Khaled Obaid, Çağrı Akpınar, Murat Can Karaburun, Muhammed Arif İbiş, Çağatay Göğüş, Kadir Türkölmez, Sümer Baltacı, Evren Süer
{"title":"一项比较卡介苗RIVM和俄罗斯菌株治疗非肌肉浸润性膀胱癌的疗效和副作用的随机前瞻性试验。","authors":"Khaled Obaid, Çağrı Akpınar, Murat Can Karaburun, Muhammed Arif İbiş, Çağatay Göğüş, Kadir Türkölmez, Sümer Baltacı, Evren Süer","doi":"10.1016/j.urolonc.2025.08.028","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Intravesical Bacillus Calmette-Guérin (BCG) therapy is widely used as an adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). However, the optimal BCG substrain remains undetermined. This study compares the efficacy and safety of the BCG RIVM and Russian substrains in NMIBC treatment.</p><p><strong>Objective: </strong>To evaluate recurrence-free survival (RFS), progression-free survival (PFS), and adverse event profiles between the 2 substrains.</p><p><strong>Methods: </strong>In this randomized prospective trial, 149 patients with intermediate-, high-, and very high-risk NMIBC were randomized to receive either BCG RIVM or BCG Russian following transurethral resection of bladder tumor (TURBT). Patients with inadequate BCG therapy, short follow-up, or exposure to multiple strains were excluded from the per-protocol analysis (n = 125). Kaplan-Meier analysis was used to evaluate survival outcomes in both the per-protocol and intention-to-treat (ITT) populations. Adverse events were also assessed.</p><p><strong>Results: </strong>Of 125 patients, 61 received BCG RIVM and 64 received BCG Russian. Recurrence occurred in 17 (27.9%) and 19 (29.7%) patients in the RIVM and Russian groups, respectively (P = 0.822). The 48-month RFS rates were 72.1% (CI: 60.9-83.2) and 70.3% (CI: 59.2-81.4). Progression occurred in 4 patients (6.6%) vs. 8 patients (12.5%) in the RIVM and Russian groups, respectively (P = 0.365). The 48-month PFS rates were 93.4% (CI: 87.2-99.6) and 87.5% (CI: 79.4-96.9). Kaplan-Meier curves for RFS and PFS indicated no significant difference between the 2 groups (log-rank P = 0.875 for RFS and 0.267 for PFS). Similar findings were observed in the ITT analysis (log-rank P = 0.791 for RFS and 0.419 for PFS). Adverse events were reported in 76% of patients, with no significant differences between the groups in terms of toxicity (P = 0.545).</p><p><strong>Conclusions: </strong>BCG RIVM and Russian substrains demonstrated comparable efficacy and safety, supporting substrain selection based on availability and institutional preference.</p>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomized prospective trial comparing Bacillus Calmette-Guérin (BCG) RIVM and Russian strains in non-muscle invasive bladder cancer: Efficacy and side effects.\",\"authors\":\"Khaled Obaid, Çağrı Akpınar, Murat Can Karaburun, Muhammed Arif İbiş, Çağatay Göğüş, Kadir Türkölmez, Sümer Baltacı, Evren Süer\",\"doi\":\"10.1016/j.urolonc.2025.08.028\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Intravesical Bacillus Calmette-Guérin (BCG) therapy is widely used as an adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). 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Recurrence occurred in 17 (27.9%) and 19 (29.7%) patients in the RIVM and Russian groups, respectively (P = 0.822). The 48-month RFS rates were 72.1% (CI: 60.9-83.2) and 70.3% (CI: 59.2-81.4). Progression occurred in 4 patients (6.6%) vs. 8 patients (12.5%) in the RIVM and Russian groups, respectively (P = 0.365). The 48-month PFS rates were 93.4% (CI: 87.2-99.6) and 87.5% (CI: 79.4-96.9). Kaplan-Meier curves for RFS and PFS indicated no significant difference between the 2 groups (log-rank P = 0.875 for RFS and 0.267 for PFS). Similar findings were observed in the ITT analysis (log-rank P = 0.791 for RFS and 0.419 for PFS). 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引用次数: 0
