摘要
目的 探讨高危非肌层浸润性膀胱癌患者行卡介苗(BCG)膀胱灌注的近期疗效和不良反应,以及影响疗效的因素。 方法 回顾性分析2014年3月至2017年12月收治的161例高危非肌层浸润性膀胱癌患者的资料,男121例(75.2%),女40例(24.8%)。中位年龄65岁(60~71)岁,其中<50岁17例(10.6%),50~59岁23例(14.3%),60~69岁72例(44.7%),≥70岁49例(30.4%)。初发患者112例(69.6%),复发患者49例(30.4%)。肿瘤单发56例(34.8%),多发105例(65.2%)。肿瘤直径≤3 cm 106例(65.8%),>3 cm 55例(34.2%)。43例(26.7%)伴原位癌。10例(6.2%)为尿路上皮癌伴变异类型。根据美国癌症联合会(AJCC)第7版TNM分期:Ta期25例(15.5%),T1期129例(80.1%),Tis期7例(4.3%)。低级别癌8例(5%),高级别癌153例(95%)。69例(42.9%)既往有灌注化疗史。161例均于TURBT术后采用BCG进行膀胱灌注治疗,其中未行二次电切术直接灌注者43例,二次电切术后灌注者118例。灌注方案为BCG 120 mg溶于生理盐水50 ml,灌注后保留2 h后排出体外。疗程为每周1次,共6次,然后每2周1次,共3次,然后每月1次共10次,总疗程持续1年。灌注期间,每3个月复查1次膀胱镜和尿脱落细胞学,每6~12个月复查1次腹、盆腔CT及胸部X线片。记录患者灌注后不良反应及随访数据,采用1年无复发生存率评估BCG灌注治疗的近期疗效。采用单因素和多因素回归分析预测膀胱癌患者BCG灌注治疗失败的危险因素。 结果 本组161例均获得随访,中位随访时间13个月(7~22)个月,总体复发率为26.1%(42/161),1年无复发生存率为79.0%。单因素回归分析结果显示BCG灌注失败与膀胱癌复发病史(P=0.006)、灌注化疗史(P=0.031)和灌注前二次电切史(P=0.007)有显著相关性。多因素回归分析结果显示膀胱癌复发病史是BCG灌注治疗失败的独立预测因素(P=0.020)。116例的不良反应发生率为40.4%(65/161),其中1级不良反应占53.8%(35/65),2级不良反应占40.0%(26/65),3级不良反应占6.2%(4/65)。因无法耐受不良反应,6例(3.7%)减量,1例(0.6%)停药。 结论 高危非肌层浸润性膀胱癌患者TURBT术后行BCG膀胱灌注治疗的近期疗效确切,不良反应小。膀胱癌复发病史是高危非肌层浸润性膀胱癌患者BCG灌注治疗失败的独立预测因素。
Objective To investigate the short-term efficacy, safety and factors affecting the efficacy of BCG intravesical therapy in high risk non-muscle-invasive bladder cancer (NMIBC) patients.Methods A total of 161 high-risk non-muscle invasive bladder cancer (NMIBC) patients were reviewed in our hospital from March 2014 to December 2017. They were all treated with BCG instillation after transurethral resection of bladder tumor (TURBT). There were 121 males (75.2%) and 40 females (24.8%). Median age was 65 years old, including 17 cases (10.6%) <50 years old, 23 cases (14.3%) within 50-59 years old, 72 cases (44.7%) within 60-69 years old, 49 cases ≥70 years old (30.4%). There were 112 patients (69.6%) with primary bladder cancer and 49 (30.4%) patients with recurrent bladder cancer. 56 cases (34.8%) had single tumor and 105 cases (65.2%) had multiple tumors. The tumors size in 106 cases (65.8%) was less than 3 cm, and tumor size in 55 cases (34.2%) was more than 3 cm. 43 patients (26.7%) suffered carcinoma in situ. 10 patients (6.2%) suffered urothelial carcinoma with variant types. According to the American Joint Commission for Cancer (AJCC) version 7 TNM staging system, 25 cases (15.5%) were classified into Ta stage, 129 cases (80.1%) were classified into T1 stage, and 7 cases (4.3%) were classified into Tis stage. There were 8 cases (5%) with low-grade cancer and 153 cases (95%) with high-grade cancer. 69 patients (42.9%) received chemo-instillation before. 43 cases were directly perfused without re-TURBT and 118 cases were perfused after re-TURBT. They were all treated with BCG instillation after transurethral resection of bladder tumor (TURBT). The 120 mg BCG were dissolved into 50 ml saline for instillation and were kept for 2 hours. Induction scheme of six-weekly and three fortnightly instillations started two weeks after the initial TUR or re-TUR. Maintenance instillations were then be offered in a scheme of ten monthly instillations. During treatment, patients were offered cystoscopy and cytology every three months, while CT and chest radiographs were reviewed every 6-12 months. Recurrence status and adverse effects were recorded. Univariate and multivariate regression analyses were performed to predict risk factors for failure of BCG instillation in bladder cancer.Results A total of 161 patients were followed up. The median follow-up time was 13 months, ranging 7-22 months. The overall recurrence rate was 26.1% (42/161) and the 1-year recurrence-free survival rate was 79.0%. On univariate analysis, recurrence history, history of instillation chemotherapy application and history of re-staging transurethral resection influenced recurrence. Multivariate regression analysis showed recurrence status was an independent prognostic factor regarding recurrence-free survival. The incidence of adverse events in all 161 instillation patients was 40.4% (26/65). Grade 1, grade 2 and grade 3 adverse events accounted for 53.8%(35/65), 40.0%(26/65) and 6.2%(4/65) respectively. 6 cases (3.7%) reduced the dose of BGC and 1 case stop the instillation due to the intolerance of BCG. Conclusion Short-term efficiency and safety were confirmed in BCG-treated high-risk NMIBC patients. And recurrence status was an independent prognostic factor for recurrence-free survival.
作者
徐佩行
陆骁霖
沈益君
马春光
朱一平
戴波
叶定伟
Xu Peihang;Lu Xiaolin;Shen Yijun;Ma Chunguang;Zhu Yiping;Dai Bo;Ye Dingwei(Department of Urology,Fudan University Shanghai Cancer Center,Department of Oncology ,Fudan University, Shanghai 200032,China)
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2019年第1期20-24,共5页
Chinese Journal of Urology
关键词
卡介苗
膀胱癌
膀胱灌注
Bacillus Calmette-Guérin
Bladder cancer
Intraversical instillation
