Yu Guang Tan, J Dudinec, A M Kamat, B J H Lim, A Ghoreifi, J S P Yuen, K Chen, R Kanesvaran, J Chan, A M Shah, K J Tay, M R Abern
{"title":"膀胱内注射吉西他滨/多西他赛治疗bcg无反应的非肌肉侵袭性膀胱癌的当代肿瘤学和患者报告的结果：一项多机构前瞻性队列研究","authors":"Yu Guang Tan, J Dudinec, A M Kamat, B J H Lim, A Ghoreifi, J S P Yuen, K Chen, R Kanesvaran, J Chan, A M Shah, K J Tay, M R Abern","doi":"10.1016/j.euf.2026.09.008","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To investigate the oncological and patient-reported outcomes (PROs) of patients receiving sequential gemcitabine/docetaxel (Gem/Doce) for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC).</p><p><strong>Design, setting, and participants: </strong>Patients enrolled in prospective databases at two academic medical institutions who received Gem/Doce -for BCG-unresponsive NMIBC between January 2021 and January 2026 were included. The primary outcome was the 3-mo and 12-mo high-grade recurrence-free survival (HGRFS). Secondary outcomes included progression-free survival (PFS), radical treatment-free survival (RTFS), cancer-specific survival (CSS) and overall survival (OS). Subgroup analyses compared BCG refractory versus early-relapsing and carcinoma in situ (CIS) ± papillary versus papillary-only disease. Adverse events were reported with the common terminology criteria for adverse events version 6.0. PRO assessments were performed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and NMIBC24 questionnaires.</p><p><strong>Results and limitations: </strong>Sixty-three patients were included. The median follow-up was 14 mo (interquartile range = 8-27). HGRFS rates at 3 and 12 mo were 88.8% (95% confidence interval [CI] = 81.3-97.0) and 68.1% (95% CI = 56.6-81.8), respectively. PFS at 12 mo was 90.1% (82.0-98.9%), RTFS 89.1% (80.5-98.7%), CSS 98.0% (94.3-100.0%), and OS 90.6% (80.9-100.0%). The BCG-refractory subgroup was associated with a higher risk of high-grade recurrence compared with early-relapsing (hazard ratio 2.44, 95% CI = 1.01-5.94, p = 0.048), whereas no difference was observed between CIS ± papillary and papillary-only subgroup (p = 0.20). Eight patients (12.7%) underwent radical cystectomy and six patients (9.5%) experienced disease progression. Twenty patients (31.7%) experienced mild irritative symptoms and no grade 3 or 4 adverse events were reported. Urinary symptom burden, global function, and functional outcomes remained stable during treatment.</p><p><strong>Conclusions: </strong>In this multi-institutional prospective study, intravesical Gem/Doce demonstrated favorable intermediate oncological outcomes for BCG-unresponsive NMIBC. Gem/Doce was well tolerated with few reported side effects and preserved PROs.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":6.3000,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Contemporary Oncological and Patient-reported Outcomes of Intravesical Gemcitabine/Docetaxel in BCG-unresponsive Non-muscle-invasive Bladder Cancer: A Multi-institutional Prospective Cohort Study.\",\"authors\":\"Yu Guang Tan, J Dudinec, A M Kamat, B J H Lim, A Ghoreifi, J S P Yuen, K Chen, R Kanesvaran, J Chan, A M Shah, K J Tay, M R Abern\",\"doi\":\"10.1016/j.euf.2026.09.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To investigate the oncological and patient-reported outcomes (PROs) of patients receiving sequential gemcitabine/docetaxel (Gem/Doce) for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC).</p><p><strong>Design, setting, and participants: </strong>Patients enrolled in prospective databases at two academic medical institutions who received Gem/Doce -for BCG-unresponsive NMIBC between January 2021 and January 2026 were included. The primary outcome was the 3-mo and 12-mo high-grade recurrence-free survival (HGRFS). Secondary outcomes included progression-free survival (PFS), radical treatment-free survival (RTFS), cancer-specific survival (CSS) and overall survival (OS). Subgroup analyses compared BCG refractory versus early-relapsing and carcinoma in situ (CIS) ± papillary versus papillary-only disease. Adverse events were reported with the common terminology criteria for adverse events version 6.0. PRO assessments were performed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and NMIBC24 questionnaires.