AUA 2022: A Randomized Study to Compare Outcomes of Intravesical Chemohyperthermia with Mitomycin C Versus Intravesical BCG for Intermediate and High Risk NMIBC

(UroToday.com) The 2022 American Urological Association (AUA) Annual Meeting included a session on non-invasive bladder cancer and a presentation by Dr. Karandeep Guleria discussing a randomized study assessing intravesical chemohyperthermia with Mitomycin C versus intravesical BCG for intermediate and high risk non-muscle invasive bladder cancer (NMIBC). With the global shortage of 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 as an alternative treatment is expanding all over the world. This study looks to compare the efficacy, safety, and tolerability of intravesical chemohyperthermia with Mitomycin C vs BCG for intermediate and high-risk NMIBC.

Between 2019 and 2021, 140 NMIBC patients were randomized in a single-center study for 1 year of chemohyperthermia (six weekly treatments and monthly maintenance treatments till 1 year) and 1 year of 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 and set protocols. Follow-up was done by cystoscopy every 3 months along with urine cytology.

In this trial, the 12-month recurrence-free survival was 97.1% in the chemohyperthermia group compared with 94.3% in the BCG group (p = 0.53). No progression in the NMIBC was seen in the chemohyperthermia group whereas the progression rate was 1.7% in the 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 induction cycles, the side effects of the chemohyperthermia group increased, with the most common side effects being LUTS, UTI, fever, and bladder spasms. Side effects during the maintenance phase were comparable between the chemohyperthermia and BCG groups. All the side effects were classified as either grade 1 or grade 2 based on the modified Clavien Dindo Classification. Dr. Guleria noted several limitations from this trial, namely (i) that the follow-up period was short and thus the study is underpowered, and (ii) that blinding of treatment for patients and physicians was impossible and this may have resulted in unavoidable bias.

Dr. Guleria concluded his presentation by discussing a randomized study assessing intravesical chemohyperthermia with Mitomycin C versus intravesical BCG for intermediate and high-risk NMIBC with the following take-home messages:

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

 

Presented by: Karandeep Guleria, MD, MS, All India Institute of Medical Sciences, New Delhi, India

Co-Authors: Rajeev Sood, Hemant Goel, Umesh Sharma, Anurag Singla, New Delhi, India

 Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 American Urological Association (AUA) Annual Meeting, New Orleans, LA, Fri, May 13 – Mon, May 16, 2022.

email news signup