SEQUENTIAL INTRAVESICAL IMMUNOCHEMOTHERAPY FOR STAGES Ta and T1 TRANSITIONAL CELL CARCINOMA OF THE BLADDER: AN UPDATE

Objectives: To present an update of our experience with sequential immuno-chemotherapy using bacillus Calmette-Guerin (BCG) and epirubicin in superficial bladder tumors. In addition, the question of whether to start with BCG or epirubicin is answered. Methods: Between January 1993 and December 2001, 156 patients with histologically proven Ta and T1 bladder transitional cell carcinoma were included in a prospective randomized study. Following transurethral resection of the bladder tumor (TURBT), patients were randomly assigned to 1 of 2 groups. Patients in group 1 received weekly doses of 150 mg BCG alternating with 50 mg epirubicin for 6 weeks. Maintenance was carried out by a monthly dose of BCG alternating with epirubicin, to complete 1 year of treatment. Patients in group 2 received the same protocol, but with a reversed order with epirubicin being used initially. Results: 149 patients, 114 men and 35 women with a mean age of 55 years, were evaluable. 7 patients were excluded due to severe side effects. Mean and median follow-up was 42.8 and 43 months, respectively. In the whole series recurrence rate was 18.1%, recurrence rate per year was 0.06, mean interval to first recurrence was 29 months and progression rate was 12%. Side effects developed in 40 patients (25.6%) and were mostly in the form of mild cystitis (26 patients). The 2 groups of therapy were comparable regarding recurrence rate, recurrence rate per year, progression rate and side effects. Conclusions: The sequential therapy is effective in recurrence prophylaxis of superficial bladder tumors. The side effects were less frequent than in our historical controls treated with BCG alone. It does not matter to start with epirubicin or BCG in this regimen. L' Immunochimiotherapie Intravesicale Sequentielle pour Carcinoma a Cellules Transitionnelles Stades Ta et T1 de la Vessie: Une Mise a Jour Objectifs: Presenter une mise a jour de notre experience en matiere d'immuno-chimiotherapie sequentielle utilisant le bacille de Calmette-Guerin (BCG) et l'Epirubicin dans les tumeurs superficielles de vessie. En outre, la question de commencer par BCG ou epirubicin est traitee. Methodes: Entre janvier 1993 et decembre 2001, 156 patients presentant un carcinome a cellules transitionnelles de la vessie au stade pTa et pT1 histologiquement prouve ont ete inclus dans une etude randomisee. Apres la resection transurethrale de la tumeur de vessie (TURBT), des patients ont ete aleatoirement affectes a 1 de 2 groupes. Les patients dans le groupe 1 ont recu des doses hebdomadaires 150 mg de BCG alternant avec 50 mg d'epirubicin pendant 6 semaines. L'entretien a ete effectue par des doses mensuelles de BCG alternant avec l'epirubicin, pendant 1 an de traitement. Les patients dans le groupe 2 ont recu le meme protocole, mais avec un ordre inverse avec l'epirubicin etant employe au debut du traitement. Resultats: 149 patients, 114 hommes et 35 femmes presentant un âge moyen de 55 ans, etaient inclus dans l'etude. 7 patients etaient exclus a cause d'effets secondaires graves. Le suivi moyen et median etait de 42.8 et 43 mois, respectivement. Dans toute la serie le taux de recidive etait de 18.1%, le taux de recidive par an etait de 0.06, l'intervalle moyen a la premiere recidive etait de 29 mois et le taux de progression etait de 12%. Les effets secondaires ont ete constates chez 40 patients (25.6%) dont la plupart etaient des cystites a minima (26 patients). Les 2 groupes etaient comparables concernant le taux de recidive, le taux de recidive par an, le taux de progression et les effets secondaires. Conclusions: La therapie sequentielle est efficace dans la prophylaxie de recidive des tumeurs superficielles de vessie. Les effets secondaires etaient moins frequents que dans nos precedentes series traitees avec BCG seul. Il importe tres peu de commencer par l'epirubicin ou le BCG dans ce protocole. African Journal of Urology Vol.9(3) 2003: 117-122