Hu Ke, Ma Ming-Wei, Gao Xian-Shu, Li Hong-Zhen, Chen Jia-Yan, Li Xiao-Ying, Qin Shang-Bin, Ren Xue-Ying
Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing 100034, P.R. China.
Oncol Lett. 2025 Jun 2;30(2):376. doi: 10.3892/ol.2025.15122. eCollection 2025 Aug.
The present study aimed to investigate the safety and efficacy of the combination of axitinib, toripalimab and stereotactic ablative body radiotherapy (SABR) in the treatment of recurrent or metastatic renal cell carcinoma (RCC). The present study was a single-center, prospective study in which all patients received a treatment regimen consisting of axitinib combined with toripalimab and comprehensive multi-lesion SABR. The primary endpoint was progression-free survival (PFS)1 (start of radiotherapy to first disease progression), while secondary endpoints included PFS2 (start of radiotherapy to second-line systemic treatment due to disease progression), overall survival (OS), local control, objective response rate (ORR) and disease control rate (DCR). Adverse events were assessed according to the Common Terminology Criteria for Adverse Events version 5.0. A total of 30 patients were enrolled, of whom 21 (70.0%) had clear cell carcinoma and 23 (76.7%) had oligometastatic disease. The median follow-up time was 17.8 months (range, 1.2-47.7 months). The overall ORR was 60.0%, and the DCR was 80.0%, with a DCR of 96.7% for the irradiated lesions and 83.3% for the non-irradicated lesions. The median PFS1 time was 20.3 months (95% CI, 5.2-35.4 months), and the median OS was 44.8 months (95% CI, 20.0-69.6 months), while the median PFS2 time was not reached. As of September 2024, 24 out of 30 patients remained alive, with 15 experiencing disease progression. Subgroup analysis revealed that PFS1 was significantly longer when radiotherapy was administered before treatment failure compared with after (28.6 vs. 6.9 months; P=0.014). Regarding adverse events, the most common were diarrhea and fatigue, with grade ≥3 adverse events occurring in 50.0% of patients. In conclusion, mid-term analysis results show that the combination therapy of axitinib, toripalimab and SABR has achieved satisfactory survival outcomes in patients with recurrent or metastatic RCC, with manageable adverse reactions. Long-term follow-up data are still needed for validation. The present trial was retrospectively at clinicaltrials.gov (registration no. NCT06889649; 03-03-2025).
本研究旨在探讨阿昔替尼、托瑞帕利单抗和立体定向消融体部放疗（SABR）联合治疗复发性或转移性肾细胞癌（RCC）的安全性和有效性。本研究是一项单中心前瞻性研究，所有患者均接受由阿昔替尼联合托瑞帕利单抗及多病灶综合SABR组成的治疗方案。主要终点为无进展生存期（PFS）1（从放疗开始至首次疾病进展），次要终点包括PFS2（从放疗开始至因疾病进展进行二线全身治疗）、总生存期（OS）、局部控制、客观缓解率（ORR）和疾病控制率（DCR）。根据《不良事件通用术语标准》第5.0版评估不良事件。共纳入30例患者，其中21例（70.0%）为透明细胞癌，23例（76.7%）为寡转移疾病。中位随访时间为17.8个月（范围1.2 - 47.7个月）。总体ORR为60.0%，DCR为80.0%，照射病灶的DCR为96.7%，未照射病灶的DCR为83.3%。中位PFS1时间为20.3个月（95%CI，5.2 - 35.4个月），中位OS为44.8个月（95%CI，20.0 - 69.6个月），而中位PFS2时间未达到。截至2024年9月，30例患者中有24例仍存活，15例出现疾病进展。亚组分析显示，与治疗失败后相比，在治疗失败前进行放疗时PFS1显著更长（28.6对6.9个月；P = 0.014）。关于不良事件，最常见的是腹泻和疲劳，50.0%的患者发生≥3级不良事件。总之，中期分析结果表明，阿昔替尼、托瑞帕利单抗和SABR联合治疗在复发性或转移性RCC患者中取得了令人满意的生存结果，不良反应可控。仍需要长期随访数据进行验证。本试验在clinicaltrials.gov上进行了回顾性注册（注册号NCT06889649；2025年3月3日）。
