Objectives

To assess whether the clinical outcome of advanced/metastatic renal cell carcinoma (mRCC) treated with sorafenib, in real-world conditions, differs in patients with cardiovascular disease (CVD).

Methods

mRCC patients (n = 2256 before matching) were matched by propensity score into CVD (n = 560) and non-CVD groups (n = 560), followed by safety and effectiveness analyzes.

Results

After matching, patients’ features used for matching were balanced between the CVD and non-CVD groups, except for age (p = 0.0049). Renal comorbidity occurred more frequently in the CVD group. Exposure to sorafenib and objective response rate (25.4% [CVD], 28.5% [non-CVD]) were comparable in both groups. Median progression-free survival (PFS; 7.1 months, 95% CI: 6.4–8.6 [CVD]; 6.7 months, 6.3–8.3 [non-CVD]), and hazard ratios for PFS (0.954, 0.821–1.108) and overall survival (0.889, 0.683–1.156), were similar in the matched population. The incidences of adverse drug reactions (ADR, ≥10%) were generally similar between groups, although hypertension (42.1% vs 34.5%), diarrhea (26.3% vs 19.6%), decreased appetite (11.3% vs 7.5%), and non-serious and serious renal failure/dysfunction (3.6% vs 1.4% and 1.8% vs 0.4%), occurred more frequently in the CVD group.

Conclusion

This analyzes suggests that sorafenib has clinical benefit for mRCC patients regardless of baseline CVD. Serious ADRs increased for renal dysfunction.

Clinical trial registration

www.clinicaltrials.gov identifier is NCT01411423.

中文翻译：

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索拉非尼在患有心血管疾病的晚期肾细胞癌患者中的实际应用：日本的全国调查。

目标

为了评估在实际情况下用索拉非尼治疗的晚期/转移性肾细胞癌（mRCC）的临床结果在心血管疾病（CVD）患者中是否有所不同。

方法

将mRCC患者（匹配前为n = 2256）与CVD（n = 560）和非CVD组（n = 560）的倾向得分进行匹配，然后进行安全性和有效性分析。

结果

匹配后，除年龄外，CVD和非CVD组之间用于匹配的患者特征是平衡的（p = 0.0049）。肾脏合并症在CVD组中更常见。两组的索拉非尼暴露率和客观缓解率（25.4％[CVD]，28.5％[non-CVD]）相当。中位无进展生存期（PFS; 7.1个月，95％CI：6.4–8.6 [CVD]; 6.7个月，6.3–8.3 [non-CVD]），PFS的危险比（0.954，0.821-1.108）和总体生存率（0.889，0.683–1.156）在匹配人群中相似。两组之间的药物不良反应发生率（ADR，≥10％）大致相似，尽管高血压（42.1％vs 34.5％），腹泻（26.3％vs 19.6％），食欲下降（11.3％vs 7.5％）和非-严重和严重的肾衰竭/功能障碍（3.6％比1.4％和1.8％比0.4％），

结论

该分析表明索拉非尼对mRCC患者具有临床益处，而与基线CVD无关。肾功能不全的严重不良反应增加。

临床试验注册

www.clinicaltrials.gov的标识符是NCT01411423。