- •What is already known about this subject?
Abstract
Background
Nowadays, there is no standard non-surgical treatment for patients with non-muscle
invasive bladder cancer (NMIBC) in whom Bacillus Calmette-Güerin (BCG) therapy has
failed.
Objectives
to assess the clinical and oncological outcomes of sequential treatment with BCG and
Mitomycin C (MMC) administered with Electromotive Drug Administration (EMDA) in patients
with high-risk NMIBC who fail BCG inmunotherapy.
Material and methods
We retrospectively studied patients with NMIBC who failed BCG and received alternating
BCG and Mitomycin C with EMDA between 2010 and 2020. Treatment schedule consisted
in an induction therapy with 6 instillations (BCG, BCG, MMC + EMDA, BCG, BCG, MMC + EMDA)
and a 1-year maintenance.
Complete response (CR) was defined as the absence of high-grade recurrences (HG) during
follow-up, and progression was defined as the occurrence of muscle invasive or metastatic
disease. CR rate was estimated at 3, 6, 12 and 24 months. Progression rate and toxicity
were also assessed.
Results
Twenty-two patients were included with a median age of 73 years. Fifty percent of
tumors were single, 90% were smaller than 1.5cm, 40% were GII (HG) and 40% were Ta.
Complete response rate was 95.5%, 81% and 70% at 3 and 6 months, 12 months and 24
months, respectively.
With a median follow-up of 28.8 months, 6 patients (27%) presented HG recurrence and
only 1 patient (4.5%) progressed and ended in cystectomy. This patient died due to
metastatic disease. Treatment was well tolerated and 22% of the patients presented
adverse effects, being dysuria the most frequent one.
Conclusion
Sequential treatment with BCG and Mitomycin C with EMDA achieved good responses and
low toxicity in selected patients who did not respond to BCG. Only one patient ended
in cystectomy and died due to metastatic disease, therefore, cystectomy was avoided
in most cases.
Micro-Abstract
We evaluated the result of bladder preservation in patients with nonmuscle invasive
bladder cancer in whom Bacillus Calmette-Guerin (BCG) therapy had failed. They received
BCG and Mitomycin C instillations administered with Electromotive Drug Agministration
(EMDA) and we evaluated the response and tolerability. They seem to be safe and to
provide good responses in these patients, without a high progression rate.
Keywords
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Article info
Publication history
Accepted:
March 4,
2023
Received in revised form:
February 22,
2023
Received:
October 13,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Published by Elsevier Inc.
