Il regime di mantenimento potenzia l’efficacia della chemioprofilassi endovescicale precoce e induzione settimanale nei confronti delle recidive degli uroteliomi vescicali a rischio intermedio.? Risultati di uno studio multicentrico.

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Abstract

[automatically translated] SCOPE OF WORK: Despite the efficacy of intravesical chemotherapy performed early after endoscopic resection of bladder urotheliomas NMI has been confirmed by a number of multi-center studies, doubt still remains the role of an additional regimen of maintenance in them more effective. This is even more uncertain whether to follow a single instillation of weekly instillations cycle. Aim of the study was to evaluate the usefulness of a monthly maintenance scheme for one year compared to one week induction for 6 weeks in patients undergoing TUR and early chemoprophylaxis with epirubicin. MATERIALS AND METHODS: They were randomized 577 patients with non-muscle invasive bladder cancer (NMI) at average risk of recurrence. Patients underwent TUR and chemotherapy early intravesical epirubicin (80 mg / 50 ml) within 6 hours of TUR and therefore, the intermediate-risk histologic confirmation of NMI, 482 patients were randomized into two arms: A. induction weekly rhythm for a total of 6 weeks; B. A longer retention arm on a monthly basis for a total of 12 months. Patients were maintained in followup with cytology and cystoscopy quarterly pace for two years and then half-year. RESULTS: There are to date 392 patients evaluable for efficacy and 487 for toxicity. A, 107 have relapsed (27.3%), 59 (30.7%) in arm A and 48 (24%) of the B arm with a median time to first recurrence of 13 months mean follow-up of 48 months (range 364 months). The recurrence rate at 6, 9 and 12 months was significantly higher (p = 0. 02) in arm A than in arm B. There was a severe adverse event (12:21%). A benefit in terms of relapse-free survival has emerged in favor of maintaining (p <004), as far as the effectiveness appears gradually come down to the suspension of the same. Two patients (12:41%) have not performed the second instillation for chemical cystitis. Thirty-nine patients (8%) have permanently discontinued treatment for toxicity? topical arisen in the course of induction (6.6%) or maintenance (4.4%) (p = 0.235). FINAL MESSAGE: In patients with medium TCCB risk of recurrence and underwent early chemoprophylaxis after TUR maintenance is significantly beneficial in terms of free time to relapse and recurrence rate, compared to the single induction for 6 weeks. There was a severe adverse event (00:21%). A benefit in terms of relapse-free survival has emerged in favor of maintaining (p <004), as far as the effectiveness appears gradually come down to the suspension of the same. Two patients (12:41%) have not performed the second instillation for chemical cystitis. Thirty-nine patients (8%) have permanently discontinued treatment for toxicity? topical arisen in the course of induction (6.6%) or maintenance (4.4%) (p = 0.235). FINAL MESSAGE: In patients with medium TCCB risk of recurrence and underwent early chemoprophylaxis after TUR maintenance is significantly beneficial in terms of free time to relapse and recurrence rate, compared to the single induction for 6 weeks. There was a severe adverse event (00:21%). A benefit in terms of relapse-free survival has emerged in favor of maintaining (p <004), as far as the effectiveness appears gradually come down to the suspension of the same. Two patients (12:41%) have not performed the second instillation for chemical cystitis. Thirty-nine patients (8%) have permanently discontinued treatment for toxicity? topical arisen in the course of induction (6.6%) or maintenance (4.4%) (p = 0.235). FINAL MESSAGE: In patients with medium TCCB risk of recurrence and underwent early chemoprophylaxis after TUR
Original languageItalian
Pages79-79
Number of pages1
Publication statusPublished - 2008

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