Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
Department of Medical Oncology, Jiangxi Cancer Hospital, The Second Affiliated Hospital of Nanchang Medical College, Jiangxi Clinical Research Center for Cancer,, Nanchang, 330029, China.
BMC Cancer. 2023 Oct 6;23(1):943. doi: 10.1186/s12885-023-11408-x.
Nephrectomy, whether in the era of cytokine therapy or targeted therapy, has an important role in the treatment of metastatic renal cell carcinoma. With the advent of immunotherapy, immunotherapy combined with targeted therapy has become the mainstream of systemic therapy, but the role of nephrectomy in metastatic renal cell carcinoma is unclear. In this study, we retrospectively analyzed the impact of nephrectomy on survival in patients with metastatic renal cell carcinoma who received immune-targeted therapy.
Patients with metastatic renal cell carcinoma who received immune-targeted therapy at three centers between May 17, 2019 and August 1, 2022 were collected, who were divided into two groups based on whether nephrectomy was performed or not. Survival, response rate and adverse event were compared between the two groups. The primary end point was progression free survival, Subgroup analysis and univariate and multivariable prognostic analyses were also assessed.
With a median follow-up time of 29.3 months (95% CI 28.5-30.2), 165 patients were recruited and divided into two groups based on whether they underwent nephrectomy or not. There were 68 patients in the non-nephrectomy group, 97 in the nephrectomy group. Compared to patients treated with immune-targeted therapy, patients treated with immune-targeted therapy plus nephrectomy were able to achieve survival benefits, with a median PFS of 10.8 months (95% CI 8.3-13.3) and 14.4 months (95% CI 12.6-16.2), respectively, as well as an HR of 0.476 (95% CI 0.323-0.701, p = 0.0002). The 12-month and 18-month PFS rates were 30.9% versus 60.8% and 7.4% versus 25.8%, respectively. The objective response rate (ORR) was 52.9% and 60.8%, respectively, in the non-nephrectomy and nephrectomy groups (p = 0.313), and the disease control rate (DCR) was 75% and 83.5%, respectively (p = 0.179). The most common adverse events related to treatment were hypothyroidism, immune-related pneumonitis and rash. Multivariate analysis showed that primary tumor nephrectomy prior to immune-targeted therapy, clear cell renal carcinoma and oligo metastasis were independent prognostic factors.
Nephrectomy may provide PFS benefit with tolerable safety for patients with metastatic renal cell carcinoma who receive immune-targeted therapy. In multivariate analysis, nephrectomy, clear cell carcinoma, and oligo-organ metastasis were found to be favorable independent prognostic factors.
肾切除术在细胞因子治疗或靶向治疗时代对转移性肾细胞癌的治疗都具有重要作用。随着免疫治疗的出现，免疫治疗联合靶向治疗已成为系统治疗的主流，但肾切除术在转移性肾细胞癌中的作用尚不清楚。在这项研究中，我们回顾性分析了肾切除术对接受免疫靶向治疗的转移性肾细胞癌患者生存的影响。
收集 2019 年 5 月 17 日至 2022 年 8 月 1 日在三个中心接受免疫靶向治疗的转移性肾细胞癌患者，根据是否进行肾切除术将患者分为两组。比较两组之间的生存、缓解率和不良事件。主要终点是无进展生存期，还进行了亚组分析和单变量及多变量预后分析。
中位随访时间为 29.3 个月（95%CI 28.5-30.2），共纳入 165 例患者，根据是否行肾切除术分为两组。非肾切除术组 68 例，肾切除术组 97 例。与接受免疫靶向治疗的患者相比，接受免疫靶向治疗联合肾切除术的患者能够获得生存获益，中位 PFS 分别为 10.8 个月（95%CI 8.3-13.3）和 14.4 个月（95%CI 12.6-16.2），HR 为 0.476（95%CI 0.323-0.701，p=0.0002）。12 个月和 18 个月的 PFS 率分别为 30.9%和 60.8%，7.4%和 25.8%。非肾切除术组和肾切除术组的客观缓解率（ORR）分别为 52.9%和 60.8%（p=0.313），疾病控制率（DCR）分别为 75%和 83.5%（p=0.179）。最常见的与治疗相关的不良事件是甲状腺功能减退、免疫相关肺炎和皮疹。多变量分析表明，免疫靶向治疗前的原发肿瘤肾切除术、透明细胞肾细胞癌和寡转移是独立的预后因素。
对于接受免疫靶向治疗的转移性肾细胞癌患者，肾切除术可能会带来 PFS 获益，且具有可耐受的安全性。多变量分析显示，肾切除术、透明细胞癌和寡转移是有利的独立预后因素。
