Abstract：
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.
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.
摘要：
背景：近30%的新发肾细胞癌（RCC）病例诊断为晚期或转移期。最近批准的免疫疗法（IO）显著影响了患者护理，但这些治疗的实际结果尚未得到广泛评估.
方法：符合条件的医师从2018年1月1日至2020年12月31日期间开始治疗的晚期透明和非透明细胞RCC（aRCC）患者的患者病历中提取了人口统计学和临床数据。通过Kaplan-Meier方法估计总生存期(OS)和无进展生存期(PFS)。开发了多变量Cox回归模型，以评估治疗类别对临床结果的影响，同时控制国际转移性肾癌数据库联盟（IMDC）风险类别。组织学,和其他患者特征。
结果：共纳入498例患者（美国201例，来自加拿大的6258来自英国，59来自法国，58来自德国，60来自西班牙）。其中,250人接受酪氨酸激酶抑制剂（TKI）单药治疗，197人接受了免疫治疗（IO）组合（119IO+TKI，78IO+IO)，32例患者接受了IO单药治疗作为aRCC的一线治疗;19例患者接受了各种其他方案.16%的患者有良好的IMDC风险评分。根据多变量Cox回归的结果，IO联合治疗与TKI单药治疗患者的PFS（风险比[HR][95％置信区间（CI）]：0.50[0.36-0.72]）（P<.001）和下一次治疗时间（TTNT）明显更长（HR[95％CI]：0.54[0.39-0.73]）（P<.001）。IO组合在数值上有所减少，但统计上微不足道，与TKI单药治疗相比，死亡风险（HR：0.66；P=.114）。与IO+IO组合相比，IO+TKI组合与显著延长的PFS和降低的进展风险(HR:0.52;P=.04)相关；对于TTNT观察到类似的结果(HR:0.57;P=.03)。
结论：我们对aRCC真实世界治疗结果的评估显示，与TKI单药和IO+IO联合治疗相比，IO+TKI联合治疗与改善的PFS和延长的TTNT相关。
方法：符合条件的医师从2018年1月1日至2020年12月31日期间开始治疗的晚期透明和非透明细胞RCC（aRCC）患者的患者病历中提取了人口统计学和临床数据。通过Kaplan-Meier方法估计总生存期(OS)和无进展生存期(PFS)。开发了多变量Cox回归模型，以评估治疗类别对临床结果的影响，同时控制国际转移性肾癌数据库联盟（IMDC）风险类别。组织学,和其他患者特征。
结果：共纳入498例患者（美国201例，来自加拿大的6258来自英国，59来自法国，58来自德国，60来自西班牙）。其中,250人接受酪氨酸激酶抑制剂（TKI）单药治疗，197人接受了免疫治疗（IO）组合（119IO+TKI，78IO+IO)，32例患者接受了IO单药治疗作为aRCC的一线治疗;19例患者接受了各种其他方案.16%的患者有良好的IMDC风险评分。根据多变量Cox回归的结果，IO联合治疗与TKI单药治疗患者的PFS（风险比[HR][95％置信区间（CI）]：0.50[0.36-0.72]）（P<.001）和下一次治疗时间（TTNT）明显更长（HR[95％CI]：0.54[0.39-0.73]）（P<.001）。IO组合在数值上有所减少，但统计上微不足道，与TKI单药治疗相比，死亡风险（HR：0.66；P=.114）。与IO+IO组合相比，IO+TKI组合与显著延长的PFS和降低的进展风险(HR:0.52;P=.04)相关；对于TTNT观察到类似的结果(HR:0.57;P=.03)。
结论：我们对aRCC真实世界治疗结果的评估显示，与TKI单药和IO+IO联合治疗相比，IO+TKI联合治疗与改善的PFS和延长的TTNT相关。
