Thermochemotherapy with epirubicin for recurrent non-muscle invasive bladder cancers: A pilot study using the UniThermia system

Introduction: Bladder cancer (BC) ranks as the 10th most common cancer globally, predominantly affecting older adults. Non-muscle invasive BC (NMIBC) are known for high recurrence and progression rates despite standard treatments. Objective: This study assesses the efficacy of chemohyperthermia with epirubicin in Bacillus Calmette–Guérin (BCG)-naïve patients with either primary or recurrent NMIBC. Methods: We conducted a prospective pilot study on this cohort using the bladder wall thermochemotherapy – UniThermia platform, with a follow-up period of 24 months. Nine NMIBC patients (88.89% male; mean age: 70.22 ± 11.82 years) were prospectively enrolled. Inclusion criteria were NMIBC stage Ta–T1 with BCG-naïve status; patients with carcinoma in situ (CIS) were excluded. Results: Tumor staging revealed pTa in six patients and pT1 in three patients; tumor grading included G1 (11.11%) and G2 (88.89%). No CIS was detected. All patients received six weekly chemohyperthermia instillations. At the 24-month follow-up, four patients (44.4%) achieved a complete response with no recurrences; all remained alive with no disease progression. All recurrences were low-grade pTa. Conclusion: These findings suggest that chemohyperthermia with epirubicin may offer therapeutic advantages over intravesical BCG or conventional chemotherapy, especially for BCG-intolerant or refractory patients. Study limitations include the small sample size and limited follow-up duration. Further multicenter studies are warranted to validate these preliminary results. Overall, chemohyperthermia with epirubicin appears to be a promising alternative for the management of recurrent NMIBC when standard BCG treatment is ineffective or unavailable.