138MO - A randomized study to compare outcomes of intravesical chemohyperthermia with mitomycin C vs intravesical BCG for intermediate and high risk non-muscle invasive bladder cancer (NMIBC)

Background

With the global shortage of bacillus Calmette-Guerin (BCG) coupled with the high recurrence rates of NMIBC, newer adjuvant intravesical treatment options are required. Although intravesical BCG remains the gold standard, the use of chemohyperthermia (CHT) as an alternative treatment is expanding all over the world. This study looks into the use of CHT with MMC as an alternative for BCG in NMIBC.

Methods

Between 2019 and 2021, 140 consenting NMIBC patients were randomised in a single centre study for 1-yr CHT (six weekly treatments and monthly maintenance treatments till 1 year) and 1-yr BCG immunotherapy (six weekly treatments and three weekly maintenance treatments at months 3, 6, and 12). Patients and physicians giving the interventions were aware of assignment. Follow up was done by 3 monthly cystoscopy and urine cytology. Adverse effects were graded by using the Modified Clavien Dindo Classification.

Results

The 12 month Recurrence Free Survival (RFS) was 97.10 % in the CHT group compared with 94.30 % in the BCG group (p = 0.53). No progression in the NMIBC was seen in CHT group whereas progression rate was 1.7% in BCG group. Regarding the side-effects, during the induction phase initially the side effects were more in the BCG group, but with the progression of the cycles the side effects of the CHT group increased, with the most common side effects being LUTS, UTI, Fever and Bladder spasms. The side effects during the maintenance phase were comparable between the CHT and BCG groups. All the side effects were classified as either grade 1 or grade 2 based on the Modified Clavien Dindo Classification. A concern is that the follow up period in this study was short and thus is underpowered. Furthermore, blinding of treatment for patients and physicians was impossible; this may have resulted in unavoidable bias.

Conclusions

CHT is a safe and effective treatment option in patients with intermediate- and high-risk NMIBC. A higher 12 month RFS in the CHT group was seen along with a comparable side effect profile. Based on the results above, CHT is an alternative option to intravesical BCG therapy as adjuvant treatment for intermediate and high-risk NMIBC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.