Elsawy Amr A, Laymon Mahmoud, Mansour Islam, Elghareeb Ahmed, Harraz Ahmed
Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Arab J Urol. 2023 Mar 21;21(3):142-149. doi: 10.1080/2090598X.2023.2190687. eCollection 2023.
We lack tools to predict treatment and survival outcomes in patients receiving additional BCG therapy as a bladder-preserving therapy in high grade/T1, Tis NMIBC patients who showed persistent/recurrent tumors at three-month follow-up.
To assess the predictors of additional BCG response in patients who experienced persistent/recurrent tumors at three-month follow-up after BCG induction.
We retrospectively analyzed database for NMIBC. Between 2000 and 2019, 231 patients with high-grade T1/Tis NMIBC showed persistent/recurrent tumors at 3-month after BCG-induction, refused or were unfit to radical cystectomy (RC) and were offered additional intravesical BCG as bladder-preserving treatment. Predictors of the outcome after additional BCG were studied using univariate and multivariate logistic regression analysis. Kaplan Meier curve was utilized to estimate the recurrence-free survival (RFS) and progression-free survival (PFS). COX regression analysis was performed to identify independent predictors or RFS and PFS.
During a median (range) of 148 (24-224) months, poor response to additional BCG (tumor recurrence and/or progression) was noted in 112 (48.5%) patients. On multivariate logistic regression analysis, 3-month tumor features (persistent T stage, persistent grade and persistent/new CIS) significantly predicted poor response to additional BCG (OR: 3.4, 95%CI: 1.3-10.8, p = 0.021, OR: 2.1, 95%CI: 1.1-4.1, p = 0.02 and OR: 16.6, 95%CI: 4.5-109, =<0.001, respectively). The mean RFS was 26 (9-152) months with identified 3-month tumor features (persistent T stage and persistent/new CIS) as independent predictors of RFS (HR = 11.5, 95%CI = 2.7-48.3, p = 0.001 and HR = 2.5, 95%CI = 1.5-4.1, =<0.001, respectively) on multivariate COX regression analysis. In addition, 3-month tumor features (persistent/new CIS, non-papillary shape and bladder neck involvement) were identified to significantly predict PFS (HR = 6.2, 95%CI = 3.4-11.5, =<0.001 and HR = 2.3, 95%CI = 1.3-4.3 p = 0.001 and HR = 2.1, 95%CI = 1.2-3.8, =<0.005, respectively).
Three-month tumor features could be utilized as a tool to predict treatment outcomes and survival benefits when additional intravesical BCG is utilized as a bladder-preserving treatment in patients with recurrent/persistent tumors at three-month follow-up.
对于高级别/T1、Tis非肌层浸润性膀胱癌（NMIBC）患者，在三个月随访时出现持续性/复发性肿瘤，我们缺乏预测其接受额外卡介苗（BCG）治疗作为保膀胱治疗的疗效和生存结果的工具。
评估卡介苗诱导治疗后三个月随访时出现持续性/复发性肿瘤的患者对额外卡介苗治疗反应的预测因素。
我们对NMIBC数据库进行了回顾性分析。2000年至2019年期间，231例高级别T1/Tis NMIBC患者在卡介苗诱导治疗三个月后出现持续性/复发性肿瘤，拒绝或不适合行根治性膀胱切除术（RC），并接受了额外的膀胱内卡介苗作为保膀胱治疗。使用单因素和多因素逻辑回归分析研究额外卡介苗治疗后结局的预测因素。采用Kaplan-Meier曲线估计无复发生存期（RFS）和无进展生存期（PFS）。进行COX回归分析以确定RFS和PFS的独立预测因素。
在中位（范围）148（24 - 224）个月期间，112例（48.5%）患者对额外卡介苗治疗反应不佳（肿瘤复发和/或进展）。多因素逻辑回归分析显示，三个月时的肿瘤特征（持续性T分期、持续性分级和持续性/新发原位癌）显著预测了对额外卡介苗治疗的不良反应（比值比：3.4，95%置信区间：1.3 - 10.8，p = 0.021；比值比：2.1，95%置信区间：1.1 - 4.1，p = 0.02；比值比：16.6，95%置信区间：4.5 - 109，p < 0.001）。多因素COX回归分析显示，具有已确定的三个月时肿瘤特征（持续性T分期和持续性/新发原位癌）的患者，其平均RFS为26（9 - 152）个月，这些特征是RFS的独立预测因素（风险比：11.5，95%置信区间：2.7 - 4,8.3，p = 0.001；风险比：2.5，95%置信区间：1.5 - 4.1，p < 0.001）。此外，三个月时的肿瘤特征（持续性/新发原位癌、非乳头状形态和膀胱颈受累）被确定为PFS的显著预测因素（风险比：6.2，95%置信区间：3.4 - 11.5，p < 0.001；风险比：2.3，95%置信区间：1.3 - 4.3，p = 0.001；风险比：2.1，95%置信区间：1.2 - 3.8，p < 0.005）。
对于在三个月随访时出现复发性/持续性肿瘤的患者，当使用额外的膀胱内卡介苗作为保膀胱治疗时，三个月时的肿瘤特征可作为预测治疗结局和生存获益的工具。
