van Laar S A, Gombert-Handoko K B, Groenwold R H H, van der Hulle T, Visser L E, Houtsma D, Guchelaar H J, Zwaveling J
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, Netherlands.
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands.
Front Pharmacol. 2022 Mar 23;13:803935. doi: 10.3389/fphar.2022.803935. eCollection 2022.
The number of treatment options for patients with metastatic renal cell carcinoma (mRCC) has significantly grown in the last 15 years. Although randomized controlled trials are fundamental in investigating mRCC treatment efficacy, their external validity can be limited. Therefore, the efficacy of the different treatment options should also be evaluated in clinical practice. We performed a chart review of electronic health records using text mining software to study the current treatment patterns and outcomes. mRCC patients from two large hospitals in the Netherlands, starting treatment between January 2015 and May 2020, were included. Data were collected from electronic health records using a validated text mining tool. Primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method. Most frequent first-line treatments were pazopanib (n = 70), sunitinib (n = 34), and nivolumab with ipilimumab (n = 28). The overall median PFS values for first-line treatment were 15.7 months (95% confidence interval [95%CI], 8.8-20.7), 16.3 months (95%CI, 9.3-not estimable [NE]) for pazopanib, and 6.9 months (95% CI, 4.4-NE) for sunitinib. The overall median OS values were 33.4 months (95%CI, 28.1-50.9 months), 39.3 months (95%CI, 29.5-NE) for pazopanib, and 28.1 months (95%CI, 7.0-NE) for sunitinib. For nivolumab with ipilimumab, median PFS and median OS were not reached. Of the patients who finished first- and second-line treatments, 64 and 62% received follow-up treatments, respectively. With most patients starting on pazopanib and sunitinib, these real-world treatment outcomes were most likely better than in pivotal trials, which may be due to extensive follow-up treatments.
在过去15年中，转移性肾细胞癌（mRCC）患者的治疗选择数量显著增加。尽管随机对照试验对于研究mRCC治疗疗效至关重要，但其外部有效性可能有限。因此，不同治疗选择的疗效也应在临床实践中进行评估。我们使用文本挖掘软件对电子健康记录进行了图表审查，以研究当前的治疗模式和结果。纳入了2015年1月至2020年5月期间在荷兰两家大型医院开始治疗的mRCC患者。使用经过验证的文本挖掘工具从电子健康记录中收集数据。主要终点为无进展生存期（PFS）和总生存期（OS）。使用Kaplan-Meier方法进行统计分析。最常用的一线治疗药物为帕唑帕尼（n = 70）、舒尼替尼（n = 34）以及纳武利尤单抗联合伊匹木单抗（n = 28）。一线治疗的总体中位PFS值分别为15.7个月（95%置信区间[95%CI]，8.8 - 20.7），帕唑帕尼为16.3个月（95%CI，9.3 - 不可估计[NE]），舒尼替尼为6.9个月（95%CI，4.4 - NE）。总体中位OS值分别为33.4个月（95%CI，28.1 - 50.9个月），帕唑帕尼为39.3个月（95%CI，29.5 - NE），舒尼替尼为28.1个月（95%CI，7.0 - NE）。对于纳武利尤单抗联合伊匹木单抗，未达到中位PFS和中位OS。在完成一线和二线治疗的患者中，分别有64%和62%接受了后续治疗。由于大多数患者开始使用帕唑帕尼和舒尼替尼，这些真实世界的治疗结果很可能优于关键试验中的结果，这可能是由于广泛的后续治疗所致。
