Oregon Health & Science University, Department of Urology, Portland, OR.
Oregon Health & Science University, Department of Urology, Portland, OR.
Urol Oncol. 2020 Jun;38(6):604.e1-604.e7. doi: 10.1016/j.urolonc.2020.02.028. Epub 2020 Mar 31.
The appropriate use of adjuvant targeted therapy (TT) for high-risk locoregional renal cell carcinoma (RCC) after nephrectomy is currently unclear due to mixed results from the relevant randomized controlled trials. National-level survival outcomes and practice trends for the use of adjuvant TT in the United States have not been reported.
To compare overall survival for patients who did and did not receive adjuvant TT after nephrectomy for high-risk locoregional RCC.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study reviewed the National Cancer Database from 2006 to 2015. Patients with nonmetastatic clear cell RCC who underwent nephrectomy with either stage pT3a or greater or pN+ were included.
Adjuvant TT was defined as receipt of TT within 3 months of nephrectomy. The primary end point was overall survival from initial diagnosis to date of death or censored at last follow-up. Baseline characteristics were described, and a multivariable analysis identified associations for receipt of adjuvant TT. Nearest-neighbor propensity matching was performed to create similar groups for comparison. A survival analysis was performed using Kaplan-Meier analysis and log-rank test.
The final study population included 41,127 patients. Two thousand seventy-one patients (5.04%) received off-label adjuvant TT. Younger age, white race, private insurance, positive margins, pT4, and pN+ were associated with receipt of adjuvant TT. After nearest-neighbor propensity matching for clinically and statistically relevant covariates, 1,604 patients remained in the matched cohort, with statistically nonsignificant differences between the groups for all baseline characteristics. Median overall survival was 52 months for patients in the Adjuvant TT group versus 79 months for those who did not receive adjuvant TT (P < 0.001). Decreased overall survival for patients receiving adjuvant therapy was also seen in pathologic subgroups with and without lymph node involvement.
The propensity matched survival analysis revealed significantly decreased overall survival in patients who received off-label adjuvant TT for high-risk locoregional RCC.
由于相关随机对照试验的结果存在差异，目前对于肾切除术后高危局部区域肾细胞癌（RCC）患者合适的辅助靶向治疗（TT）的应用尚不清楚。美国关于辅助 TT 在国家层面的生存结果和应用趋势尚未有报道。
比较肾切除术后接受和未接受辅助 TT 的高危局部区域 RCC 患者的总生存情况。
设计、设置和参与者：本队列研究回顾了 2006 年至 2015 年的国家癌症数据库。纳入接受肾切除术的非转移性透明细胞 RCC 患者，分期为 pT3a 或更高或 pN+。
辅助 TT 定义为肾切除术后 3 个月内接受 TT。主要终点是从初始诊断到死亡或最后一次随访的日期的总生存。描述了基线特征，并进行了多变量分析以确定接受辅助 TT 的关联。采用最近邻倾向匹配法创建相似的组进行比较。采用 Kaplan-Meier 分析和对数秩检验进行生存分析。
最终研究人群包括 41127 例患者。2071 例（5.04%）患者接受了标签外的辅助 TT。年轻、白种人、私人保险、切缘阳性、pT4 和 pN+与接受辅助 TT 相关。在对临床和统计学上相关的协变量进行最近邻倾向匹配后，在匹配队列中仍有 1604 例患者，两组间所有基线特征均无统计学差异。辅助 TT 组患者的中位总生存期为 52 个月，而未接受辅助 TT 组患者的中位总生存期为 79 个月（P<0.001）。在有和无淋巴结受累的病理亚组中，接受辅助治疗的患者的总生存也降低。
倾向性匹配生存分析显示，接受辅助 TT 治疗高危局部区域 RCC 的患者总生存显著降低。
