Clinical efficacy observation of postoperative adjuvant tislelizumab therapy in high-risk renal cell carcinoma
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摘要: 目的 评估替雷利珠单抗作为高危肾细胞癌(renal cell carcinoma，RCC)患者术后辅助治疗的临床效果和安全性。方法 辽宁省肿瘤医院泌尿外科自2021年11月—2024年1月共26例高危肾透明细胞癌患者在肾切除术后接受了替雷利珠单抗单药治疗。治疗剂量为每3周200 mg，连续6个周期，根据患者耐受性可调整剂量。之后连续随访并记录治疗相关不良反应。结果 26例患者中，88.46%的患者完成了全部治疗方案，11.54%的患者因不良反应调整了剂量。中位随访时间为15个月，6个月无病生存期(disease-free survival，DFS)率为100%，12个月DFS率为87.5%。未有患者因不良事件中断治疗。观察到的主要不良事件包括乏力、瘙痒、甲状腺功能减退等，大多数为1~2级，3例患者出现3级不良事件后经调整剂量顺利完成治疗。结论 短期随访提示替雷利珠单抗对于高危RCC术后辅助治疗显示出良好的DFS获益趋势，且不良反应可控，但仍需较长期、大规模研究进一步证实。Abstract: Objective To evaluate the clinical efficacy and safety of tislelizumab as an adjuvant therapy for patients with high-risk renal cell carcinoma (RCC) following surgery.Methods From November 2021 to January 2024, a total of 26 patients with high-risk clear cell renal carcinoma in the Department of Urology of Liaoning Cancer Hospital received monotherapy with tislelizumab after nephrectomy. The treatment dosage was 200 mg every 3 weeks for 6 cycles, with dose adjustments based on patient tolerance. Subsequent follow-up and recording of treatment-related adverse reactions were conducted.Results Among the 26 patients, 88.46% completed the entire treatment regimen, and 11.54% had their dosage adjusted due to adverse reactions. The median follow-up time was 15 months, with a 6-month disease-free survival(DFS) of 100% and a 12-month DFS of 87.5%. No patients discontinued treatment due to adverse events. The main adverse events observed included fatigue, itching, and hypothyroidism, mostly grades 1 to 2. Three patients with grade 3 adverse events successfully completed treatment after dosage adjustment.Conclusion Short-term follow-up suggests that tislelizumab shows a good trend in DFS benefits for adjuvant therapy after surgery in high-risk RCC patients, and adverse reactions are controllable. However, further confirmation is needed from longer-term, large-scale studies.
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表 1 26例患者临床特征及DFS率
% 项目 例数 百分比 DFS率(6个月) DFS率(≥12个月) P值 性别 0.492 男 18 69.23 100.00(18/18) 81.82(9/11) 女 8 30.77 100.00(8/8) 100.00(5/5) 年龄 0.512 < 65岁 16 61.54 100.00(16/16) 90.00(9/10) ≥65岁 10 38.46 100.00(10/10) 83.33(5/6) ECOG评分 0.503 0 21 80.77 100.00(21/21) 92.31(12/13) 1 5 19.23 100.00(5/5) 66.67(2/3) 原发肿瘤分期 0.487 T2 10 38.46 100.00(10/10) 100.00(6/6) T3 14 53.85 100.00(14/14) 87.50(7/8) T4 2 7.69 100.00(2/2) 50.00(1/2) Fuhrman核分级 0.517 1 1 3.85 100.00(1/1) 100.00(1/1) 2 14 53.85 100.00(14/14) 100.00(8/8) 3 9 34.61 100.00(9/9) 80.00(4/5) 4 2 7.69 100.00(2/2) 50.00(1/2) 伴肉瘤样改变 0.419 有 5 19.23 100.00(5/5) 100.00(3/3) 无(或未明确提示) 21 80.77 100.00(21/21) 84.62(11/13) 肾切除术方式 0.489 根治性肾切除 23 88.46 100.00(23/23) 85.71(12/14) 肾部分切除术 3 11.54 100.00(3/3) 100.00(2/2) CPS 0.398 < 1 6 23.08 100.00(6/6) 75.00(3/4) ≥1 16 61.54 100.00(16/16) 90.00(9/10) 未知 4 15.38 100.00(4/4) 100.00(2/2) 总计 26 100.00(26/26) 87.50(14/16) 
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表 2 本研究治疗相关不良反应发生率与KEYNOTE-564研究结果比较
% 不良反应 本研究组 KEYNOTE-564 Ⅲ期研究 1~2级 3~4级 1~2级 3~4级 乏力 23.08 0 19 1 瘙痒 19.23 0 18 < 1 甲状腺功能减退 15.39 0 17 < 1 皮疹 11.54 3.85 14 1 丙氨酸转氨酶升高 7.69 3.85 3 2 腹泻 7.69 3.85 14 2 天冬氨酸转氨酶升高 7.69 0 3 1 关节痛 7.69 0 9 < 1 发热 3.85 0 2 < 1 口干 3.85 0 4 < 1 斑丘疹 3.85 0 3 < 1 肌酸激酶升高 3.85 0 4 < 1 高血糖症 3.85 0 < 1 < 1 食欲下降 3.85 0 3 < 1 输注相关反应 3.85 0 < 1 < 1
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