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

Abstract

Introduction: Bladder cancer (BC) ranks as the 10^th 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.

Keywords

Chemohyperthermia / Epirubicin / Intermediate-risk bladder cancer / Non-muscle invasive bladder cancer

Funding

A postdoctoral grant awarded to Assoc. Prof. Dr. Mihai Dorin Vartolomei by The Executive Unit for Financing Higher Education, Research, Development, and Innovation (UEFISCDI): [PN-III-P1-1.1-PD-2019-0085] for this study.

Conflict of interest

Mihai Dorin Vartolomei is an Editorial Board Member of this journal but was not involved in the editorial or peer-review process for this paper, either directly or indirectly. Separately, all other authors declare that they have no known competing financial interests or personal relationships that could have influenced the work reported in this paper.

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