Xu Hua, Yao Xin, He Zhisong, Luo Hong, Li Guiling, Guo Jianming, Diao Lei, Fan Yu, Li Yuan, Fan Jiquan, Hu Xiaoyi, Lu Puhan, Shi Haiyan, Chen Keyan, Tan Panfeng, Fan Songhua, Shi Michael, Su Weiguo, Ye Dingwei
Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Target Oncol. 2025 Jan;20(1):113-125. doi: 10.1007/s11523-024-01120-6. Epub 2025 Jan 13.
Antiangiogenic inhibitors plus immune checkpoint inhibitors have synergistic antitumor activity and have improved treatment outcomes in patients with renal cell carcinoma (RCC).
We report the RCC cohort from a phase Ib/II study in Chinese patients evaluating the efficacy and safety of fruquintinib plus sintilimab in treating advanced clear cell RCC (ccRCC).
Eligible patients had pathologically confirmed advanced ccRCC. Patients received fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus sintilimab 200 mg every 3 weeks in 3-week cycles. The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1.
By March 31, 2023, 42 patients (median age 58.9 years; 81.0% male) had been treated in the RCC cohort. Among treatment-naive patients (n = 22), confirmed ORR was 68.2% (95% confidence interval [CI] 45.1-86.1). The median progression-free survival (PFS) was not reached, and 18-month PFS rate was 59.4%. Among previously treated patients (n = 20), the confirmed ORR was 60.0% (95% CI 36.1-80.9), and the median PFS was 15.9 (95% CI 5.4-19.3) months. All patients had adverse events related to study treatment, 52.4% of which were grade ≥ 3 in severity. Treatment-related adverse events with an incidence of ≥ 40% included proteinuria, hypothyroidism, hypercholesterolemia, hypertriglyceridemia, and hypoalbuminemia.
Fruquintinib plus sintilimab demonstrated promising efficacy in advanced ccRCC and was well tolerated. A phase III study (FRUSICA-02) using this combination regimen in patients with previously treated advanced ccRCC is ongoing.
The study was registered with ClinicalTrials.gov (NCT03903705).
抗血管生成抑制剂联合免疫检查点抑制剂具有协同抗肿瘤活性，并改善了肾细胞癌（RCC）患者的治疗效果。
我们报告了一项针对中国患者的Ib/II期研究中的RCC队列，评估呋喹替尼联合信迪利单抗治疗晚期透明细胞肾细胞癌（ccRCC）的疗效和安全性。
符合条件的患者经病理确诊为晚期ccRCC。患者接受呋喹替尼5mg，每日一次，用药2周，停药1周，联合信迪利单抗200mg，每3周一次，每3周为一个周期。主要终点是根据实体瘤疗效评价标准1.1版由研究者评估的客观缓解率（ORR）。
截至2023年3月31日，RCC队列中有42例患者（中位年龄58.9岁；81.0%为男性）接受了治疗。在初治患者（n = 22）中，确认的ORR为68.2%（95%置信区间[CI] 45.1-86.1）。中位无进展生存期（PFS）未达到，18个月PFS率为59.4%。在既往接受过治疗的患者（n = 20）中，确认的ORR为60.0%（95% CI 36.1-80.9），中位PFS为15.9（95% CI 5.4-19.3）个月。所有患者均发生了与研究治疗相关的不良事件，其中52.4%的严重程度为≥3级。发生率≥40%的治疗相关不良事件包括蛋白尿、甲状腺功能减退、高胆固醇血症、高甘油三酯血症和低白蛋白血症。
呋喹替尼联合信迪利单抗在晚期ccRCC中显示出有前景的疗效，且耐受性良好。一项在既往接受过治疗的晚期ccRCC患者中使用该联合方案的III期研究（FRUSICA-02）正在进行中。
该研究已在ClinicalTrials.gov注册（NCT03903705）。
