ASCO GU 2021: Efficacy of Chemohyperthermia in Patients with High-Risk Non-Muscle Invasive Bladder Cancer Who Fail BCG Therapy

( BCG-unresponsive non-muscle invasive bladder cancer remains a challenging disease to treat given the limited treatment options and a proportion of this patient population that are either unfit or unwilling to undergo radical cystectomy. Hyperthermic Intra-Vesical Chemotherapy (HIVEC) is a treatment option for these patients, which includes intravesical instillation of a chemotherapeutic agent with pre-treatment warming of the solution typically to 41-43ºC. At the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), Dr. Geraldine Pignot presented results evaluating HIVEC efficacy, specifically 1-year disease-free survival rate and bladder preservation rate in patients with high-risk non-muscle-invasive bladder cancer who fail BCG therapy or are contraindicated to BCG.

This study included 53 patients between June 2016 and October 2019 treated with HIVEC for high-risk non-muscle-invasive bladder cancer who failed BCG therapy or were contraindicated to BCG. The protocol included 6 instillations of 40 mg mitomycin-C at a temperature of 43ºC for 60 minutes. The evaluation included cystoscopy and cytology every three months and efficacy was measured as 1-year recurrence-free survival rate.


Among the 53 patients enrolled in this trial, the median age was 72 [range: 39-93] years, including 29 patients that failed BCG and 24 that were contraindicated for BCG. 81% of the patients were male and 45.3% of patients with high-risk disease had associated CIS. Over a median follow-up of 18 months (range 5-43), the bladder preservation rate was 92.4%, the recurrence-free survival rate at 3 months was 94.3%, 6 months was 80.4%, 12 months was 60.5%, and 18 months was 46.2%. The recurrence-free survival rate at 12 months for those not suited for BCG was 70% compared to 52.2% for those that had failed BCG (p=0.077):


Three patients progressed to muscle-invasive disease, all in the failed BCG group and all in the very high-risk EORTC group. Two patients experienced metastatic progression and died from bladder cancer. With regards to safety, there were no grade 3-4 adverse events, and the most common grade 1-2 adverse events were urinary urgency (40.1%) and dysuria (40.1%).

Dr. Pignot concluded her presentation of HIVEC for high-risk non-muscle-invasive bladder cancer with the following conclusions:

  • Chemohyperthermia using HIVEC device achieved a recurrence-free survival rate of 60% at 1 year and enabled a bladder preservation rate of 92%
  • Given the low risk of progression in patients unable to receive BCG, HIVEC could be a good alternative
  • Conversely, for patients with very high-risk tumors that fail BCG, cystectomy should remain the standard of care and HIVEC may be discussed cautiously for patients who are not eligible for surgery and well informed of the risk of progression to muscle-invasive disease
Presented by: Geraldine Pignot, MD, Ph.D., Institut Paoli-Calmettes, Marseille, France

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_md during the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (#GU21), February 11th-February 13th, 2021
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