Supplementary Material for: Adjuvant therapy with pembrolizumab in renal cell carcinoma: real-world experiences from a retrospective, multi-institutional cohort

Introduction: Adjuvant pembrolizumab versus placebo significantly improved disease-free survival (DFS) in renal cell carcinoma (RCC) patients at high risk of recurrence following nephrectomy in KEYNOTE-564 trial (NCT03142334). The objective of this study was to evaluate efficacy and safety of adjuvant pembrolizumab in a real-world setting. Methods: In this multicenter retrospective study, RCC patients receiving adjuvant pembrolizumab between 01/22 and 10/23 at seven tertiary referral centers were included. DFS and treatment safety were assessed. Results: 52 patients with RCC were included. 24 (46%), 5 (9.6 %), 22 (42%) and 1 (1.9%) patients were classified as intermediate to high risk (IR to HR), high risk (HR), M1 with no evidence of disease (M1NED) and unknown. At a median follow-up of 6 months, DFS rates at 6 months were 64.2% in the overall cohort. In subgroup analyses, M1NED patients demonstrated significantly lower DFS compared to non-metastatic (combined: IR to HR/ HR) patients (log rank: p=0.025). Regarding toxicity, grade 3 or higher adverse events occurred in 26% of patients. Treatment discontinuations were reported in 20% of the patients. Conclusion: Recurrence rates in the M1NED group remained high and occurred earlier in our real-world compared to KEYNOTE-564. Long-term toxicities were comparable to clinical trials data.引言：在KEYNOTE-564试验（NCT03142334）中，辅助帕博利珠单抗对比安慰剂可显著改善肾切除术术后复发高风险肾细胞癌（renal cell carcinoma, RCC）患者的无病生存期（disease-free survival, DFS）。本研究旨在评估真实世界环境下辅助帕博利珠单抗的疗效与安全性。方法：本研究为多中心回顾性研究，纳入2022年1月至2023年10月期间，在7家三级转诊中心接受辅助帕博利珠单抗治疗的RCC患者，主要评估指标为无病生存期与治疗安全性。结果：本研究共纳入52例RCC患者。其中，中至高风险（intermediate to high risk, IR至HR）、高风险（high risk, HR）、无疾病证据的转移性（metastatic with no evidence of disease, M1NED）以及未知风险分层的患者分别为24例（46%）、5例（9.6%）、22例（42%）与1例（1.9%）。中位随访6个月时，全队列的6个月无病生存率为64.2%。亚组分析显示，无疾病证据的转移性患者的无病生存期显著低于非转移性（合并中至高风险/高风险）患者（对数秩检验：p=0.025）。毒性相关数据显示，26%的患者出现3级及以上不良事件，20%的患者报告了治疗中断。结论：本真实世界队列中，无疾病证据的转移性组复发率仍处于较高水平，且复发时间较KEYNOTE-564试验更早；长期毒性反应与临床试验数据相当。