Scilipoti Pietro, Longoni Mattia, de Angelis Mario, Zaurito Paolo, Massiet Albane, Dutto Daniele, Soria Francesco, Álvarez-Maestro Mario, Bazán Alfredo Aguilera, Pradere Benjamin, Klatte Tobias, Contieri Roberto, Hurle Rodolfo, Krajewski Wojciech, Subiela José Daniel, Pichler Renate, Szostek Aleksandra, Marcq Gautier, Elena José Luis Rodríguez, Aranda Javier, Gontero Paolo, Rouprêt Morgan, Shariat Shahrokh F, Necchi Andrea, Montorsi Francesco, Briganti Alberto, Xylinas Evanguelos, Moschini Marco
Division of Experimental Oncology/Unit of Urology, IRCCS Ospedale San Raffaele, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
BJU Int. 2025 Jun;135(6):969-976. doi: 10.1111/bju.16645. Epub 2025 Jan 11.
To evaluate the oncological efficacy and safety of sequential intravesical gemcitabine/docetaxel (Gem/Doce) therapy in a European cohort of patients with high-risk and very-high-risk non-muscle-invasive bladder cancer (NMIBC) after previous Bacillus Calmette-Guérin (BCG) treatment.
Data were retrospectively collected from 95 patients with NMIBC, treated with Gem/Doce at 12 European centres between 2021 and 2024. Patients previously treated with BCG who had completed a full induction course and received at least one follow-up evaluation were included. One-year disease-free survival (DFS), high-grade DFS and progression-free survival (PFS) were estimated using Kaplan-Meier curves. Adverse events (AEs) were recorded through medical interviews.
Of 75 patients, 63 (84%) were classified as having high-risk and 12 (16%) as having very-high-risk NMIBC. Over a median (interquartile range) follow-up of 9 (5-14) months, 20 patients (27%) relapsed and five (6.7%) underwent radical cystectomy. The 1-year DFS was 73% (95% confidence interval [CI] 62-86%), 1-year high-grade DFS was 79% (95% CI 68-91%) and 1-year PFS was 95% (95% CI 90-100%). AEs occurred in 34 patients (45%), with six (8.7%) experiencing severe AEs. Limitations of the study include the short follow-up and variability in both treatment dwelling times and dosage across centres.
The intravesical Gem/Doce regimen demonstrated promising short-term oncological outcomes and was well tolerated in this cohort of patients with high- and very-high-risk NMIBC previously treated with BCG. Prospective studies and randomised trials are awaited to define the ideal candidates for Gem/Doce therapy and to standardise treatment protocols.
评估序贯膀胱内注射吉西他滨/多西他赛（Gem/Doce）疗法在欧洲一组既往接受过卡介苗（BCG）治疗的高危和极高危非肌层浸润性膀胱癌（NMIBC）患者中的肿瘤学疗效和安全性。
回顾性收集了2021年至2024年间在12个欧洲中心接受Gem/Doce治疗的95例NMIBC患者的数据。纳入既往接受过BCG治疗且已完成完整诱导疗程并接受至少一次随访评估的患者。使用Kaplan-Meier曲线估计1年无病生存期（DFS）、高级别DFS和无进展生存期（PFS）。通过医学访谈记录不良事件（AE）。
75例患者中，63例（84%）被分类为高危NMIBC，12例（16%）为极高危NMIBC。在中位（四分位间距）9（5 - 14）个月的随访期内，20例患者（27%）复发，5例（6.7%）接受了根治性膀胱切除术。1年DFS为73%（95%置信区间[CI] 62 - 86%），1年高级别DFS为79%（95% CI 68 - 91%），1年PFS为95%（95% CI 90 - 100%）。34例患者（45%）发生AE，6例（8.7%）经历严重AE。该研究的局限性包括随访时间短以及各中心治疗停留时间和剂量的变异性。
膀胱内Gem/Doce方案在这组既往接受过BCG治疗的高危和极高危NMIBC患者中显示出有前景的短期肿瘤学结果，且耐受性良好。有待进行前瞻性研究和随机试验以确定Gem/Doce疗法的理想候选者并规范治疗方案。
