Use of Rectal Diazepam to Prevent Bladder Spasms and Leakage of Medication During Intravesical Administration of Nadofaragene Firadenovec for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer.

Jacob A Moyer,Adri M Durant,Mimi V Nguyen,Lanyu Mi,Andrew J Zganjar,Timothy D Lyon,Paras H Shah,Stephen A Boorjian,Mark D Tyson
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Abstract

PURPOSE Nadofaragene firadenovec-vncg is an FDA-approved therapy for bacille Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). Bladder spasms and medication leakage during intravesical instillation are common and can affect treatment efficacy. We evaluated the effect of rectal diazepam pretreatment on bladder spasm incidence, retention of instilled medication, and 3-month recurrence rates. MATERIALS AND METHODS We retrospectively analyzed data from patients treated with nadofaragene firadenovec for BCG-unresponsive NMIBC at Mayo Clinic from November 28, 2023, through September 30, 2024. Patients were stratified by pretreatment with rectal diazepam (10 mg) vs other strategies. Outcomes included bladder spasms, retention of instilled medication, and 3-month recurrence rates. RESULTS Eighty-eight nadofaragene firadenovec instillations (45 patients) were evaluated. Rectal diazepam pretreatment was used for 25 instillations (28%) and associated with a 25% absolute risk reduction for nadofaragene firadenovec retention failure (4.0% vs 29% of instillations), as compared with other pretreatments (patient-level odds ratio, 0.22 [95% CI, 0.11-0.44]; P<.001). Additionally, we observed a 24% absolute reduction in bladder spasm incidence (32% vs 56% of instillations) in the rectal diazepam group (patient-level odds ratio, 0.32 [95% CI, 0.13-0.82]; P=.02). Patients without medication leakage had a lower recurrence rate at 3 months (18% vs 38%), although this difference was not statistically significant (P=.3). One patient had fatigue attributable to rectal diazepam. CONCLUSIONS Rectal diazepam pretreatment may reduce bladder spasms and improve nadofaragene firadenovec retention during intravesical instillation, thereby enhancing efficacy. Rectal diazepam could improve patient comfort and treatment outcomes, thus warranting further investigation through larger, prospective studies.
应用直肠安定预防膀胱痉挛和膀胱内给药纳伐拉真非肌侵性膀胱癌时药物泄漏。
enadofaragene firadenovec-vncg是一种fda批准的治疗卡介苗(BCG)无反应的非肌肉侵袭性膀胱癌(NMIBC)的药物。膀胱痉挛和药物渗漏在膀胱内滴注过程中是常见的,并可影响治疗效果。我们评估了直肠地西泮预处理对膀胱痉挛发生率、输注药物潴留和3个月复发率的影响。材料与方法:我们回顾性分析了2023年11月28日至2024年9月30日在梅奥诊所接受纳faragene firadenovec治疗bcg无反应的NMIBC患者的数据。采用直肠用地西泮(10mg)和其他方法对患者进行分层。结果包括膀胱痉挛、输注药物潴留和3个月复发率。结果共对45例患者进行纳法拉吉芬腺苷滴注。直肠地西泮预处理25次(28%),与其他预处理相比,nadofaragene firadenovec留置失败的绝对风险降低25% (4.0% vs 29%)(患者水平优势比为0.22 [95% CI, 0.11-0.44];P <措施)。此外,我们观察到直肠注射地西泮组膀胱痉挛发生率绝对降低24% (32% vs 56%)(患者水平优势比0.32 [95% CI, 0.13-0.82];P = .02点)。无漏药的患者3个月复发率较低(18% vs 38%),但差异无统计学意义(P=.3)。1例患者因直肠安定引起疲劳。结论经直肠地西泮预处理可减少膀胱痉挛,改善纳法拉根膀胱内留置,从而提高疗效。直肠安定可以改善患者的舒适度和治疗效果,因此需要通过更大规模的前瞻性研究进行进一步的研究。
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