Valentina Grajales, Roberto Contieri, Wei Shen Tan, Marta Flores, Marcela Schultz, Rodrigo Pinochet, Alberto Bustamante, Ashish M. Kamat, Mario I. Fernández
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Abstract
BACKGROUND:
Adjuvant bacillus Calmette-Guérin (BCG) is recommended for high-risk (HR) non-muscle invasive bladder cancer (NMIBC), but BCG shortages have led to exploration of reduced-dose regimens and shortened maintenance durations out of necessity, with limited data on treatment efficacy in Latin America.
OBJECTIVE:
Oncological outcomes of HR-NMIBC patients treated with reduced (RD,1/4th dose) vs full dose (FD) BCG instillations of Danish Strain 1331 BCG.
METHODS:
We performed a retrospective study of HR-NMIBC patients treated with BCG between 2003 and 2022 at our center in Santiago Chile. We stratified patients according to either RD (1/4th dose) or FD BCG. Univariate and multivariable Cox regression models were used to predict recurrence. Kaplan-Meier method was used to calculate survival estimates.
RESULTS:
Of a total of 200 patients, 116 (58%) had RD and 84 (42%) FD BCG. Median follow-up was 57 months (IQR: 29–100). Patients who received FD BCG had a lower risk of recurrence (HR: 0.41, 95% CI 0.22–0.74) and high-grade (HG)-recurrence (HR: 0.30, 95% CI 0.15–0.61; p = 0.001). More patients in the RD vs FD group progressed to MIBC (10/84 vs 2/116; p = 0.18). Additionally, patients were less likely to stop BCG treatment in the RD group compared to the FD group due to toxicity (5% vs 11%, p = 0.14).
CONCLUSIONS:
A 1/4th dose of Danish Strain 1331 BCG treatment was associated with worse recurrence free rate and HG-recurrence rate in our cohort. Patients with RD had lower discontinuation treatment rates due to a reduced toxicity profile. These findings would suggest that RD BCG would compromise oncological outcomes in HR-NMIBC patients.
背景:佐剂卡介苗(BCG)被推荐用于高风险(HR)非肌肉浸润性膀胱癌(NMIBC)，但由于卡介苗的短缺，不得不探索减少剂量的方案和缩短维持时间，在拉丁美洲的治疗效果数据有限。目的:减少(RD,1/4剂量)与全剂量(FD)灌注丹麦株1331卡介苗治疗HR-NMIBC患者的肿瘤预后。方法:我们在智利圣地亚哥的中心对2003年至2022年间接受卡介苗治疗的HR-NMIBC患者进行了回顾性研究。我们根据RD(1/4剂量)或FD BCG对患者进行分层。单变量和多变量Cox回归模型用于预测复发率。采用Kaplan-Meier法计算生存估计。结果:在总共200例患者中，116例(58%)患有RD, 84例(42%)患有FD BCG。中位随访57个月(IQR: 29-100)。接受FD卡介苗的患者有较低的复发风险(HR: 0.41, 95% CI 0.22-0.74)和高级别(HG)复发风险(HR: 0.30, 95% CI 0.15-0.61;p = 0.001)。RD组与FD组中更多的患者进展为MIBC (10/84 vs 2/116;p = 0.18)。此外，与FD组相比，RD组患者由于毒性而停止BCG治疗的可能性更小(5% vs 11%， p = 0.14)。结论:在我们的队列中，1/4剂量的丹麦1331株卡介苗治疗与较差的无复发率和hg复发率相关。由于毒性降低，RD患者的停药率较低。这些发现表明RD卡介苗会损害HR-NMIBC患者的肿瘤预后。
期刊介绍：
Bladder Cancer is an international multidisciplinary journal to facilitate progress in understanding the epidemiology/etiology, genetics, molecular correlates, pathogenesis, pharmacology, ethics, patient advocacy and survivorship, diagnosis and treatment of tumors of the bladder and upper urinary tract. The journal publishes research reports, reviews, short communications, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research in basic science, translational research and clinical medicine that expedites our fundamental understanding and improves treatment of tumors of the bladder and upper urinary tract.
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