最近，针对卡介苗无反应（BCG-U）非肌层浸润性膀胱癌（NMIBC）的药物开发激增。迫切需要对这些药物进行严格评估，并提出最佳患者和治疗选择的实用建议，特别是在缺乏膀胱保留治疗 (BST) 方案的随机试验的情况下。一个由膀胱癌专家组成的全球委员会成立了，以制定有关 BST 的建议适用于 BCG-U NMIBC。工作组审查了文献并制定了建议草案，然后由国际膀胱癌小组 (IBCG) 成员使用修改后的德尔菲法进行投票。在2023年8月的现场会议上，提出了投票结果和支持证据，并根据会议讨论完善了建议。最终建议在会议期间达成了 75% 以上的共识，其中一些建议通过网络会议和电子邮件讨论进一步完善。对于寻求避免根治性膀胱切除术 (RC) 的 BCG-U 疾病患者，目前还没有单一的最佳药物。 BST 选择应个性化，考虑患者个体特征和偏好、肿瘤属性以及可用药物的功效/毒性数据。对于 BCG-U 原位癌 (CIS) 患者，推荐吉西他滨/多西他赛 (GEM/DOCE)、nadofaragene firadenovec (NFF) 和 nogapendekin alfa inbakicept-pmln (NAI) BCG；由于其全身毒性，派姆单抗只能在用尽其他选择后才可使用。对于仅患有 BCG-U 乳头状肿瘤的患者，建议使用 GEM/DOCE、NFF、NAI BCG、单药化疗、热丝裂霉素 C 和派姆单抗。鉴于可用选项的功效有限，鼓励参与临床试验。对于已报告数据的未经批准药物，IBCG 建议等待关键试验的最终结果。IBCG 共识建议为 BCG-U NMIBC 的 BST 提供实用指导。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

There has been a recent surge in the development of agents for bacillus Calmette-Guérin-unresponsive (BCG-U) non-muscle-invasive bladder cancer (NMIBC). Critical assessment of these agents and practical recommendations for optimal selection of patients and therapies are urgently needed, especially in the absence of randomized trials on bladder-sparing treatment (BST) options.A global committee of bladder cancer experts was assembled to develop recommendations on BST for BCG-U NMIBC. Working groups reviewed the literature and developed draft recommendations, which were then voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During a live meeting in August 2023, voting results and supporting evidence were presented, and recommendations were refined on the basis of meeting discussions. Final recommendations achieved >75% agreement during the meeting, and some were further refined via web conferences and e-mail discussions.There is currently no single optimal agent for patients with BCG-U disease who seek to avoid radical cystectomy (RC). BST selection should be personalized, taking into account individual patient characteristics and preferences, tumor attributes, and efficacy/toxicity data for the agents available. For patients with BCG-U carcinoma in situ (CIS), gemcitabine/docetaxel (GEM/DOCE), nadofaragene firadenovec (NFF), and nogapendekin alfa inbakicept-pmln (NAI) + BCG are recommended; because of its systemic toxicity, pembrolizumab should only be offered after other options are exhausted. For patients with BCG-U papillary-only tumors, GEM/DOCE, NFF, NAI + BCG, single-agent chemotherapy, hyperthermic mitomycin C, and pembrolizumab are recommended. Given the modest efficacy of available options, clinical trial participation is encouraged. For unapproved agents with reported data, IBCG recommendations await the final results of pivotal trials.The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.