Doshi Gurjyot K, Osterland Andrew J, Shi Ping, Yim Annette, Del Tejo Viviana, Guttenplan Sarah B, Eiffert Samantha, Yin Xin, Rosenblatt Lisa, Conkling Paul R
Texas Oncology, Houston, TX.
Ontada, Boston, MA.
JCO Clin Cancer Inform. 2024 Dec;8:e2400132. doi: 10.1200/CCI.24.00132. Epub 2024 Dec 20.
Nivolumab plus ipilimumab (NIVO + IPI) is a first-in-class combination immunotherapy for the treatment of intermediate- or poor (I/P)-risk advanced or metastatic renal cell carcinoma (mRCC). Currently, there are limited real-world data regarding clinical effectiveness beyond 12-24 months from treatment initiation. In this real-world study, treatment patterns and clinical outcomes were evaluated for NIVO + IPI in a community oncology setting.
A retrospective analysis using electronic medical record data from The US Oncology Network examined patients with I/P-risk clear cell mRCC who initiated first-line (1L) NIVO + IPI between January 4, 2018, and December 31, 2019, with follow-up until June 30, 2022. Baseline demographics, clinical characteristics, treatment patterns, clinical effectiveness, and safety outcomes were assessed descriptively. Overall survival (OS) and real-world progression-free survival (rwPFS) were analyzed using Kaplan-Meier methods.
Among 187 patients identified (median follow-up, 22.4 months), with median age 63 (range, 30-89) years, 74 (39.6%) patients had poor risk and 37 (19.8%) patients had Eastern Cooperative Oncology Group performance status score ≥2. Of 86 patients who received second-line therapy, 54.7% received cabozantinib and 10.5% received pazopanib. The median (95% CI) OS and rwPFS were 38.4 (24.7-46.1) months and 11.1 (7.5-15.0) months, respectively. Treatment-related adverse events (TRAEs) were reported in 89 (47.6%) patients, including fatigue (n = 25, 13.4%) and rash (n = 19, 10.2%).
This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients with I/P-risk mRCC. TRAE rates were low relative to clinical trials.
纳武利尤单抗联合伊匹木单抗（NIVO+IPI）是用于治疗中危或低危（I/P）晚期或转移性肾细胞癌（mRCC）的一流联合免疫疗法。目前，关于治疗开始12至24个月后的临床疗效，真实世界数据有限。在这项真实世界研究中，对社区肿瘤环境中NIVO+IPI的治疗模式和临床结局进行了评估。
利用美国肿瘤学网络的电子病历数据进行回顾性分析，研究2018年1月4日至2019年12月31日期间开始一线（1L）NIVO+IPI治疗、并随访至2022年6月30日的I/P风险透明细胞mRCC患者。对基线人口统计学、临床特征、治疗模式、临床疗效和安全性结局进行描述性评估。采用Kaplan-Meier方法分析总生存期（OS）和真实世界无进展生存期（rwPFS）。
在187例纳入研究的患者中（中位随访时间为22.4个月），中位年龄63岁（范围30-89岁），74例（39.6%）患者风险低，37例（19.8%）患者东部肿瘤协作组体能状态评分≥2。在86例接受二线治疗的患者中，54.7%接受卡博替尼治疗，10.5%接受帕唑帕尼治疗。中位（95%CI）OS和rwPFS分别为38.4（24.7-46.1）个月和11.1（7.5-15.0）个月。89例（47.6%）患者报告了治疗相关不良事件（TRAEs），包括疲劳（n=25，13.4%）和皮疹（n=19，10.2%）。
本研究提供的数据有助于理解1L NIVO+IPI在I/P风险mRCC患者中的真实世界应用和长期疗效。与临床试验相比，TRAEs发生率较低。
