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ElectroMotive drug administration (EMDA) of mitomycin C as first line salvage therapy in high risk “BCG-failure” non muscle invasive bladder cancer: 3 years followup outcomes
... Until approximately 20 years ago, pharmacological treatment was based on the passive diffusion of the drugs used, mainly mitomycin C (MMC) and epirubicin, by infusing the drug dissolved in a saline solution into the bladder and allowing it to penetrate the bladder mucosa during approximately 2 h. More recently, pharmacological treatment has evolved toward the use of devices that allow the drug to actively enter the bladder mucosa [3][4][5][6][7][8][9][10]. Presently, the 2 main methods used to achieve an active diffusion are thermochemotherapy, which is carried out using Carando/Zazzara/Cotrufo/Ludovico Urol Int 2 DOI: 10.1159/000502663 catheters that increase the temperature of the bladder up to 43 ° C [11], and the electromotive drug administration (EMDA), which induces an ionophoresis of the drug used [3]. ...
Background:
Topical therapy of nonmuscle-invasive bladder cancer (NMIBC) is based on immunotherapy with Bacillus Calmette-Guerin and chemotherapy administered by passive instillation, but an active drug administration achieves a better concentration of the drugs in the bladder.
Aim:
This study aimed to investigate the effectiveness of electromotive drug administration (EMDA) of mitomycin C (EMDA/MMC) in intermediate- and high-risk NMIBC patients 6 months after the end of induction treatment.
Materials and methods:
Sixty-five patients diagnosed with histologically confirmed NMIBC, with a complete transurethral resection of all visible tumors underwent EMDA/MMC. Primary endpoint was the proportion of responders at 3 or 6 months.
Results:
Data on follow-up were available for 62 subjects at 3 months and 45 at 6 months. EMDA was effective in intermediate- and high-risk patients: because of the small number of cases no conclusions can be drawn on the efficacy in the low-risk group. No difference in the response to treatment between intermediate- (83.3%) and high-risk (84%) patients could be seen.
Conclusions:
EMDA/MMC is a useful technique for an effective and safe treatment of primary and recurrent NMIBC, and a valuable therapeutic option in intermediate- and high-risk NMIBC patients.
... On this background, the aim of this study was to explore the role of EMDA®-MMC as first line salvage treatment in selected patients with HGNMIBC unresponsive to intravesical BCG, with a follow-up of 3 years [22]. ...
Abstract Background In case of high grade non-muscle invasive bladder cancer (HG-NMIBC), intravesical BCG represents the first-line treatment; despite the “gold” standard therapy, up to 50% of patients relapse, needing radical cystectomy. Hence, alternative therapeutic strategies have been developed. The aim of the study was to evaluate a first-line salvage treatment with EMDA®-MMC in patients with HGNMIBC unresponsive to BCG. Methods We carried out a prospective, single-center, single-arm Phase II study in order to evaluate the efficacy (in terms of recurrence and progression) and the safety of the EMDA®-MMC treatment in 26 (21 male, 5 female) consecutive patients with “BCG refractory” HGNMIBC on a 3 years follow-up. EMDA®-MMC treatment consisted of 40 mg of MMC diluted in 100 ml of sterile water retained in the bladder for 30 min with 20 mA pulsed electric current. EMDA®-MMC regimen consisted of an induction course of 6 weekly instillations followed by a maintenance course of 6 monthly instillations. Follow-up was performed with systematic mapping biopsies of the bladder (with sampling in the prostatic urethra for men), voiding and washing urinary cytology, radiological study of the upper urinary tract. We performed Survival Kaplan-Meier curves and Log-rank test in order to analyze high grade disease-free survival. Results At the end of follow-up, 16 patients (61.5%) preserved their native bladder; 10 patients (38.4%) underwent radical cystectomy, in 6 patients (23.1%) for recurrent HGNMIBC and in 4 patients (15.4%) for progression to muscle-invasive disease. At the end of follow-up, stratifying patients based on TNM classification (TaG3, T1G3, Cis, TaT1G3 + Cis), disease-free rates were 75, 71.4, 50 and 25%, respectively; survival curves showed statistically significant differences (p value
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