非肌层浸润性膀胱癌患者卡介苗膀胱灌注后不良反应对疗效的预测作用分析

Prediction value of adverse reactions after BCG for efficacy in patients with non-muscle-invasive bladder cancer

目的:探究非肌层浸润性膀胱癌(NMIBC)患者卡介苗(BCG)膀胱灌注后不良反应与疗效的关系。方法:回顾性分析2014年4月—2021年4月长海医院收治的141例接受BCG灌注的中、高危NMIBC患者的临床资料。中位随访时间22(1~64)个月,平均年龄(66.2±10.0)岁,中位年龄67(40~98)岁。所有患者均行经尿道膀胱肿瘤切除术(TURBT),术后进行规律BCG膀胱灌注。将单个不良反应进行单因素Cox回归分析,探究单个不良反应与疗效的关系。根据不良反应发生的分级、部位及数量的不同分别进行log-rank分析,探究不良反应不同亚组对疗效的预测作用。结果:121例(85.8%)患者出现BCG灌注相关不良反应。根据CTCAE 5.0标准分为1级不良反应65例和2级及以上不良反应76例,两组累计复发率分别为9.2%(6/65)和14.5%(11/76),差异无统计学意义(P=0.485)。进一步将不良反应分为无或局部不良反应62例和全身不良反应79例,两组累计复发率分别为9.7%(6/62)和13.9%(11/79),差异无统计学意义(P=0.575)。根据不良反应数量分为1种及以下不良反应47例、2种不良反应35例、3种及以上不良反应59例,三组累计复发率分别为14.9%(7/47)、11.4%(4/35)和10.2%(6/59),差异无统计学意义(P=0.705)。结论:BCG灌注引起不良反应的分级,部位及数量均与灌注疗效无显著关联。仍需前瞻性、大样本量研究以进一步明确BCG灌注后不良反应与其疗效的关系。

Objective:To investigate the relationship between adverse reactions and efficacy after bacillus calmette-guerin(BCG)in patients with non-muscle-invasive bladder cancer(NMIBC).Methods:The clinical data of 141 patients with middle or high risk NMIBC who received BCG intravesical instillation in Changhai Hospital from April 2014 to April 2021 were retrospectively analyzed.The median time of follow-up was 22(1-64)months.Patients’mean age was(66.2±10.0)years,and the median age was 67(40-98)years.All patients underwent transurethral resection of bladder tumor(TURBT),after which BCG instillation was performed regularly.Single adverse reactions were analyzed by univariate Cox regression analysis to explore the relationship between single adverse reaction and efficacy.Log-rank analysis was performed according to the grade,location and number of adverse reactions,respectively,to explore the predictive value of different subgroups of adverse reactions on efficacy.Results:BCG related adverse reactions were found in 121 patients(85.8%).According to CTCAE 5.0 standard,there were 65 cases of grade 1 adverse reactions and 76 cases of grade 2 or above.The cumulative recurrence rates of the two groups were 9.2%(6/65)and 14.5%(11/76),respectively,and the difference was not statistically significant(P=0.485).Adverse reactions were further divided into 62 cases with no or local adverse reactions and 79 cases with systemic adverse reactions.The cumulative recurrence rates of the two groups were 9.7%(6/62)and 13.9%(11/79),respectively,with no statistically significant difference(P=0.575).According to the number of adverse reactions,there were 47 cases of 1 type or less adverse reactions,35 cases of 2 type adverse reactions,and 59 cases of 3 type or more adverse reactions.The cumulative recurrence rates of the three groups were 14.9%(7/47),11.4%(4/35)and 10.2%(6/59),respectively,and the difference was not statistically significant(P=0.705).Conclusion:The grade,location and number of adverse effects after BCG intravesical instillation was not correlated with the efficacy of BCG treatment.Prospective,large sample size studies are needed to further clarify the relationship between BCG post-instillation adverse reactions and efficacy.