Department of Urology, Niigata University Graduate School of Medicine, Niigata, Japan; Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan.
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
ESMO Open. 2022 Apr;7(2):100450. doi: 10.1016/j.esmoop.2022.100450. Epub 2022 Apr 6.
In the phase III JAVELIN Renal 101 trial, first-line avelumab plus axitinib demonstrated a progression-free survival (PFS) and objective response rate (ORR) benefit versus sunitinib in patients with advanced renal cell carcinoma (aRCC). However, efficacy in elderly patients remains unclear. We report efficacy and safety by age group from the second interim analysis of overall survival (OS).
PFS and ORR as per blinded independent central review (RECIST 1.1), OS, and safety were assessed in patient groups aged <65, ≥65 to <75, and ≥75 years.
In the avelumab plus axitinib and sunitinib arms, 271/138/33 and 275/128/41 patients aged <65, ≥65 to <75, and ≥75 years, respectively, were randomized. At data cut-off (January 2019), median PFS [95% confidence interval (CI)] with avelumab plus axitinib versus sunitinib in these respective age groups was 11.6 (8.4-19.4) versus 6.9 (5.6-8.4) months [hazard ratio (HR), 0.63; 95% CI 0.501-0.786], 13.8 (11.1-18.0) versus 11.0 (7.8-16.6) months (HR, 0.88; 95% CI 0.627-1.231), and 13.8 [7.0-not estimable (NE)] versus 9.8 (4.3-NE) months (HR, 0.76; 95% CI 0.378-1.511). Median OS (95% CI) in the respective age groups was not reached (NR) (NE-NE) versus 28.6 (25.5-NE) months (HR, 0.74; 95% CI 0.541-1.022), 30.0 (30.0-NE) versus NR (NE-NE) months (HR, 0.89; 95% CI 0.546-1.467), and 25.3 (19.9-NE) versus NR (19.4-NE) months (HR, 0.87; 95% CI 0.359-2.106). ORR (95% CI) in the respective age groups was 49.4% (43.3% to 55.6%) versus 27.3% (22.1% to 32.9%), 60.9% (52.2% to 69.1%) versus 28.9% (21.2% to 37.6%), and 42.4% (25.5% to 60.8%) versus 22.0% (10.6% to 37.6%). In the avelumab plus axitinib arm, grade ≥3 adverse events (AEs) and immune-related AEs occurred in 76.9%/81.2%/72.7% and 45.5%/48.1%/36.4% in the respective age groups.
First-line avelumab plus axitinib demonstrated favorable efficacy across age groups, including patients aged ≥75 years. OS data were still immature; follow-up is ongoing. The safety profile was generally consistent across age groups.
在 III 期 JAVELIN Renal 101 试验中，一线阿维鲁单抗联合阿昔替尼在晚期肾细胞癌（aRCC）患者中与舒尼替尼相比，在无进展生存期（PFS）和客观缓解率（ORR）方面显示出获益。然而，老年患者的疗效仍不清楚。我们报告了总生存期（OS）第二次期中分析中按年龄组划分的疗效和安全性结果。
根据盲法独立中心评估（RECIST 1.1）评估患者年龄<65 岁、≥65 岁至<75 岁和≥75 岁的 PFS 和 ORR、OS 和安全性。
在阿维鲁单抗联合阿昔替尼和舒尼替尼组中，分别有 271/138/33 和 275/128/41 名年龄<65 岁、≥65 岁至<75 岁和≥75 岁的患者被随机分组。在数据截止（2019 年 1 月）时，与舒尼替尼相比，阿维鲁单抗联合阿昔替尼在这些年龄组中的中位 PFS[95%置信区间（CI）]分别为 11.6（8.4-19.4）与 6.9（5.6-8.4）个月[风险比（HR），0.63；95%CI 0.501-0.786]、13.8（11.1-18.0）与 11.0（7.8-16.6）个月（HR，0.88；95%CI 0.627-1.231）和 13.8[7.0 无法估计（NE）]与 9.8（4.3-NE）个月（HR，0.76；95%CI 0.378-1.511）。在相应的年龄组中，中位 OS（95%CI）尚未达到（NE-NE）与 28.6（25.5-NE）个月（HR，0.74；95%CI 0.541-1.022）、30.0（30.0-NE）与 NR（NE-NE）个月（HR，0.89；95%CI 0.546-1.467）和 25.3（19.9-NE）与 NR（19.4-NE）个月（HR，0.87；95%CI 0.359-2.106）。相应年龄组的 ORR（95%CI）分别为 49.4%（43.3%至 55.6%）与 27.3%（22.1%至 32.9%）、60.9%（52.2%至 69.1%）与 28.9%（21.2%至 37.6%）和 42.4%（25.5%至 60.8%）与 22.0%（10.6%至 37.6%）。在阿维鲁单抗联合阿昔替尼组中，≥3 级不良事件（AE）和免疫相关 AE 分别在相应年龄组中发生 76.9%/81.2%/72.7%和 45.5%/48.1%/36.4%。
一线阿维鲁单抗联合阿昔替尼在包括≥75 岁患者在内的各个年龄组中均显示出良好的疗效。OS 数据仍不成熟；正在进行随访。安全性概况在各个年龄组中基本一致。
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