摘要
背景：膀胱内卡介苗（BCG）治疗被广泛用于非肌肉浸润性膀胱癌（NMIBC）的辅助治疗。然而，最佳卡介苗亚株仍未确定。本研究比较了卡介苗RIVM和俄罗斯亚株治疗NMIBC的有效性和安全性。目的：评估两种亚型之间的无复发生存期（RFS）、无进展生存期（PFS）和不良事件概况。方法：在这项随机前瞻性试验中，149例中、高、高危NMIBC患者在经尿道膀胱肿瘤切除术（TURBT）后随机接受BCG RIVM或BCG Russian治疗。卡介苗治疗不足、随访时间短或暴露于多种菌株的患者被排除在按方案分析之外（n = 125）。Kaplan-Meier分析用于评估每个方案和意向治疗（ITT）人群的生存结果。对不良事件也进行了评估。结果：125例患者中，61例接受RIVM卡介苗治疗，64例接受Russian卡介苗治疗。RIVM组复发17例（27.9%），俄罗斯组复发19例（29.7%）（P = 0.822）。48个月RFS率分别为72.1% （CI: 60.9 ~ 83.2）和70.3% （CI: 59.2 ~ 81.4）。RIVM组和Russian组分别有4例（6.6%）和8例（12.5%）出现进展（P = 0.365）。48个月PFS率分别为93.4% （CI: 87.2-99.6）和87.5% （CI: 79.4-96.9）。RFS和PFS的Kaplan-Meier曲线显示两组间无显著差异（RFS的log-rank P = 0.875， PFS的log-rank P = 0.267）。ITT分析中也观察到类似的结果（RFS的log-rank P = 0.791， PFS的log-rank P = 0.419）。76%的患者报告了不良事件，两组在毒性方面无显著差异（P = 0.545）。结论：卡介苗RIVM和俄罗斯亚株的疗效和安全性相当，支持基于可获得性和机构偏好的亚株选择。
A randomized prospective trial comparing Bacillus Calmette-Guérin (BCG) RIVM and Russian strains in non-muscle invasive bladder cancer: Efficacy and side effects.
Background: Intravesical Bacillus Calmette-Guérin (BCG) therapy is widely used as an adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). However, the optimal BCG substrain remains undetermined. This study compares the efficacy and safety of the BCG RIVM and Russian substrains in NMIBC treatment.
Objective: To evaluate recurrence-free survival (RFS), progression-free survival (PFS), and adverse event profiles between the 2 substrains.
Methods: In this randomized prospective trial, 149 patients with intermediate-, high-, and very high-risk NMIBC were randomized to receive either BCG RIVM or BCG Russian following transurethral resection of bladder tumor (TURBT). Patients with inadequate BCG therapy, short follow-up, or exposure to multiple strains were excluded from the per-protocol analysis (n = 125). Kaplan-Meier analysis was used to evaluate survival outcomes in both the per-protocol and intention-to-treat (ITT) populations. Adverse events were also assessed.
Results: Of 125 patients, 61 received BCG RIVM and 64 received BCG Russian. Recurrence occurred in 17 (27.9%) and 19 (29.7%) patients in the RIVM and Russian groups, respectively (P = 0.822). The 48-month RFS rates were 72.1% (CI: 60.9-83.2) and 70.3% (CI: 59.2-81.4). Progression occurred in 4 patients (6.6%) vs. 8 patients (12.5%) in the RIVM and Russian groups, respectively (P = 0.365). The 48-month PFS rates were 93.4% (CI: 87.2-99.6) and 87.5% (CI: 79.4-96.9). Kaplan-Meier curves for RFS and PFS indicated no significant difference between the 2 groups (log-rank P = 0.875 for RFS and 0.267 for PFS). Similar findings were observed in the ITT analysis (log-rank P = 0.791 for RFS and 0.419 for PFS). Adverse events were reported in 76% of patients, with no significant differences between the groups in terms of toxicity (P = 0.545).
Conclusions: BCG RIVM and Russian substrains demonstrated comparable efficacy and safety, supporting substrain selection based on availability and institutional preference.
期刊介绍：
Urologic Oncology: Seminars and Original Investigations is the official journal of the Society of Urologic Oncology. The journal publishes practical, timely, and relevant clinical and basic science research articles which address any aspect of urologic oncology. Each issue comprises original research, news and topics, survey articles providing short commentaries on other important articles in the urologic oncology literature, and reviews including an in-depth Seminar examining a specific clinical dilemma. The journal periodically publishes supplement issues devoted to areas of current interest to the urologic oncology community. Articles published are of interest to researchers and the clinicians involved in the practice of urologic oncology including urologists, oncologists, and radiologists.
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