[Bacillus Calmette-Guerin maintenance treatment in non-invasive bladder tumors: 1 year follow-up results of multicenter URO-BCG-4 trial]. / Traitement d'entretien par BCG-thérapie des tumeurs de vessie n'infiltrant pas le muscle (TVNIM): résultats à un an de l'étude multicentrique URO-BCG-4.

ABSTRACT

INTRODUCTION: Intravesical instillations of BCG remains the gold standard for intermediate and high risk NMIBC management. Maintenance treatment is recommended, however, the frequency of side effects responsible for the discontinuation of maintenance therapy over four out of five patients before the third year suggest a reduction or even spacing instillations. The objective of the study URO-BCG-4 was the evaluation of a new maintenance schedule by intravesical instillations of BCG combined reduced dose (third dose) and a decrease number of instillations per cycle (two or three). MATERIAL AND METHODS: Multicenter study of the French Association Oncologic Committee (12 university hospital centers), randomized, prospective, comparing reference diagram of BCG maintenance therapy one third of usual dose (group I) to a regimen combining third dose and decrease the number of instillations per cycle (two instead of three) (group II). We present the preliminary results at 1year of this Program of Clinical Research (CHU Rouen Promoter 2003-081). RESULTS: The rate of recurrence was respectively 9 and 7% (P=0.678) in groups I and II. The rate of tumor progression are 3 and 2.8% in groups I and II (P=1). Tolerance of intravesical instillations of BCG scored according to the WHO classification (Geneva 1979) was similar in the two groups. CONCLUSION: The decrease in the BCG dose (third dose) and the changes in the number and rate of instillations did not alter free tumor recurrence survival. The toxicity of intravesical instillations of BCG was identical in both groups. The use of the WHO classification has shown its limitations in the study of side effects of BCG as too complex and often not exhaustive. The rate of increase muscle was comparable in the two groups; however, a larger clinical experience is required.