Department of Uro-Oncology, Saitama Medical University International Medical Center, Hidaka, Japan
Department of Diagnostic Pathology, Saitama Medical University International Medical Center, Hidaka, Japan.
Anticancer Res. 2022 May;42(5):2727-2735. doi: 10.21873/anticanres.15751.
BACKGROUND/AIM: CheckMate 214 study revealed that nivolumab plus ipilimumab combination therapy showed a strong and durable effect compared to sunitinib for patients with advanced renal cell carcinoma (aRCC). Most of the patients underwent previous nephrectomy before systemic treatment. We retrospectively investigated the clinical outcomes of Japanese patients treated with cytoreductive nephrectomy following nivolumab plus ipilimumab for aRCC.
Seventy-nine patients were treated with systemic therapy for aRCC between October 2018 and August 2021 at the Saitama Medical University International Medical Center. Ten of 61 patients treated with nivolumab plus ipilimumab underwent cytoreductive nephrectomy after the combined immunotherapy.
The median overall survival and progression-free survival were 24.3 and 15.9 months, respectively. The objective response rate was 50.8%; 9.8% of patients had a complete response, and the median time to objective response was 3.2 (range=1.3-19.7) months. The estimated percentage of patients who sustained an objective response at 30 months was 73.0%. Twenty-three patients (74%) in the complete or partial response (CR/PR) group, 11 patients (52%) in the stable disease (SD) group, and two patients (22%) in the progressive disease (PD) group had immune-related adverse events of grade 3 or higher, respectively. For all 10 patients, cytoreductive nephrectomy following nivolumab plus ipilimumab treatment were completed safely. Three patients achieved a pathological complete response without viable cancer cells. Only two patients had residual lesions on images after deferred cytoreductive nephrectomy; the remaining patients achieved radiological CR.
Cytoreductive nephrectomy after nivolumab plus ipilimumab treatment could be useful in a limited number of cases, possibly resulting in curative nephrectomy due to the durable therapeutic effect of immunotherapy.
背景/目的：CheckMate 214 研究表明，与舒尼替尼相比，纳武利尤单抗联合伊匹单抗联合治疗可为晚期肾细胞癌（aRCC）患者带来强大且持久的疗效。大多数患者在接受系统治疗前已行肾切除术。我们回顾性研究了纳武利尤单抗联合伊匹单抗治疗 aRCC 后行肾切除术的日本患者的临床结局。
2018 年 10 月至 2021 年 8 月，在埼玉医科大学国际医疗中心，79 例患者接受了 aRCC 的系统治疗。在接受纳武利尤单抗联合伊匹单抗治疗的 61 例患者中，有 10 例行肾切除术。
中位总生存期和无进展生存期分别为 24.3 个月和 15.9 个月。客观缓解率为 50.8%；9.8%的患者达到完全缓解，中位客观缓解时间为 3.2 个月（范围 1.3-19.7）。预计 30 个月时持续客观缓解的患者比例为 73.0%。完全或部分缓解（CR/PR）组 23 例（74%）、疾病稳定（SD）组 11 例（52%）、疾病进展（PD）组 2 例（22%）患者的免疫相关不良事件分别为 3 级或以上。对于所有 10 例患者，纳武利尤单抗联合伊匹单抗治疗后行肾切除术均安全完成。3 例患者达到无存活癌细胞的病理完全缓解。仅有 2 例患者在延期肾切除术后影像学上仍有残留病灶；其余患者达到影像学完全缓解。
纳武利尤单抗联合伊匹单抗治疗后行肾切除术可能对少数患者有用，由于免疫治疗的持久疗效，可能导致治愈性肾切除术。
