶向疗法的数据有限。方法回顾性分析了三个年龄组的流星的疗效和安全性：<65岁（n = 394），65-74岁（n = 201）和≥75岁（n = 63）。结果与所有年龄亚组的依维莫司相比，卡波替尼的PFS，OS和ORR均有改善。对于<65、65-分别为74岁和≥75岁，OS HRs为0.72（95％CI：0.54-0.95），0.66（95％CI：0.44-0.99）和0.57（95％CI：0.28-1.14）。卡波替尼与依维莫司的ORR分别为15％对5％，21％对2％和19％对0％。在PFS或OS中，年龄作为分类变量或连续变量没有观察到显着差异。尽管疲劳，高血压和低血钠血症在接受卡博替尼治疗的老年患者中更常见，但各亚组的III / IV级不良事件（AE）总体上是一致的。与接受依维莫司治疗的患者相比，接受卡博替尼治疗的患者减少AE的剂量更为频繁。在两个治疗组中，老年患者中因AE引起的剂量减少和治疗中止更为频繁。结论与依维莫司相比，卡波替尼在既往接受过治疗的晚期RCC患者中改善了PFS，OS和ORR，与年龄组无关，支持所有年龄段的使用。主动调整剂量和支持治疗可能有助于减轻老年患者的AE，同时保持疗效。