Olga M Pijpers, Sarianne G Bosch, Danielle C van Diepen, Joni Y Zee, Arnout R Alberts, Tahlita C M Zuiverloon, Kim E M van Kessel, Joost L Boormans
{"title":"Intravesical gemcitabine and docetaxel in patients with recurrent high-grade nonmuscle invasive bladder cancer-A prospective cohort study.","authors":"Olga M Pijpers, Sarianne G Bosch, Danielle C van Diepen, Joni Y Zee, Arnout R Alberts, Tahlita C M Zuiverloon, Kim E M van Kessel, Joost L Boormans","doi":"10.1016/j.urolonc.2025.03.024","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Intravesical instillations with gemcitabine and docetaxel (gem/doce) is an alternative treatment option in patients with nonmuscle invasive bladder cancer (NMIBC) in whom Bacillus Calmette-Guerin (BCG) failed or is contraindicated. However, prospective data on the efficacy is lacking. This study prospectively evaluated the efficacy and safety of intravesical gem/doce.</p><p><strong>Methods: </strong>This single-arm, prospective, observational study included patients with recurrent high-grade (HG) NMIBC who received intravesical gem/doce. Treatment involved 6 weekly instillations (induction), followed by monthly instillations for 1 year (maintenance). Follow-up included cystoscopy every 3 months. Histological confirmation of intravesical recurrences was mandatory. The efficacy evaluation was assessed among 37 patients who received at least 4 instillations and had at least 1 cystoscopic evaluation. Primary outcome was HG disease-free survival, defined as time to histologically confirmed HG recurrence, and/or radiologically confirmed lymph node involvement, or distant metastasis. Adverse events were assessed.</p><p><strong>Key findings and limitations: </strong>Thirty-nine patients with NMIBC were enrolled of whom 31 (79%) had Carcinoma in situ. Gem/doce was provided as third-line treatment in 87% (34/39) of the patients. Thirty-five patients had received BCG of whom 72% (28/39) were BCG-unresponsive. The median follow-up for patients without HG recurrence was 14 months (IQR: 7-25). The overall 1-year HG disease-free survival was 67% (95% CI: 53-85), and 73% (57-94) in patients with BCG-unresponsive NMIBC. Only one serious adverse event (grade 3) occurred. A limitation was the small sample size.</p><p><strong>Conclusions and clinical implications: </strong>In patients with recurrent HG NMIBC who are unfit or reluctant to undergo radical cystectomy and in whom BCG failed, intravesical gem/doce was effective and safe.</p>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":" ","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Urologic Oncology-seminars and Original Investigations","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.urolonc.2025.03.024","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background and objective: Intravesical instillations with gemcitabine and docetaxel (gem/doce) is an alternative treatment option in patients with nonmuscle invasive bladder cancer (NMIBC) in whom Bacillus Calmette-Guerin (BCG) failed or is contraindicated. However, prospective data on the efficacy is lacking. This study prospectively evaluated the efficacy and safety of intravesical gem/doce.
Methods: This single-arm, prospective, observational study included patients with recurrent high-grade (HG) NMIBC who received intravesical gem/doce. Treatment involved 6 weekly instillations (induction), followed by monthly instillations for 1 year (maintenance). Follow-up included cystoscopy every 3 months. Histological confirmation of intravesical recurrences was mandatory. The efficacy evaluation was assessed among 37 patients who received at least 4 instillations and had at least 1 cystoscopic evaluation. Primary outcome was HG disease-free survival, defined as time to histologically confirmed HG recurrence, and/or radiologically confirmed lymph node involvement, or distant metastasis. Adverse events were assessed.
Key findings and limitations: Thirty-nine patients with NMIBC were enrolled of whom 31 (79%) had Carcinoma in situ. Gem/doce was provided as third-line treatment in 87% (34/39) of the patients. Thirty-five patients had received BCG of whom 72% (28/39) were BCG-unresponsive. The median follow-up for patients without HG recurrence was 14 months (IQR: 7-25). The overall 1-year HG disease-free survival was 67% (95% CI: 53-85), and 73% (57-94) in patients with BCG-unresponsive NMIBC. Only one serious adverse event (grade 3) occurred. A limitation was the small sample size.
Conclusions and clinical implications: In patients with recurrent HG NMIBC who are unfit or reluctant to undergo radical cystectomy and in whom BCG failed, intravesical gem/doce was effective and safe.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
