Memorial Sloan Kettering Cancer Center, New York, NY.
Ontada LLC, The Woodlands, TX.
Urol Oncol. 2023 Nov;41(11):459.e1-459.e8. doi: 10.1016/j.urolonc.2023.08.009. Epub 2023 Sep 17.
Immune-Oncology (IO) therapies have changed first-line (1L) treatment paradigm for metastatic renal cell carcinoma (mRCC) in last few years with robust clinical trial data. We examined clinical outcomes among clear cell mRCC (mccRCC) patients who received pembrolizumab + axitinib (pembro-axi) or ipilimumab + nivolumab (ipi-nivo) in the US community oncology setting.
This retrospective cohort study utilized data from electronic health records and chart review within The US Oncology Network to identify adult patients with mccRCC initiating 1L pembro-axi or ipi-nivo from January 01, 2019 to December 31, 2020 and followed through March 31, 2021. Physician-recorded response (real-world overall response rate [rwORR] and real-world disease control rate [rwDCR]) was assessed descriptively. Real-world progression-free survival (rwPFS), real-world time to next treatment (rwTTNT) and time on treatment (rwToT) were estimated using Kaplan-Meier analysis. Association of 1L systemic treatment with time-to-event outcomes was examined using multivariable cox proportional hazards models.
Study included 331 mccRCC patients (pembro-axi:44%, ipi-nivo:56%). Median age was 65 years, 75.5% were male, and 82.5% had intermediate/poor (I/P) IMDC risk score. RwORR and rwDCR were 71.0% and 80.0% for pembro-axi and 45.2% and 58.6% for ipi-nivo. In multivariable analysis, pembro-axi was associated with longer rwToT (aHR, 0.53 [95% CI, 0.40, 0.71]), rwTTNT (aHR, 0.60 [95% CI, 0.42, 0.87]), and rwPFS (aHR, 0.70 [95% CI, 0.49, 0.99]) compared to ipi-nivo (P < 0.01).
Our study provides insight into newer mccRCC treatment tolerability and effectiveness in the real-world US community setting. Our real-world results were comparable to data from clinical trials, which is encouraging for mccRCC patients.
免疫肿瘤学(IO)疗法在过去几年中通过大量临床试验数据改变了转移性肾细胞癌(mRCC)的一线(1L)治疗模式。我们研究了在美国社区肿瘤学环境中接受派姆单抗+阿昔替尼(pembro-axi)或伊匹单抗+纳武单抗(ipi-nivo)治疗的透明细胞 mRCC(mccRCC)患者的临床结局。
本回顾性队列研究利用美国肿瘤学网络电子病历和图表审查的数据,确定了 2019 年 1 月 1 日至 2020 年 12 月 31 日期间接受 1L pembro-axi 或 ipi-nivo 治疗的 mccRCC 成年患者,并随访至 2021 年 3 月 31 日。描述性评估医生记录的反应(真实世界总缓解率[rwORR]和真实世界疾病控制率[rwDCR])。使用 Kaplan-Meier 分析估计真实世界无进展生存期(rwPFS)、真实世界下一次治疗时间(rwTTNT)和治疗时间(rwToT)。使用多变量 Cox 比例风险模型检查 1L 系统治疗与时间相关结局的关联。
研究纳入了 331 例 mccRCC 患者(pembro-axi:44%,ipi-nivo:56%)。中位年龄为 65 岁,75.5%为男性,82.5%为中/高危(I/P)IMDC 风险评分。pembro-axi 的 rwORR 和 rwDCR 分别为 71.0%和 80.0%,ipi-nivo 分别为 45.2%和 58.6%。多变量分析显示,与 ipi-nivo 相比,pembro-axi 与更长的 rwToT(aHR,0.53[95%CI,0.40,0.71])、rwTTNT(aHR,0.60[95%CI,0.42,0.87])和 rwPFS(aHR,0.70[95%CI,0.49,0.99])相关(P<0.01)。
我们的研究提供了在现实世界的美国社区环境中,了解新型 mccRCC 治疗的耐受性和有效性的新视角。我们的真实世界结果与临床试验数据相当,这对 mccRCC 患者来说是令人鼓舞的。