| Autor: |
Martínez-Piñeiro, J.A, Flores, N, Isorna, S, Solsona, E, Sebastián, J.L, Pertusa, C, Rioja, L.A, Martínez-Piñeiro, L, Vela, R, Camacho, J.E, Nogueira, J.L, Pereira, I, Resel, L, Muntañola, P, Galvis, F, Chesa, N, De Torres, J.A, Carballido, J, Bernuy, C, Arribas, S |
| Předmět: |
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| Zdroj: |
BJU International; May2002, Vol. 89 Issue 7, p671-680, 10p, 5 Charts, 3 Graphs |
| Abstrakt: |
Objectives To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille Calmette-Guérin (BCG) against the standard dose (81 mg) in patients with superficial bladder cancer, assessing recurrence, progression and differences in toxicity. Patients and methods Five hundred patients with superficial bladder cancer (Ta, T1, Tis) were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG Connaught strain (weekly×six and thereafter fortnightly×six) either with the standard or RD instillation. Results All but one of the 500 patients were evaluable for efficacy and toxicity (252 in the standard arm and 247 in the RD arm). The median follow-up was 69 months (maximum 104); 71 (28%) patients in the standard arm and 76 (31%) in the RD arm developed recurrences; the median time to recurrence has not yet been attained, but at 5 years the mean (sd) percentage of recurrence-free patients was 70.5 (3.12) and 70.4 (3.1) for the standard and RD arms, respectively. In patients presenting with multifocal tumours, the standard dose was more effective against recurrences than the RD (P =0.0151). In those with G3 and high-risk tumours overall, the superiority of the standard dose was marginal (P =0.060 and P =0.082). Twenty-nine (11.5%) tumours in the standard arm and 33 (13.3%) in the RD arm progressed to invasive disease; the median time to progression has not yet been attained, but the percentage of progression-free patients at 5 years was 88.8 (2.23) and 86.9 (2.31) for the standard and RD arms, respectively. The standard dose was more effective than the RD against progression only in patients with multifocal disease (P =0.048). Twelve (4.8%) cystectomies were performed in the standard and 15 (6.1%) in the RD arm. Currently, 106 (21.2%) patients have died, but only 38 (7.6%) from bladder cancer, i.e. 20 (7.9%) in the standard and 18 (7.5%) in RD arm. Overall the... [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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