</p><p><strong>Results and limitations: </strong>Sixty-three patients were included. The median follow-up was 14 mo (interquartile range = 8-27). HGRFS rates at 3 and 12 mo were 88.8% (95% confidence interval [CI] = 81.3-97.0) and 68.1% (95% CI = 56.6-81.8), respectively. PFS at 12 mo was 90.1% (82.0-98.9%), RTFS 89.1% (80.5-98.7%), CSS 98.0% (94.3-100.0%), and OS 90.6% (80.9-100.0%). The BCG-refractory subgroup was associated with a higher risk of high-grade recurrence compared with early-relapsing (hazard ratio 2.44, 95% CI = 1.01-5.94, p = 0.048), whereas no difference was observed between CIS ± papillary and papillary-only subgroup (p = 0.20). Eight patients (12.7%) underwent radical cystectomy and six patients (9.5%) experienced disease progression. Twenty patients (31.7%) experienced mild irritative symptoms and no grade 3 or 4 adverse events were reported. Urinary symptom burden, global function, and functional outcomes remained stable during treatment.</p><p><strong>Conclusions: </strong>In this multi-institutional prospective study, intravesical Gem/Doce demonstrated favorable intermediate oncological outcomes for BCG-unresponsive NMIBC. Gem/Doce was well tolerated with few reported side effects and preserved PROs.</p>\",\"PeriodicalId\":12160,\"journal\":{\"name\":\"European urology focus\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2026-10-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European urology focus\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.euf.2026.09.008\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology focus","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.euf.2026.09.008","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Contemporary Oncological and Patient-reported Outcomes of Intravesical Gemcitabine/Docetaxel in BCG-unresponsive Non-muscle-invasive Bladder Cancer: A Multi-institutional Prospective Cohort Study.
Objective: To investigate the oncological and patient-reported outcomes (PROs) of patients receiving sequential gemcitabine/docetaxel (Gem/Doce) for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC).
Design, setting, and participants: Patients enrolled in prospective databases at two academic medical institutions who received Gem/Doce -for BCG-unresponsive NMIBC between January 2021 and January 2026 were included. The primary outcome was the 3-mo and 12-mo high-grade recurrence-free survival (HGRFS). Secondary outcomes included progression-free survival (PFS), radical treatment-free survival (RTFS), cancer-specific survival (CSS) and overall survival (OS). Subgroup analyses compared BCG refractory versus early-relapsing and carcinoma in situ (CIS) ± papillary versus papillary-only disease. Adverse events were reported with the common terminology criteria for adverse events version 6.0. PRO assessments were performed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and NMIBC24 questionnaires.
Results and limitations: Sixty-three patients were included. The median follow-up was 14 mo (interquartile range = 8-27). HGRFS rates at 3 and 12 mo were 88.8% (95% confidence interval [CI] = 81.3-97.0) and 68.1% (95% CI = 56.6-81.8), respectively. PFS at 12 mo was 90.1% (82.0-98.9%), RTFS 89.1% (80.5-98.7%), CSS 98.0% (94.3-100.0%), and OS 90.6% (80.9-100.0%). The BCG-refractory subgroup was associated with a higher risk of high-grade recurrence compared with early-relapsing (hazard ratio 2.44, 95% CI = 1.01-5.94, p = 0.048), whereas no difference was observed between CIS ± papillary and papillary-only subgroup (p = 0.20). Eight patients (12.7%) underwent radical cystectomy and six patients (9.5%) experienced disease progression. Twenty patients (31.7%) experienced mild irritative symptoms and no grade 3 or 4 adverse events were reported. Urinary symptom burden, global function, and functional outcomes remained stable during treatment.
Conclusions: In this multi-institutional prospective study, intravesical Gem/Doce demonstrated favorable intermediate oncological outcomes for BCG-unresponsive NMIBC. Gem/Doce was well tolerated with few reported side effects and preserved PROs.
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
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