卡介苗联合PANVAC™与单独卡介苗治疗成人高级别卡介苗难治性非肌肉侵袭性膀胱癌的比较

IF 2.3 3区医学 Q3 ONCOLOGY

Urologic Oncology-seminars and Original Investigations Pub Date : 2025-08-07 DOI:10.1016/j.urolonc.2025.06.006

Matthew Ho M.D. , Alon Lazarovich M.D., M.B.A. , Ragheed Saoud M.D. , Aaron Dahmen M.D. , Samuel Tremblay M.D. , Siobhan Telfer M.D. , Mahir Maruf M.D. , Eric A. Singer M.D., M.A., M.S. , Robert E. Weiss M.D. , Thomas L. Jang M.D., M.P.H. , Sammy E. Elsamra M.D. , Maria Merino M.D. , Rebecca Dolan CRNP, MN , Vladimir Valera M.D. , Beatriz Walter Rodriquez M.D., Ph.D. , Reema Railkar Ph.D. , Sonia Bellfield R.N., M.S.N. , Lambros Stamatakis M.D. , Joanna Shih Ph.D. , Renee N. Donahue Ph.D. , Piyush K. Agarwal M.D.

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引用次数: 0

摘要

目的：我们假设重组痘病毒载体疫苗PANVAC™可以增强复发性高级别非肌侵性膀胱癌（NMIBC）患者对卡介苗（BCG）附加诱导病程的免疫和临床应答。方法：这是一项随机、开放标签、前瞻性的II期研究，研究对象是至少1个膀胱内卡介苗诱导疗程失败的高级别NMIBC患者。患者随机分为卡介苗单药组和卡介苗+PANVAC组。所有受试者均接受膀胱内BCG治疗6周。联合组的患者也接受了启动和加强剂量的PANVAC。主要终点是无复发生存期。次要终点包括无进展生存期和无根治性膀胱切除术生存期。我们还评估了探索性次级免疫应答终点。结果：本研究基于预先计划的无效分析得出结论。总的来说，32名患者入组；2退出。分析了30例患者（15例/组）；卡介苗单用组5例（33.3%），卡介苗+PANVAC组5例（33.3%）符合卡介苗无反应性疾病标准。BCG单独组的12个月无复发生存率为53.3%，BCG+PANVAC组为40%。任何时间点的总复发率为73.3%，中位时间为10.8个月，其中BCG单独治疗组的总复发率为66.7%，BCG+PANVAC治疗组的总复发率为80%。中位无复发生存期和无进展生存期没有差异。结论：这项II期研究表明，在膀胱内卡介苗无效的NMIBC患者中，与单独使用卡介苗相比，卡介苗+PANVAC无复发生存期没有改善。

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Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer

Purpose

We postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC).

Methods

This was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints.

Results

Our study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival.

Conclusions

This phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

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来源期刊

Urologic Oncology-seminars and Original Investigations 医学-泌尿学与肾脏学

CiteScore

4.80

自引率

3.70%

发文量

297

审稿时长

7.6 weeks

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.