Ostrowski David A, Chelluri Raju R, Herzig Matthew, Xia Leilei, Cortese Brian D, Roberson Daniel S, Guzzo Thomas J, Lee Daniel J, Malkowicz S Bruce
Division of Urology, Department of Surgery, University of Pennsylvania Health System, Philadelphia, PA 19104, USA.
Division of Urology and Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Cancers (Basel). 2023 Jul 24;15(14):3746. doi: 10.3390/cancers15143746.
The ongoing Bacillus Calmette-Guérin (BCG) shortage has created challenges for the treatment of non-muscle invasive bladder cancer (NMIBCa). Our objective was to evaluate the efficacy of reduced-dose induction BCG (RD-iBCG) compared to full-dose induction BCG (FD-iBCG) regarding recurrence rates. We hypothesized that patients receiving RD-iBCG may recur at a higher rate compared to those who received FD-iBCG therapy. A retrospective review of all patients with NMIBCa treated with intravesical therapy at our institution between 2015-2020 was conducted. Inclusion criteria consisted of having a diagnosis of AUA intermediate or high-risk NMIBCa with an indication for a six-week induction course of FD or RD-BCG with at least 1 year of documented follow up. The data were censored at one year. Propensity score matching for age, sex, tumor pathology, and initial vs. recurrent disease was performed. The primary endpoint was bladder cancer recurrence, reported as recurrence-free survival. A total of 254 patients were reviewed for this study. Our final cohort was 139 patients after exclusion. Thirty-nine percent of patients had HGT1 disease. 38.6% of patients receiving RD-BCG developed a recurrence of bladder cancer within a one-year follow-up as compared to 33.7% of patients receiving FD therapy. After propensity matching, this value remained statistically significant ( = 0.03). In conclusion, RD-iBCG for NMIBCa is associated with a significantly greater risk of recurrence than full-dose induction therapy, suggesting that RD-iBCG may not be equivalent or non-inferior to full-dose administration in the short term.
正在出现的卡介苗(BCG)短缺给非肌层浸润性膀胱癌(NMIBCa)的治疗带来了挑战。我们的目标是评估与全剂量诱导卡介苗(FD-iBCG)相比,低剂量诱导卡介苗(RD-iBCG)在复发率方面的疗效。我们假设接受RD-iBCG治疗的患者与接受FD-iBCG治疗的患者相比,复发率可能更高。我们对2015年至2020年期间在我们机构接受膀胱内治疗的所有NMIBCa患者进行了回顾性研究。纳入标准包括诊断为美国泌尿外科学会(AUA)中危或高危NMIBCa,有指征接受为期六周的FD或RD-BCG诱导疗程,并有至少1年的随访记录。数据在一年时进行截尾。对年龄、性别、肿瘤病理以及初发与复发疾病进行倾向评分匹配。主要终点是膀胱癌复发,以无复发生存率报告。本研究共纳入254例患者进行评估。排除后最终队列有139例患者。39%的患者患有HGT1疾病。在一年的随访中,接受RD-BCG治疗的患者中有38.6%出现膀胱癌复发,而接受FD治疗的患者中这一比例为33.7%。经过倾向评分匹配后,这一差异仍具有统计学意义(P = 0.03)。总之,NMIBCa患者使用RD-iBCG治疗的复发风险显著高于全剂量诱导治疗,这表明在短期内RD-iBCG可能与全剂量给药不等效或不劣于全剂量给药。