Abstract:

Objective　To observe the efficacy and safety of neoadjuvant therapy[gemcitabine + cisplatin (GC) neoadjuvant chemotherapy combined with Tislelizumab immunotherapy] combined with radical cystectomy in the treatment of myometrial invasive bladder cancer (MIBC). Methods　A total of 6 MIBC patients who received neoadjuvant therapy combined with radical cystectomy in the First Affiliated Hospital of Gannan Medical University from June 2021 to January 2023 were selected as the study objects. All 6 cases were male; the age ranged from 53 to 70 years, with a median age of 62 years old; the clinical stage of tumor was T2N0M0 in 3 cases and T3N0M0 in 3 cases. Tislelizumab 200 mg was given intravenously on the 1st day, intravenous drip with 1 000 mg/m² of gemcitabine on the 1st and 8th day, and 70 mg/m² of cisplatin was given intravenously for 1-2 days, with 21 days as a course of treatment, a total of 3-4 courses. Within 6 weeks after neoadjuvant therapy, the patients underwent radical cystectomy and lymph node dissection. Clinical data, including age, smoking history, pathological grade, clinical stage, and incidence, were collected by electronic medical record system. The effect of neoadjuvant therapy was evaluated, including complete response, partial response, stable disease, and progression of disease. During neoadjuvant therapy, the occurrence of adverse reactions (grade 0 to 4) was recorded. The completion of radical cystectomy and lymph node dissection and the number of postoperative pathological downgrades were recorded. The patients were followed up for 8 to 26 months, and the recurrence of tumor was recorded. Fisher exact probability method was used for statistical analysis. Results　All the 6 patients with MIBC completed neoadjuvant therapy, with complete remission in 1 case (16.67%), partial remission in 2 cases (33.33%), stable disease in 3 cases (50.00%), an objective remission rate of 50.00% (3/6), and a disease control rate of 100.00% (6/6). There were no statistically significant differences in the clinical data between effective and ineffective MIBC patients (all P>0.05). During neoadjuvant therapy, the total incidence of adverse reactions was 100.00% (6/6), including 2 cases of grade 3-4 leukopenia, 1 case of grade 3-4 nausea and vomiting, and 1 case of grade 3-4 thrombocytopenia. All the 6 patients with MIBC underwent radical cystectomy plus lymph node dissection, and 1 patient had postoperative pathological decline (<pT2N0M0). None of the patients had tumor recurrence. Conclusion　Neoadjuvant therapy combined with radical cystectomy is effective and safe in the treatment of MIBC.

Key words:

Myometrial invasive bladder cancer, Neoadjuvant therapy, Radical cystectomy, Efficacy

摘要：

目的　观察新辅助治疗［吉西他滨+顺铂（GC）方案新辅助化疗+替雷利珠单抗免疫治疗］联合根治性膀胱切除术治疗肌层浸润性膀胱癌（MIBC）的效果。方法　选取2021年6月至2023年1月在赣南医科大学第一附属医院接受新辅助治疗联合根治性膀胱切除术治疗的6例MIBC患者作为研究对象。6例均为男性；年龄53～70岁，中位年龄62岁；肿瘤临床分期：T2N0M0 3例，T3N0M0 3例。第1天给予替雷利珠单抗注射液200 mg，静脉滴注；第1和第8天给予注射用盐酸吉西他滨1 000 mg/m²，静脉滴注；给予注射用顺铂70 mg/m²，分1～2 d静脉滴注；21 d为1个疗程，共3～4个疗程。新辅助治疗后6周内，完成根治性膀胱切除术（包括淋巴结清扫术）。采用电子病历系统收集患者临床资料，包括年龄、吸烟史、病理分级、临床分期和发病次数等。评估患者新辅助治疗效果，包括完全缓解、部分缓解、疾病稳定、疾病进展。新辅助治疗期间，记录患者不良反应发生情况（0～4级）。记录患者根治性膀胱切除术完成情况，以及术后病理降期例数。术后随访8～26个月，记录患者肿瘤复发情况。采用Fisher确切概率法进行统计学分析。结果　6例MIBC患者均完成新辅助治疗，完全缓解1例（16.67%），部分缓解2例（33.33%），疾病稳定3例（50.00%），客观缓解率为50.00%（3/6），疾病控制率为100.00%（6/6）。治疗有效与无效MIBC患者临床资料比较，差异均无统计学意义（均P>0.05）。新辅助治疗期间，不良反应总发生率为100.00%（6/6），其中3～4级白细胞减少2例、3～4级恶心呕吐1例、3～4级血小板减少1例。6例MIBC患者均完成根治性膀胱切除术，术后病理降期1例（<pT2N0M0）。术后随访8～26个月，所有患者均未出现肿瘤复发。结论　新辅助治疗联合根治性膀胱切除术治疗MIBC效果良好，安全性较高。

关键词:

肌层浸润性膀胱癌, 新辅助治疗, 根治性膀胱切除术, 治疗效果