拉丁美洲非肌层浸润性膀胱癌卡介苗使用情况的多中心回顾性登记研究：BLATAM（拉丁美洲膀胱癌）组
Multicenter Retrospective Registry Study on BCG Use in Non-Muscle Invasive Bladder Cancer in Latin America: BLATAM (Bladder Cancer in Latin America) Group.
作者信息
Villoldo Gustavo M, Gonzalez Matias Ignacio, Faune Alvaro Vidal, Molina Ricardo Castillejos, Montoya Fernando Meza, Salcedo José Gadu Campos, Vitagliano Gonzalo, Zampolli Hamilton, Lima Alcedir Raiser, Bengio Ruben, Camean Juan J, Alfieri Germán Ándres, Escalante Guido J P, Castro Ivan Edgar Bravo, Pita Hernando Rios, Escuder Juan, Covarrubias Francisco Rodriguez, Oliveira Maria Fernanda, Sanchez-Salas Rafael, Favre Gabriel Andrés, Guevara Eduardo, Videla Esteban Arismendi, Delgado Guillermo Martinez, Tobia Ignacio, Bachur Roberto F Villalba, Autran Ana Maria
机构信息
Instituto Alexander Fleming, Buenos Aires, Argentina.
Hospital Italiano, Buenos Aires, Argentina.
出版信息
Int Braz J Urol. 2025 May-Jun;51(3). doi: 10.1590/S1677-5538.IBJU.2024.0615.
OBJECTIVES
This study, conducted by the Bladder Cancer in Latin America (BLATAM) group, aims to analyze epidemiological and therapeutic data on non-muscle invasive bladder cancer (NMIBC) in Latin American patients. It seeks to identify factors contributing to suboptimal responses to Bacillus Calmette-Guérin (BCG) therapy and assess areas for improvement in regional treatment practices.
MATERIALS AND METHODS
A multicenter retrospective study was carried out in collaboration with reference Urology Departments across Latin America. Data were collected using an electronic Case Report Form (CRF) from 2011 to 2021, capturing demographics, clinical presentation, treatment details, and follow-up of NMIBC patients treated with BCG. Statistical analyses included Kaplan-Meier survival analysis for relapse-free survival (RFS).
RESULTS
Data from 292 patients across five countries were analyzed, with a mean age of 70.3 years and a male prevalence of 74%. Smoking history was reported in 70.6% of patients. The mean time to the first BCG dose was 2.4 months post-TURBT, with 26.7% of patients exceeding the recommended 60-day window for induction initiation. While 84% of patients completed BCG induction, only 45.9% followed the recommended Lamm maintenance schedule. Delays in starting maintenance cycles were observed, with a median delay of over 36 days for the first cycle and 65 days for the second cycle. RFS at 1 year and 5 years for high-risk patients was 87.3% and 53.3%, respectively.
CONCLUSIONS
This study highlights critical deviations from recommended NMIBC management protocols in Latin America, including delayed BCG initiation and inconsistencies in maintenance therapy. These findings emphasize the need for standardized treatment protocols and improved adherence to international guidelines, which could enhance NMIBC patient outcomes in the region. Collaborative efforts are essential to develop region-specific strategies, improve data collection, and ultimately provide better care for bladder cancer patients in Latin America.
目的
本研究由拉丁美洲膀胱癌（BLATAM）小组开展，旨在分析拉丁美洲患者非肌层浸润性膀胱癌（NMIBC）的流行病学和治疗数据。研究试图确定导致卡介苗（BCG）治疗反应欠佳的因素，并评估区域治疗实践中有待改进的方面。
材料与方法
与拉丁美洲各地的参考泌尿外科合作开展了一项多中心回顾性研究。使用电子病例报告表（CRF）收集2011年至2021年的数据，记录NMIBC患者的人口统计学信息、临床表现、治疗细节及随访情况。统计分析包括无复发生存期（RFS）的Kaplan-Meier生存分析。
结果
分析了来自五个国家共292例患者的数据，平均年龄为70.3岁，男性占比74%。70.6%的患者有吸烟史。首次BCG剂量的平均时间为经尿道膀胱肿瘤电切术（TURBT）后2.4个月，26.7%的患者超过了诱导起始推荐的60天窗口期。虽然84%的患者完成了BCG诱导，但只有45.9%的患者遵循了推荐的Lamm维持方案。观察到维持周期开始延迟，第一个周期的中位延迟超过36天，第二个周期为65天。高危患者1年和5年的无复发生存率分别为87.3%和53.3%。
结论
本研究突出了拉丁美洲在NMIBC管理方案方面与推荐方案的严重偏差，包括BCG起始延迟和维持治疗不一致。这些发现强调了制定标准化治疗方案以及更好地遵循国际指南的必要性，这可能改善该地区NMIBC患者的治疗结果。开展合作对于制定区域特定策略、改善数据收集并最终为拉丁美洲膀胱癌患者提供更好的护理至关重要。
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