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Efficacy of sorafenib adjuvant therapy in northwestern Chinese patients with non-metastatic renal-cell carcinoma after nephrectomy

机译:索拉非尼辅助治疗在中国西北地区非转移性肾细胞癌患者术后的疗效

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摘要

Recent studies have confirmed the efficacy of sorafenib for patients with advanced renal cell carcinoma; however, its efficacy and safety as an adjuvant therapy in patients with non-metastatic and loco-regional renal cell carcinoma after surgery remains controversial. Thus, the aim of the present retrospective study was to evaluate the efficacy of adjuvant sorafenib therapy in such patients from 8 centers in northwestern China that were treated from August 2009 to December 2016.After surgery, the patients (n = 48) received oral sorafenib for 3 months. The control group (n = 48) comprised patients that underwent the same surgery from December 2009 to June 2016 but without adjuvant therapy who were matched 1:1 with the sorafenib group with respect to sex, age, pathological findings, disease stage and grade, operation time, and surgical procedure. The primary outcome compared between the groups was disease-free survival. Adverse events were also recorded to evaluate the safety of sorafenib. The influence of patients’ characteristics and laboratory tests on recurrence was analyzed using unconditional logistic regression.Overall, the demographic characteristics of the 2 groups were similar. There was no significant difference in the rate of recurrence (8.3% for sorafenib patients and 6.2% for the matched patients, P = .66) or median disease-free survival between the 2 groups (hazard ratio = 1.561, 95% confidence interval = 0.349–6.987, P = .56). In multiple logistic regression analysis, increased blood urea nitrogen (BUN) emerged as an independent predictor of recurrence risk (P = .02).These results indicate that postoperative sorafenib adjuvant therapy did not achieve the expected beneficial effect, pointing to the need for further studies to evaluate its utility in such cases.
机译:最近的研究证实索拉非尼对晚期肾细胞癌的疗效。然而,其在手术后非转移性和局部区域性肾细胞癌患者中作为辅助治疗的疗效和安全性仍存在争议。因此,本回顾性研究的目的是评估2009年8月至2016年12月在中国西北8个中心接受此类治疗的患者的辅助索拉非尼治疗的疗效。手术后,患者(n = 48)接受口服索拉非尼治疗3个月。对照组(n = 48)包括从2009年12月至2016年6月接受相同手术但无辅助治疗的患者,这些患者在性别,年龄,病理表现,疾病分期和等级方面与索拉非尼组1:1匹配,手术时间和手术程序。两组之间比较的主要结果是无病生存。还记录了不良事件以评估索拉非尼的安全性。使用无条件逻辑回归分析了患者特征和实验室检查对复发的影响。总体而言,两组的人口统计学特征相似。两组之间的复发率(索拉非尼患者为8.3%,配对患者为6.2%,P = .66)或中位无病生存率无显着差异(危险比= 1.561,95%置信区间= 0.349–6.987,P = .56)。在多元logistic回归分析中,血尿素氮(BUN)升高是复发风险的独立预测因子(P = .02),这些结果表明术后索拉非尼辅助治疗未能达到预期的有益效果,这表明需要进一步治疗研究以评估其在这种情况下的效用。

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