Safety and short-term efficacy of chemotherapy combined with PD-1 inhibitors in the treatment of metastatic bladder cancer
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摘要: 目的 评价化疗联合PD-1抑制剂治疗转移性膀胱癌的初步疗效及安全性。方法 回顾性分析2020年5月—2021年5月就诊于北京市朝阳区桓兴肿瘤医院行化疗联合PD-1抑制剂治疗的14例转移性膀胱癌患者的临床资料，病理均为尿路上皮癌。治疗方案为静脉滴注国产PD-1抑制剂(信迪利单抗200 mg、特瑞普利单抗240 mg、替雷利珠单抗200 mg)每3周1次，应用吉西他滨+顺铂(Cisplatin+Gemcitabine，GC)方案或顺铂不耐受时应用吉西他滨+卡铂或白蛋白紫杉醇+卡铂，分析客观缓解率、无进展生存期及不良反应。结果 14例患者中位年龄为64(46.0~82.0)岁，客观缓解率为57.14%(8/14)，疾病控制率为92.86%(13/14)。主要不良反应中转氨酶及胆红素升高1例(7.14%)，甲状腺功能减退症1例(7.14%)，甲状腺功能亢进1例(7.14%)，皮疹3例(21.43%)，胃肠道反应(恶心伴或不伴呕吐)3例(21.43%)，脱发1例(7.14%)，骨髓抑制2例(14.29%)，乏力1例(7.14%)，肾功能损伤1例(7.14%)。患者的不良反应主要为1~2级，3例发生3~4级不良反应，经对症治疗好转。结论 化疗联合PD-1抑制剂治疗转移性膀胱癌有较高的客观缓解率，尤其是GC方案联合PD-1抑制剂，且不良反应多可耐受，为临床抉择提供参考。Abstract: Objective To investigate the preliminary efficacy and safety of chemotherapy combined with PD-1 inhibitors in the treatment of metastatic bladder cancer.Methods The clinical data of 14 patients with metastatic bladder cancer who received chemotherapy combined with PD-1 inhibitor in Cancer Hospital of HuanXing Chaoyang District Beijing from May 2020 to May 2021 were retrospectively analyzed, all with uroepithelial carcinoma on pathology. All patients received infusion of domestic PD-1 inhibitors (200 mg Sintilimab, 240 mg Toripalimab or 200 mg Tislelizumab intravenously every 3 weeks, and gemcitabine + cisplatin (GC) regimen was applied or gemcitabine + carboplatin and albumin paclitaxel + carboplatin were applied when cisplatin was intolerant. The objective remission rate (ORR), progression-free survival (PFS), and adverse effects were analyzed.Results The median age was 64 (46.0-82.0) years, with an ORR of 57.14% (8/14) and disease control rate (DCR) of 92.86% (13/14) in 14 patients. The main adverse effects included elevated transaminases and bilirubin (n=1; 7.14%), hypothyroidism (n=1; 7.14%), hyperthyroidism (n=1; 7.14%), the rash (n=3; 21.43%), gastrointestinal reactions (nausea with or without vomiting) (n=3; 21.43%), hair loss (n=1; 7.14%), bone marrow suppression (n=2; 14.29%), fatigue (n=1; 7.14%) and renal impairment (n=1; 7.14%). Most adverse effects were of grade 1-2, and grade 3-4 adverse events occurred in three cases, which improved with symptomatic treatment.Conclusion Chemotherapy combined with PD-1 inhibitors in the treatment of metastatic bladder cancer has a high ORR, especially GC combined with PD-1 inhibitors, and most of the adverse reactions can be tolerated. It provides reference for clinical decision.
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Key words:
- PD-1 inhibitor /
- chemotherapy /
- metastatic bladder cancer
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表 1 患者不良反应情况
例 项目 分级 总发生率%(1~4级) 0 1 2 3 4 白细胞减少 13 0 0 0 1 7.14 中性粒细胞减少 13 0 0 0 1 7.14 血红蛋白减少 11 1 2 0 0 21.43 消化道反应 11 1 2 0 0 21.43 肝功能损伤 13 0 0 1 0 7.14 肾功能损伤 13 1 0 0 0 7.14 皮疹 11 2 1 0 0 21.43 脱发 12 2 0 0 0 14.29 乏力 13 1 0 0 0 7.14 甲状腺功能减退 13 1 0 0 0 7.14 甲状腺功能亢进 13 1 0 0 0 7.14 
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