Department of Graduate, Bengbu Medical College, Bengbu, China.
Eur Rev Med Pharmacol Sci. 2023 Jun;27(12):5684-5691. doi: 10.26355/eurrev_202306_32808.
This study was performed to evaluate the efficacy of immediate cytoreductive nephrectomy (CRN) followed by programmed cell death factor-1 (PD-1) inhibitors vs. deferred CRN after the administration of 4 cycles of neoadjuvant therapy using nivolumab preceding the debulking and postoperative chemotherapy in metastatic renal cell carcinoma (mRCC).
We recruited 84 patients with primary mRCC admitted to our Oncology Department from 2018 to 2020 and randomized them 1:1 to receive either CRN followed by nivolumab (control group) or 4 cycles of neoadjuvant therapy using nivolumab before CRN and postoperative chemotherapy (study group), with 42 patients in each group. The primary clinical endpoints were the clinical efficacy and safety of the PD-1 antibody. Clinical outcomes were assessed 3 months after treatment.
Patients were followed-up for 10-52 months, with a median follow-up period of 40.50 months. The control group reported 2 cases of complete remission and 10 cases of partial remission, with an objective response rate (ORR) of 28.57% (12/42). The study group reported 4 cases of complete remission and 14 cases of partial remission with an ORR of 42.86% (18/42). No significant differences in the ORR were identified between the two groups (p > 0.05). Progression-free survival of the patients was significantly extended from 30 months (19-51) to 43 months (38-76) after administrating the PD-1 inhibitors before the debulking (HR = 0.501, 95% CI: 0.266 to 0.942). There were no significant differences in the median survival of patients between the two groups [44 months (38-79) vs. 44 months (32-81)] (HR = 0.814, 95% CI: 0.412 to 1.612). The two protocols had a similar safety profile.
Nivolumab administration preceding delayed CRN provides significant progression-free survival benefits for patients with mRCC, but its impact on overall survival requires further investigations.
本研究旨在评估在转移性肾细胞癌（mRCC）患者中，在去瘤手术（CRN）前使用纳武单抗进行 4 个周期新辅助治疗，随后进行程序性死亡因子-1（PD-1）抑制剂治疗与在新辅助治疗后进行 CRN 的疗效。
我们招募了 2018 年至 2020 年期间在我院肿瘤内科就诊的 84 例原发性 mRCC 患者，并将其随机分为 1:1 组，分别接受 CRN 后纳武单抗治疗（对照组）或 CRN 前使用纳武单抗进行 4 个周期新辅助治疗和术后化疗（研究组），每组 42 例。主要临床终点是 PD-1 抗体的临床疗效和安全性。治疗后 3 个月评估临床结局。
患者的随访时间为 10-52 个月，中位随访时间为 40.50 个月。对照组有 2 例完全缓解和 10 例部分缓解，客观缓解率（ORR）为 28.57%（12/42）。研究组有 4 例完全缓解和 14 例部分缓解，ORR 为 42.86%（18/42）。两组 ORR 无显著差异（p>0.05）。在去瘤手术前使用 PD-1 抑制剂可显著延长患者的无进展生存期，从 30 个月（19-51）延长至 43 个月（38-76）（HR=0.501，95%CI：0.266 至 0.942）。两组患者的中位总生存期无显著差异[44 个月（38-79）比 44 个月（32-81）]（HR=0.814，95%CI：0.412 至 1.612）。两种方案的安全性相似。
在延迟 CRN 前使用纳武单抗可显著改善 mRCC 患者的无进展生存期，但对总生存期的影响需要进一步研究。
