{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T21:54:53Z","timestamp":1786658093881,"version":"build-2736575974"},"reference-count":40,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"18","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2006,6,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> The aim of this phase II study was to determine the efficacy of gemcitabine administered as an intravesical agent in patients with bacille Calmette-Gu\u00e9rin (BCG) \u2013refractory transitional cell carcinoma of the bladder. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients with superficial bladder cancer refractory or intolerant to intravesical BCG therapy and refusing a cystectomy were considered eligible for the trial. Eligible patients received two courses of intravesical gemcitabine twice weekly at a dose of 2,000 mg\/100 mL for 3 consecutive weeks, with each course separated by 1 week of rest. Patients were evaluated for response at 8 weeks, then every 3 months to 1 year. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Thirty eligible patients were included on study. The median follow-up for all the patients was 19 months (range, 0 to 35 months). Of the 30 patients, 15 (50%; 95% CI, 32% to 68%) achieved a complete response (CR). Twelve patients had tumor recurrence with a median recurrence-free survival time of 3.6 months (95% CI, 2.9 to 11.0 months). Two patients maintained a CR at 23 and 29 months, respectively. The 1-year recurrence-free survival rate for patients with a CR was 21% (95% CI, 0% to 43%). Two patients progressed to a higher stage while receiving gemcitabine treatment. The median follow-up for patients who did not have a progression or a cystectomy was 19 months (range, 2 to 35 months). Eleven patients (37%) underwent a cystectomy subsequent to gemcitabine therapy. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Gemcitabine has activity in a high-risk patient population and remains a viable option for some patients who refuse cystectomy. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2005.05.2720","type":"journal-article","created":{"date-parts":[[2006,6,16]],"date-time":"2006-06-16T23:34:12Z","timestamp":1150500852000},"page":"2729-2734","source":"Crossref","is-referenced-by-count":154,"title":["Phase II Trial of Intravesical Gemcitabine in Bacille Calmette-Gu\u00e9rin\u2013Refractory Transitional Cell Carcinoma of the Bladder"],"prefix":"10.1200","volume":"24","author":[{"given":"Guido","family":"Dalbagni","sequence":"first","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Russo","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Bochner","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leah","family":"Ben-Porat","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Sheinfeld","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pramod","family":"Sogani","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Machelle S.","family":"Donat","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry W.","family":"Herr","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Bajorin","sequence":"additional","affiliation":[{"name":"From the Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Division of Solid Tumor Oncology, and the Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.53.1.5"},{"key":"R2","unstructured":"Reuter VE, Melamed MR: The lower urinary tract, in Sternberg S (ed): Diagnostic Surgical Pathology . 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