Conditional Survival in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab
Conditional Survival in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab
复制标题
接受纳武单抗治疗的晚期肾细胞癌患者的条件生存
DOI：
10.12659/msm.916984
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发表时间：
2019-08-30
影响因子：
3.1
通讯作者：
Ye, Dingwei
中科院分区：
文献类型：
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作者：
Shao, Ning;Wan, Fangning;Ye, Dingwei
Nivolumab被批准用于晚期肾细胞癌（RCC）的治疗。然而，传统的总生存期（OS）或无进展生存期（PFS）并不能反映患者初始治疗后的预后。因此，本研究旨在评估nivolumab治疗的晚期RCC患者的条件总生存期（COS）和条件无进展生存期（CPFS）。材料/方法847例晚期RCC患者采用一线纳武单抗联合伊匹单抗（n=425）和舒尼替尼（n=422）治疗，821例患者采用二线纳武单抗联合依维莫司（n=410）治疗。主要终点为COS和CPFS。从两个大型随机对照试验（CheckMate 025和CheckMate 214）中数字化重建PFS和OS的个体患者数据。结果在一线治疗中，与舒尼替尼相比，纳沃单抗联合伊匹单抗组在生存0.5年和0.75年后的1年CPFS改善率分别为14%（从53.0%提高到67.0%）和16%（从57.0%提高到73.0%），而1年PFS的改善率为6.5%（从42.9%提高到49.4%），一线治疗后1年COS的结果相似。对于二线治疗，与依维莫司相比，纳武单抗组生存0.5年和0.75年后一年CPFS的改善分别为19%（从25.0%到44.0%）和19%（从27.0%到46.0%），显著高于一年PFS的4.5%（从18.5%到23.0%）。结论与舒尼替尼相比，纳武单抗（联合伊匹单抗）对晚期RCC患者的生存获益更明显，一线治疗的条件生存（CS）分析。
Background Nivolumab is approved for the treatment of advanced renal cell carcinoma (RCC). However, traditional overall survival (OS) or progression-free survival (PFS) do not reflect patient prognosis after initial management. Therefore, this study aimed to evaluate conditional overall survival (COS) and conditional progression-free survival (CPFS) in patients with advanced RCC treated with nivolumab. Material/Methods There were 847 patients with advanced RCC treated with first-line nivolumab plus ipilimumab (n=425) and sunitinib (n=422), and 821 patients were treated with second-line nivolumab (n=410) and everolimus (n=411). Primary endpoints were COS and CPFS. Individual patient data of PFS and OS were digitally reconstructed from two large randomized controlled trials (CheckMate 025 and CheckMate 214). Results In first-line treatment, compared with sunitinib, improvement of one-year CPFS for the nivolumab plus ipilimumab group after living for 0.5 and 0.75 years were 14% (from 53.0% to 67.0%) and 16% (from 57.0% to 73.0%) higher than the one-year PFS of 6.5% (from 42.9% to 49.4%), with similar results for one-year COS following first-line treatment. For second-line treatment, compared with everolimus, the improvement of one-year CPFS for the nivolumab group after living for 0.5 and 0.75 years were 19% (from 25.0% to 44.0%) and 19% (from 27.0% to 46.0%) and significantly higher than the one-year PFS of 4.5% (from 18.5% to 23.0%). Conclusions Survival benefit for patients with advanced RCC from nivolumab (plus ipilimumab) compared with sunitinib was more evident from conditional survival (CS) analysis of first-line treatment.