Background

The CARMENA trial in patients with metastatic renal cell carcinoma (mRCC) demonstrated that treatment with sunitinib alone was noninferior to cytoreductive nephrectomy (CN) followed by sunitinib (nephrectomy⬜sunitinib).

Objective

The objective of this study was to provide updated overall survival (OS) outcomes of CARMENA and assess whether some subgroups may still benefit from upfront CN.

Design, setting, and participants

CARMENA was a phase III trial in 450 patients with mRCC enrolled from 2009 to 2017.

Intervention

Patients in the intention-to-treat population received nephrectomy⬜sunitinib (standard of care [SOC]; n = 226) or sunitinib alone (n = 224).

Outcome measurements and statistical analysis

Primary endpoint was OS, assessed using an updated data cut-off (October 2018; median OS event-free follow-up, 36.6 mo). Patients were reclassified by risk using International Metastatic RCC Database Consortium (IMDC) criteria.

Results and limitations

Sunitinib alone was noninferior to nephrectomy⬜sunitinib (hazard ratio [HR], 0.97; 95% confidence interval, 0.79⬜1.19; p = 0.8) and demonstrated longer median OS (19.8 mo vs 15.6 mo, respectively). For patients with two or more IMDC risk factors, OS was significantly longer with sunitinib alone than with nephrectomy⬜sunitinib (31.2 mo vs 17.6 mo, respectively; HR, 0.65; p = 0.03). For patients with one IMDC risk factor, OS was longer for nephrectomy⬜sunitinib versus sunitinib alone although not significantly (31.4 mo vs 25.2 mo; HR, 1.30; p = 0.2). The post hoc nature of the subgroup analyses may limit their interpretation.

Conclusions

Sunitinib alone was noninferior compared with nephrectomy⬜sunitinib, suggesting that CN should not be considered SOC in patients with mRCC requiring systemic treatment. Certain subgroups, including patients with one IMDC risk factor, may still benefit from upfront CN.

Patient summary

We assessed the survival of patients with metastatic kidney cancer in a clinical trial. Patients treated with sunitinib on its own had the same survival as patients who had surgery before sunitinib treatment. We conclude that surgery may not be necessary for some patients with metastatic kidney cancer.

中文翻译：

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转移性肾细胞癌患者单独使用舒尼替尼或肾切除术后：细胞减灭性肾切除术还有作用吗？

背景

在转移性肾细胞癌 (mRCC) 患者中进行的 CARMENA 试验表明，单独使用舒尼替尼治疗不劣于细胞减灭性肾切除术 (CN) 继以舒尼替尼（肾切除术⬜舒尼替尼）。

客观的

本研究的目的是提供更新的 CARMENA 总生存期 (OS) 结果，并评估某些亚组是否仍可从前期 CN 中受益。

设计、设置和参与者

CARMENA 是一项 III 期试验，在 2009 年至 2017 年期间招募了 450 名 mRCC 患者。

干涉

意向治疗人群中的患者接受了肾切除术⬜舒尼替尼（护理标准 [SOC]；n  = 226）或单用舒尼替尼（n  = 224）。

结果测量和统计分析

主要终点是 OS，使用更新的数据截止值进行评估（2018 年 10 月；中位 OS 无事件随访，36.6 个月）。使用国际转移性 RCC 数据库联盟 (IMDC) 标准按风险对患者进行重新分类。

结果和局限性

单独使用舒尼替尼不劣于肾切除术⬜舒尼替尼（风险比 [HR]，0.97；95% 置信区间，0.79⬜1.19；p  = 0.8）并且显示出更长的中位 OS（分别为 19.8 个月和 15.6 个月）。对于具有两个或更多 IMDC 危险因素的患者，单用舒尼替尼的 OS 显着长于肾切除术⬜舒尼替尼（分别为 31.2 个月和 17.6 个月；HR，0.65；p  = 0.03）。对于具有一项 IMDC 风险因素的患者，肾切除术⬜舒尼替尼与单独舒尼替尼相比，OS 更长，尽管不显着（31.4 个月对 25.2 个月；HR，1.30；p  = 0.2）。亚组分析的事后性质可能会限制其解释。

结论

与肾切除术⬜舒尼替尼相比，单用舒尼替尼不劣于肾切除术⬜舒尼替尼，这表明在需要全身治疗的 mRCC 患者中不应将 CN 视为 SOC。某些亚组，包括具有一种 IMDC 风险因素的患者，仍可能从前期 CN 中受益。

患者总结

我们在一项临床试验中评估了转移性肾癌患者的生存率。单独接受舒尼替尼治疗的患者与接受舒尼替尼治疗前接受手术的患者具有相同的生存率。我们得出结论，一些转移性肾癌患者可能不需要手术。