AUA 2023: The Effects of Sequential Mitomycin and BCG Treatment Versus BCG Monotherapy in Patients With High-risk Non-muscle Invasive Bladder Cancer: MITO-BCG

( Dr. Cosimo De Nunzio and colleagues evaluated the effect of sequential mitomycin-C and BCG vs. BCG monotherapy alone in patients with high-risk non-muscle invasive bladder cancer (HR NMIBC), in a study called the MITO-BCG trial. Their study aimed to evaluate recurrence-free survival of sequential Mitomycin (MMC) and Bacillus Calmette-Guérin (BCG) treatment versus BCG monotherapy in patients with High-risk Non-Muscle Invasive Bladder Cancer. The MITO-BCG trial is an open-label phase 4 study designed to evaluate the efficacy and safety of the sequential MMC and BCG combination treatment in patients with high-risk NMIBC.


Eligibility criteria included males with a diagnosis of High-risk NMIBC (T1 tumor, G3, CIS, or multiple and recurrent and large (>3 cm) Ta, G1G2 tumors or patients in the last EAU recurrence category (EAU/EORTC recurrence score >/=10), age> 40 years and < 75 years.

Patients were then randomized into two groups

Group 1: BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with 81 mg Connaught strain BCG

Group 2: Receiving BCG treatment with the same protocol but they also received a 40 mg mitomycin instillation the day before.

Response was assessed using cystoscopy and urine cytology every 12 weeks for 2 years. Primary endpoint is recurrence rate, while secondary endpoint is overall toxicity.

The protocol study started on March 2019. To date, they have enrolled 72 patients with a median age of 67 (IQR 59/73). Overall, 41 (57%) patients were randomized in Group 2, while 31 (43%) were randomized to Group 1. Mean Follow-up was 71±50 months.

In Group 1, 6/31 (19%) had a recurrence while 10/41 ( 24 %) had a recurrence in Group 2 (p=0.61). On Cox regression analysis no difference was seen in terms of recurrence when comparing both groups (HR: 1.23, 95% CI:0.46-3.50; p=0.640).

During follow-up only one patient experienced progression.

Nine patients experienced adverse events with 8 Grade I and 1 Grade 4 (orchiectomy). No statistically significant differences were recorded in terms of complications between groups.

Based on this interim analysis of the MITO-BCG study, the results suggest no differences in terms of recurrence-free survival when comparing BCG alone vs sequential Mitomycin and BCG treatment. Both treatments present good and comparable tolerability, though arguably may introduce an unnecessary side effect profile.

Presented by: Cosimo De Nunzio, MD, PhD, Associate Professor of Urology, Department of Molecular and Clinical Medicine, Sapienza University of Rome, Rome, Italy

Written by: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Associate Professor of Urology, University of California, Davis @tchandra_uromd @UCDavisUrology on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023