[Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial].

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.

Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie. 2020 Sep 02 [Epub ahead of print]

J Breton, S Bernardeau, M Vallée, P Pillot, C Lebacle, P-O Delpech, T Charles, C Biscans, A Vallat, C Pfister, J Irani

Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France. Electronic address: ., Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France., Service d'urologie, hôpital Bicêtre AP-HP, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France., Service d'urologie, CHU de Rouen, 37, boulevard Gambetta, 76000 Rouen, France.