近 30% 的新发肾细胞癌 (RCC) 病例在诊断时已处于晚期或转移期。最近批准的免疫疗法 (IO) 对患者护理产生了重大影响，但这些治疗的实际结果尚未得到广泛评估。符合条件的医生从患者病历中提取了晚期透明和非透明细胞肾细胞癌患者的人口统计和临床数据。 aRCC）于2018年1月1日至2020年12月31日期间开始治疗。总生存期（OS）和无进展生存期（PFS）通过Kaplan-Meier法估计。开发了多变量 Cox 回归模型来评估治疗类别对临床结果的影响，同时控制国际转移性肾细胞癌数据库联盟 (IMDC) 风险类别、组织学和其他患者特征。总共纳入 498 名患者（201 名来自美国、加拿大 62 名、英国 58 名、法国 59 名、德国 58 名、西班牙 60 名）。其中，250 例接受酪氨酸激酶抑制剂 (TKI) 单药治疗，197 例接受免疫治疗 (IO) 联合治疗（119 例 IO TKI，78 IO IO），32 例接受 IO 单药治疗作为 aRCC 的一线治疗； 19 名患者接受了各种其他治疗方案。 16% 的患者具有良好的 IMDC 风险评分。根据多变量 Cox 回归结果，PFS（风险比 [HR] [95% 置信区间 (CI)]：0.50 [0.36-0.72]）（P < .001）和下次治疗时间 (TTNT) 显着更长（ IO 联合治疗与 TKI 单药治疗患者的 HR [95% CI]：0.54 [0.39-0.73]) (P < .001)。与 TKI 单一疗法相比，IO 组合的死亡风险在数值上有所降低，但在统计学上不显着（HR：0.66；P = .114）。与 IO IO 组合相比，IO TKI 组合可显着延长 PFS 并降低进展风险（HR：0.52；P = .04）； TTNT 也观察到了类似的结果（HR：0.57；P = .03）。我们对 aRCC 的真实治疗结果的评估表明，与 TKI 单药治疗和 IO IO 组合相比，IO TKI 组合可改善 PFS 并延长 TTNT。版权所有© 2023。由爱思唯尔公司出版。

Nearly 30% of new renal cell carcinoma (RCC) cases are diagnosed at an advanced or metastatic stage. Recent approvals of immunotherapies (IO) have significantly impacted patient care, but real-world outcomes of these treatments have not been widely evaluated.Eligible physicians abstracted demographic and clinical data from patient medical records for patients with advanced clear and non-clear cell RCC (aRCC) who initiated treatment between January 1, 2018, and December 31, 2020. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. A multivariate Cox regression model was developed to assess the impact of treatment category on clinical outcomes while controlling for International Metastatic RCC Database Consortium (IMDC) risk category, histology, and other patient characteristics.A total of 498 patients were included (201 from US, 62 from Canada, 58 from UK, 59 from France, 58 from Germany, 60 from Spain). Of these, 250 received tyrosine kinase inhibitor (TKI) monotherapy, 197 received immunotherapy (IO) combination (119 IO+TKI, 78 IO+IO), and 32 received IO monotherapy as first-line treatment for aRCC; 19 patients received various other regimens. 16% of patients had a favorable IMDC risk score. Based on results of multivariable Cox regression, PFS (hazard ratio [HR] [95% confidence interval (CI)]: 0.50 [0.36-0.72]) (P < .001) and time to next treatment (TTNT) were significantly longer (HR [95% CI]: 0.54 [0.39-0.73]) (P < .001) for patients treated with IO combination versus TKI monotherapy. IO combination had a numerically reduced, but statistically insignificant, risk of death versus TKI monotherapy (HR: 0.66; P = .114). IO+TKI combination was associated with significantly longer PFS and reduced risk of progression (HR: 0.52; P = .04) versus IO+IO combination; similar results were observed for TTNT (HR: 0.57; P = .03).Our evaluation of real-world treatment outcomes in aRCC revealed that IO + TKI combination is associated with improved PFS and prolonged TTNT compared with TKI monotherapy and IO+IO combination.Copyright © 2023. Published by Elsevier Inc.