Primary tumour response may impact therapeutic strategies in metastatic renal cell carcinoma (mRCC) but remains unknown in the era of immune checkpoint inhibitors. We aimed to describe the response of the primary tumour in patients who did not undergo upfront cytoreductive nephrectomy (uCN) and were treated with nivolumab in the GETUG-AFU-26 NIVOREN phase 2 trial. Primary tumour response was prospectively assessed, as well as the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Among 720 patients, 111 did not undergo uCN, mainly patients with intermediate (45%) and poor (49%) International mRCC Database Consortium (IMDC) risk. In the 111 patients, nivolumab was used in the second line for 63% of patients and the third line or more for 37%, with an ORR of 16% (95% confidence interval [CI] 1025%); with a median follow-up of 24.5 mo (95% CI 21.6–27.1), median PFS was 2.7 mo (95% CI 2.5–4.0) and median OS was 15.9 mo (95% CI 9.5–19.8). A total of 67 patients had an evaluable primary renal lesion, four of whom (6%) experienced shrinkage of more than 30%. Overall, patients who did not undergo uCN had adverse baseline characteristics and nivolumab activity against the primary tumour was limited.

Patient summary

In this report, we observed that nivolumab was associated with a limited response of the primary tumour in previously treated patients with metastatic kidney cancer.

中文翻译：

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接受 Nivolumab 治疗转移性肾细胞癌患者的原发性肾肿瘤反应：GETUG-AFU 26 NIVOREN 试验的结果

原发性肿瘤反应可能会影响转移性肾细胞癌 (mRCC) 的治疗策略，但在免疫检查点抑制剂时代仍然未知。我们旨在描述在 GETUG-AFU-26 NIVOREN 2 期试验中未接受前期细胞减灭性肾切除术 (uCN) 并接受纳武单抗治疗的患者的原发肿瘤反应。前瞻性评估了原发性肿瘤反应，以及总反应率（ORR）、无进展生存期（PFS）和总生存期（OS）。在 720 名患者中，111 名未接受 uCN，主要是具有中等 (45%) 和差 (49%) 国际 mRCC 数据库联盟 (IMDC) 风险的患者。在 111 名患者中，63% 的患者在二线使用纳武利尤单抗，37% 的患者使用三线或更多，ORR 为 16%（95% 置信区间 [CI] 1025%）；中位随访时间为 24.5 个月（95% CI 21.6-27.1），中位 PFS 为 2.7 个月（95% CI 2.5-4.0），中位 OS 为 15.9 个月（95% CI 9.5-19.8）。共有 67 名患者有可评估的原发性肾病灶，其中 4 名 (6%) 的缩小超过 30%。总体而言，未接受 uCN 的患者具有不良的基线特征，并且 nivolumab 对原发性肿瘤的活性有限。

患者总结

在本报告中，我们观察到 nivolumab 与先前治疗的转移性肾癌患者原发肿瘤的有限反应有关。