Instillation préopératoire immédiate (IPOI) de mitomycine C comparée à l’instillation postopératoire précoce (IPOP) dans les tumeurs de la vessie. Étude de phase II randomisée

Abstract

A single immediate instillation of mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate-risk patients with NMIBC. Actually, post-TURB instillation is seldom used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of mitomycin C. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score. Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-up was comparable: 12,3±1,6 months in the SI group and 10,2±4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn't have any instillation. We did not identify significant differences in disease-free interval. Tolerance at 1 month after TURB was similar in both groups. Tolerance and efficacy were not significantly different. As expected, logisitics were easier for the health providers in the pre-TURB group where all patients had their instillation conversely to the post-TURB group. These results suggest that the advantages of a single immediate pre-TURB instillation warrant further evaluation of this strategy in a phase III randomized trial.