Adjuvant Therapy with Pembrolizumab in Renal Cell Carcinoma: Real-World Experiences from a Retrospective, Multi-Institutional Cohort.

IF 1.5 4区医学 Q3 UROLOGY & NEPHROLOGY Urologia Internationalis Pub Date : 2024-12-24 DOI:10.1159/000543278

Angelika Mattigk, Cristina Cano Garcia, Niklas Klümper, Alexander Cox, Oliver Hahn, Kerstin Junker, Kati Erdmann, Philipp Schmucker, Luka Flegar, Friedemann Zengerling, Severine Banek, Jörg Ellinger, Bjoern Thorben Buerk, Johannes Huber, Charis Kalogirou, Philip Zeuschner, Benedikt Hoeh

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Abstract

Introduction: Adjuvant pembrolizumab versus placebo significantly improved disease-free survival (DFS) in renal cell carcinoma (RCC) patients at high risk (HR) 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: Fifty-two 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), 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.

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pembrolizumab辅助治疗肾细胞癌：来自回顾性，多机构队列的真实世界经验

KEYNOTE-564试验（NCT03142334）中，辅助派姆单抗与安慰剂相比，显著提高了肾切除术后复发风险高的肾细胞癌（RCC）患者的无病生存期（DFS）。本研究的目的是在现实环境中评估辅助派姆单抗的有效性和安全性。方法：在这项多中心回顾性研究中，纳入了7个三级转诊中心于1月22日至10月23日期间接受辅助派姆单抗治疗的RCC患者。评估DFS和治疗安全性。结果：纳入了52例RCC患者。24例（46%）、5例（9.6%）、22例（42%）和1例（1.9%）患者被分为中至高危（IR至HR）、高危（HR）、M1无疾病证据（M1NED）和未知。在中位随访6个月时，整个队列6个月的DFS率为64.2%。在亚组分析中，与非转移性（IR / HR/ HR）患者相比，M1NED患者的DFS显著降低（log rank: p=0.025）。在毒性方面，26%的患者发生了3级或更高级别的不良事件。据报道，20%的患者停止治疗。结论：与KEYNOTE-564相比，M1NED组的复发率仍然很高，并且在我们的现实世界中发生的时间更早。长期毒性与临床试验数据相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Urologia Internationalis 医学-泌尿学与肾脏学

CiteScore

3.30

自引率

6.20%

发文量

审稿时长

3-8 weeks

期刊介绍： Concise but fully substantiated international reports of clinically oriented research into science and current management of urogenital disorders form the nucleus of original as well as basic research papers. These are supplemented by up-to-date reviews by international experts on the state-of-the-art of key topics of clinical urological practice. Essential topics receiving regular coverage include the introduction of new techniques and instrumentation as well as the evaluation of new functional tests and diagnostic methods. Special attention is given to advances in surgical techniques and clinical oncology. The regular publication of selected case reports represents the great variation in urological disease and illustrates treatment solutions in singular cases.