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Safety evaluation of sequential Mitomycin and Bacillus Calmette-Guérin treatment versus Bacillus Calmette-Guérin monotherapy in patients with high risk non-muscle invasive bladder cancer: MITOBCG study (EUDRACT Number 2017-004540-37) preliminary results

  • De Nunzio C.,
  • Nacchia A.,
  • Lombardo R.,
  • Voglino O.A.,
  • Baldassarri V.,
  • Costantino L.,
  • Simone G.,
  • Pastore A.,
  • Tubaro A.
Sapienza, Dept. of Urology, Rome, Italy

Introduction & Objectives

Aim of our study was to evaluate safety of sequential Mitomycin and Bacillus Calmette-Guérin (BCG) treatment versus BCG monotherapy in patients with High risk Non-Muscle Invasive Bladder Cancer.

Materials & Methods

MITO-BCG 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: 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, ability of consent. Patients are randomized in two groups: first with BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with 81 mg Connaught strain BCG and second receiving BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before. Response will be assessed using cystoscopy and urine citology every 12 weeks for 2 years. Primary end points are recurrence rate; secondary end points are overall toxicity.


The protocol study started on March 2019. Nowadays we enrolled 36 patients with a median age of 67 (IQR 59/73). Overall, 15 (42%) patients were randomized in the group of sequential combination therapy and 21 (48%) in the group of monotherapy with BCG. After treatment, six patients experienced a post-treatment AE, three (50%) in the group of combination therapy and three (50%) in the group of BCG. Five AEs (urethral sub-stenosis, fever, asthenia, fainting, cystitis) were CTCAE grade I. None of them needed further treatment. Only one AE was a grade III, acute epididymo-orchitis with abscess requiring orchiectomy in the monotherapy BCG group (Table). No significative differences were found between the two groups (Table).

Table: Questionnaires and AEs after treatment

  Monotherapy BCG Group Combination Therapy Group p
Patients 21 (48%) 15 (42%)  
IPSS          9 (IQR 5/11)         11 (IQR 9/13) 0,21
sIPSS 5 (IQR 3/7) 8 (IQR 5/10) 0,27
vIPSS 2 (IQR 1/5) 5 (IQR 2/6) 0,31
NIH-CPSI total 10 (IQR 9/11) 10 (IQR 8/21) 0,13
NIH-CPSI pain 3 (IQR 2/4) 3 (IQR 2/7) 0,12
NIH-CPSI micturition 4 (IQR 2/5) 4 (IQR 3/5) 0,74
NIH-CPSI Qol 4 (IQR 3/4) 4 (IQR 1/9) 0,14
PUF total 17 (IQR 10/22) 17 (IQR 11/23) 0,91
PUF SS 10 (IQR 8/11) 10 (IQR 8/11) 0,89
PUF BS 7 (IQR 6/8) 7 (IQR 5/8) 0,86
Grade I
Grade II
Grade III
Grade IV
Grade V
3 (50%)
2 (67%)
1 (33%)
3 (50%)
3 (100%)


Preliminary results of our experience (MITOBCG study) support that sequential combination therapy with mytomicin and BCG is a safety treatment in high risk non muscle invasive bladder cancer.

Tags: EAU21