{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T06:26:19Z","timestamp":1781677579648,"version":"3.54.5"},"reference-count":31,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"15","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2002,8,1]]},"abstract":"<jats:p> PURPOSE: The aim of this phase I study was to determine the safety and toxicity profile of gemcitabine administered as an intravesical agent in patients with transitional-cell carcinoma (TCC) of the bladder. <\/jats:p><jats:p> PATIENTS AND METHODS: Patients with superficial bladder cancer refractory to intravesical bacillus Calmette-Gu\u00e9rin (BCG) therapy and refusing a cystectomy were considered eligible for the trial. Gemcitabine was given in the bladder for 1 hour twice weekly in 100 mL sodium chloride for a total of six treatments. After a 1-week break, a second course of six treatments over 3 weeks was given, followed by response assessment. Four dose levels were explored: 500 mg, 1,000 mg, 1,500 mg, and 2,000 mg. <\/jats:p><jats:p> RESULTS: Eighteen patients completed therapy: three at 500 mg, six at 1,000 mg, three at 1,500 mg, and six at 2,000 mg. No grade 3 or 4 toxicity was observed at 500 mg. At 1,000 mg, three patients developed hematuria and one had a skin reaction resembling grade 3 hand-foot syndrome. Three patients at 1,500 mg had no grade 3 or 4 toxicity. Of six patients at 2,000 mg, one had grade 3 thrombocytopenia and neutropenia without infection. Seven patients had a complete response (negative cytology and posttreatment biopsy), and four patients had a mixed response (negative bladder biopsy but positive cytology). <\/jats:p><jats:p> CONCLUSION: Gemcitabine has substantial activity as an intravesical agent in BCG-refractory TCC and warrants further investigation. Therapy given twice weekly was associated with minimal bladder irritation and tolerable myelosuppression. The recommended phase II dose for twice-weekly therapy is 2,000 mg. <\/jats:p>","DOI":"10.1200\/jco.2002.02.066","type":"journal-article","created":{"date-parts":[[2002,10,1]],"date-time":"2002-10-01T21:58:26Z","timestamp":1033509506000},"page":"3193-3198","source":"Crossref","is-referenced-by-count":141,"title":["Phase I Trial of Intravesical Gemcitabine in Bacillus Calmette-Gu\u00e9rin\u2013Refractory Transitional-Cell Carcinoma of the Bladder"],"prefix":"10.1200","volume":"20","author":[{"given":"Guido","family":"Dalbagni","sequence":"first","affiliation":[{"name":"From the Department of Urology; the Division of Epidemiology and Biostatistics; Pharmacology and Analytical Laboratory; and the Genitourinary Oncology Service, Division of Solid Tumor Oncology, 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; 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