RESUMO
BACKGROUND: High risk non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical BCG-therapy. In case of BCG failure radical cystectomy (RC) is the treatment of choice. Nevertheless, many patients are unfit for or unwilling to undergo RC. Hyperthermic intravesical chemotherapy (HIVEC) is a promising bladder sparing therapy in such cases. It was the purpose of the study to evaluate the efficacy of HIVEC in patients with BCG failure as well as in BCG naïve patients in case of BCG shortage or given contra-indications for BCG. METHODS: We analyzed the first 60 patients who received hyperthermic intravesical chemotherapy (HIVEC) at our department. The therapy regimen consisted of an induction course of 6 weekly sessions, followed by a maintenance course with 6 monthly sessions. Fluorescence cystoscopy with urine cytology and bladder mapping was performed after completion of induction and maintenance therapy at 3 and 12 months. About 68.6 % had received a recurrence after or during BCG treatment, 55% of the subjects were BCG-unresponsive NMIBC according to EAU guidelines. RESULTS: The median follow up was 12 months with 12 cycles of HIVEC therapy being administered on average, representing completion of induction and maintenance therapy with 6 cycles each. The 1- and 2-year recurrence-free-survival (RFS) was 67% and 40% respectively. Only one out of 60 patients developed progression to muscle invasion with progression-free-survival (PFS) of 98% at 2 years. No statistical differences were found in RFS for patients failure to BCG compared to patients that were BCG-naïve (BCG unresponsive vs. BCG-naïve) and patients that carried carcinoma in situ (CIS) compared to patients without CIS (CIS vs. no CIS). CONCLUSION: Chemohyperthermia using HIVEC results in high recurrence-free survival and a 2-year progression-free survival rate of 98% with a bladder preservation rate of almost 80%. Comparing our data, HIVEC shows better oncological results together with better tolerability and safety making HIVEC a good alternative for patients who refuse radical cystectomy or who are ineligible for radical cystectomy.