PubMed · 10407950
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B Truniger. 1999-05-15. [Fatal cure].. https://pubmed.ncbi.nlm.nih.gov/10407950/
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OBJECTIVES: To assess in a pilot study the safety, tolerability, and technical feasibility of administering intravesical valrubicin immediately after transurethral resection of bladder tumors (TURBT) in patients with superficial bladder cancer and to evaluate the optimal dose of valrubicin and its systemic absorption. METHODS: Twenty-two patients with recurrent or newly diagnosed Stage Ta or T1 transitional cell tumors received a single dose of 400 mg, 600 mg, or 800 mg of intravesical valrubicin immediately after TURBT. Four patients thought to be at high risk of recurrence were followed up with five additional doses of 800 mg valrubicin, given weekly. RESULTS: The use of valrubicin after TURBT was generally well tolerated. Little evidence was found to suggest a direct relationship among the dose of valrubicin, the time between the end of TURBT and drug instillation, and the occurrence of most bladder symptoms. The most commonly reported adverse events included dysuria (77%), hematuria (59%), and urgency/frequency (23%). Pharmacokinetic analyses revealed that the mean systemic exposure to valrubicin and its metabolites depended on the extent of the TURBT and the damage to the bladder wall. CONCLUSIONS: The results of this study indicated that administration of valrubicin immediately after TURBT is feasible.
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BACKGROUND AND OBJECTIVE: Evaluate the efficacy and toxicity of alternating intravesical instillation of Bacillus Calmette-Guerin(BCG) and Interferon alpha2-b (IFN) in the treatment and prevention of recurrence of superficial transitional cell carcinoma (TCC) of the urinary bladder. METHODS: Patients with Ta, T1 tumors and carcinoma in situ, either recurrent (TaG1, T1G1) or primary/recurrent TaG2 TaG3, T1G2, T1G3 and Tis (T: Tumor stage, G: grade) are eligible. All patients received intravesical BCG 81 mg on Weeks 1, 3, 5 and 7 and IFN 100 million units on Weeks 2, 4, 6 and 8. Cystoscopy performed 4 weeks after completion of therapy, and every 3 months thereafter. RESULTS: There was a total of 37 patients. Thirteen had TaG2, 13 T1G2, 1 T1G1, 4 TaG1, 1 TaG3, 3 T1G3 and 7 Tis (5 concurrent with other above tumors). Index lesion cleared in 7/10 patients. With a median follow-up of 26.2 month, 22 patients (59%) failed above therapy. Median time to treatment failure was 7 months. Seven, 6 and 9 patients recurred at a higher, lower and same stage or grade respectively. No grade 3 or 4 toxicity was encountered. CONCLUSIONS: Alternating intravesical BCG and IFN is effective and well tolerated therapy for superficial TCC of urinary bladder.