Hôpital Européen Georges-Pompidou, Assistance Publique⬜Hôpitaux de Paris, Paris, France.
Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
Eur Urol. 2021 Oct;80(4):417-424. doi: 10.1016/j.eururo.2021.06.009. Epub 2021 Jun 27.
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).
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.
Patients in the intention-to-treat population received nephrectomy⬜sunitinib (standard of care [SOC]; n = 226) or sunitinib alone (n = 224).
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.
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.
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.
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.
CARMENA 试验纳入转移性肾细胞癌（mRCC）患者，结果表明，舒尼替尼单药治疗不劣于肾切除术联合舒尼替尼（手术⬜舒尼替尼）。
本研究旨在提供 CARMENA 的更新总生存（OS）结果，并评估某些亚组是否仍可能从初始肾切除术获益。
设计、地点和参与者：CARMENA 是一项 2009 年至 2017 年入组 450 例 mRCC 患者的 III 期临床试验。
意向治疗人群中的患者接受手术⬜舒尼替尼（标准治疗[SOC]；n=226）或舒尼替尼单药治疗（n=224）。
主要终点为 OS，采用更新的数据截止时间（2018 年 10 月；中位 OS 无事件随访时间，36.6 个月）评估。根据国际转移性肾细胞癌数据库联盟（IMDC）标准对患者进行风险重新分类。
舒尼替尼单药治疗不劣于手术⬜舒尼替尼（风险比[HR]，0.97；95%置信区间，0.79⬜1.19；p=0.8），中位 OS 更长（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，舒尼替尼单药治疗的 OS 显著长于手术⬜舒尼替尼（分别为 31.2 个月和 17.6 个月；HR，0.65；p=0.03）。对于具有一个 IMDC 危险因素的患者，尽管 OS 未显著长于舒尼替尼单药治疗（分别为 31.4 个月和 25.2 个月；HR，1.30；p=0.2），但手术⬜舒尼替尼的 OS 更长。亚组分析的事后性质可能限制其解释。
舒尼替尼单药治疗不劣于手术⬜舒尼替尼，提示在需要全身治疗的 mRCC 患者中，肾切除术不应作为 SOC。某些亚组，包括具有一个 IMDC 危险因素的患者，可能仍从初始肾切除术获益。
我们在临床试验中评估了转移性肾癌患者的生存情况。接受舒尼替尼单药治疗的患者与接受手术联合舒尼替尼治疗的患者的生存情况相同。我们的结论是，对于某些转移性肾癌患者，手术可能不是必需的。
