Introduction: the standard treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) are the intravesical instillations with Bacillus Calmette-Guérin (BCG), shortage has led to the testing of new treatments. We present the results of our series of patients treated with mitomycin C (MMC) with recirculating chemohyperthermia (CHT).
Material and methods: Prospective observational study. Patients with high-risk NMIBC in whom treatment with intravesical instillations with CHT was indicated due to poor response to prior BCG, absence of BCG availability or inclusion in a clinical trial, between November 2014 and May 2017.
The protocol followed was 40 mg of MMC diluted in 40 mL of distilled water at 43°C recirculating for 60 minutes with the COMBAT BRS® system, an instillation weekly for 6 weeks (induction) and monthly for 6 months (maintenance).
Results: we analyzed 75 patients with a median age of 75.9 years, 57 of them with primary NMIBC. We found 44 Ta, 1 Tis and 30 T1 tumors; 69 high grade and 6 low grade. According to them classification of the European Guidelines of Urology, 71 patients correspond to high risk and 4 to intermediate.
With a median follow-up of 19 months, there were 22 recurrences (recurrence-free survival at 19 months 70.7%), with a median time to recurrence of 10.7 months, and 10 progressions (5 of them to T2). There were 8 deaths (of which 2 attributable to the cancer). 18 patients did not complete the protocol of instillations, most of them due to adverse effects in the induction phase.
Conclusions: the adjuvant treatment in high risk NMIBC with MMC in the QHT regime offers promising results in our experience. However, longer follow-up is needed and a bigger series is needed to be able to consider it an alternative to BCG in this scenario.