Electromotive Drug Administration of Mitomycin C (EMDA/MMC) versus Intravesical Immunotherapy with Bacillus Calmette-Guérin (BCG) in Intermediate and High Risk Non Muscle Invasive Bladder Cancer

2021 ◽  
pp. 1-8
Author(s):  
Michele Zazzara ◽  
Arjan Nazaraj ◽  
Marcello Scarcia ◽  
Giuseppe Cardo ◽  
Roberto Carando ◽  
...  

<b><i>Background:</i></b> Although TURB of tumor (TURBT) by itself can eradicate a non-muscle-invasive bladder cancer (NMIBC) completely, these tumors commonly recur and can progress to MIBC. It is, therefore, necessary to consider adjuvant therapy in most patients. The primary objective of the present study was to report our experience with EMDA/MMC and BCG, considering efficacy, progression, and recurrence, as adjuvant therapy in NMIBC patients; the secondary objective was to assess the efficacy of EMDA/MMC versus BCG as a comparative treatment. <b><i>Methods:</i></b> Between April 2016 and February 2020, a series of 216 patients, with a diagnosis of intermediate- and high-risk NMIBC after TURBT, underwent adjuvant intravesical therapy. In 26 cases with a failure of the treatment, in patients unfit and unwilling for radical cystectomy, a repeated intravesical therapy was performed (2 had a twice repetition). Out of 244 adjuvant therapies, 140 EMDA/MMC and 104 BCG treatments were done. The following data were collected for each patient: baseline demographics and clinical data and perioperative and postoperative data. Overall patients’ adjuvant intravesical therapies were included in a prospectively maintained institutional database, and a retrospective chart review was performed. We collected data on 2 main outcomes, recurrence-free survival (defined as a negative cystoscopy, cytology, and/or histology at the evaluation time point) and progression-free survival (defined as a negative cystoscopy or a nonprogressive tumor recurrence). <b><i>Results:</i></b> The NMIBC progression rate was higher in BCG than EMDA/MMC but not statistically significant (respectively, 4.2% vs. 2.5%; <i>p</i> = 0.703). In the overall population, the risk of NMIBC recurrence was higher after BCG than EMDA/MMC (<i>p</i> = 0.025). In the subgroups of 59 paired patients with similar characteristics, no difference was observed between groups in NMIBC progression and recurrence. <b><i>Conclusions:</i></b> Our findings suggest that EMDA/MMC and BCG are safe and reproducible approaches as adjuvant treatment in NMIBC. EMDA/MMC permits to achieve a fine oncological management as adjuvant treatment in NMIBC, which is not less than that obtained with BCG.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 294-294
Author(s):  
Andrew J. Lightfoot ◽  
Benjamin N. Breyer ◽  
Henry M. Rosevear ◽  
Badrinath Konety ◽  
Michael A. O'Donnell

294 Background: Combination chemotherapy is the standard of care for neoadjuvant, adjuvant, and metastatic bladder cancer due to increased efficacy when compared to monotherapy. We report our experience with sequential intravesical combination chemotherapy using gemcitabine and mitomycin C (MMC) for non-muscle invasive bladder cancer (NMIBC). Methods: We performed a multi-institutional retrospective review of 47 consecutive patients who received 6 weekly treatments with sequential gemcitabine (1g) and mitomycin C (40mg) chemotherapy for NMIBC. Thirty patients received treatment at University of Iowa, 14 at UCSF and 3 at University of Minnesota. Results: A total 47 patients (median age 70, range 32-85; 36 males, 11 females) previously failing a median of 2 intravesical treatments were reviewed. The complete response (CR), 1-year recurrence-free survival (1-RFS) and 2-year recurrence-free survival (2-RFS) for all patients was 68%, 48% and 38%, respectively. In all, 14 of 47 patients (30%) remain free of recurrence with a median time to followup of 26 months (range 6-80 months). The median time to recurrence for all patients who recurred was 4 months (range 1-33 months). Ten patients required cystectomy. Conclusions: Sequential intravesical combination chemotherapy using gemcitabine and MMC appears to be a useful treatment for patients with a history of NMIC which has failed BCG or other intravesical therapy, in addition to patients with intermediate and high-risk disease.


2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e15544-e15544
Author(s):  
Savino Mauro Di Stasi ◽  
Claus Riedl ◽  
Cristian Verri ◽  
Francesco Celestino ◽  
Francesco De Carlo ◽  
...  

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 369-369
Author(s):  
Paul Sargos ◽  
Igor Latorzeff ◽  
Aude Flechon ◽  
Guilhem Roubaud ◽  
Veronique Brouste ◽  
...  

369 Background: Radical cystectomy (RC) and pelvic lymph-node dissection (PLND) are standard procedures in the management of non-metastatic muscle invasive bladder cancer (MIBC). Loco-regional recurrence (LRR) is a common early event associated with a poor prognosis. The aim of this study is to evaluate adjuvant radiotherapy (RT) for pathological high-risk MIBC. Methods: We retrospectively reviewed data from patients treated by RC from 3 institutions. Inclusion criteria were MIBC, histologically proven urothelial carcinoma treated by RC and adjuvant RT. Patients with conservative surgery were excluded. LRR free-survival, overall survival (OS) and metastasis-free survival (MFS) were evaluated. Acute toxicities were recorded according to CTCAE V4.0 scale. Results: Between January 2000 and December 2013, 57 patients with a median age of 66 years (45-84) were included. Post-operative pathological staging was pT2, pT3 and pT4 in 16%, 44%, and 39%, respectively. PLND revealed 28% of pN0, 26% of pN1 and 42% of pN2. For 2 patients, no PLND was performed. Median number of lymph-nodes retrieved was 10 (2-33). Forty-eight patients (84%) received platin-based chemotherapy, 7 in neo-adjuvant and 41 in adjuvant setting. For RT, clinical target volume 1 (CTV 1) alwyas encompasses pelvic lymph nodes and cystectomy bed for 37 patients (65%). Median dose for CTV 1 was 45 Gy (4-50). Dose complement of 16 Gy (5-22) corresponding to CTV 2 was achieved in 53 of cases, depending on pathological features. Intensity Modulated RT was performed in one third of patients. With a median follow-up of 40.4 months, LRR occurred in 8 patients (14%). Three-year loco-regional free survival, MFS and OS were 45% (IC 95%: 0.30-0.60), 39% (IC 95%: 0.25-0.52) and 49% (IC 95%: 0.33-0.63), respectively. Acute grade ≥ 3 toxicities were observed in 5 patients (9%). One patient died with intestinal fistula in septic context. No survival or toxicity predictive factor was identified. Conclusions: Adjuvant radiotherapy for pathological high-risk MIBC is safe and may have oncological benefits. Thus, new prospective trials evaluating this approach with modern RT techniques should be undertaken.


PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e12248
Author(s):  
Chengyu You ◽  
Xianhui Li ◽  
Yuelin Du ◽  
Hui Wang ◽  
Xiaojun Zhang ◽  
...  

Background To summarize the current evidence on the effects of intra-arterial chemotherapy (IAC) on high-risk non-muscle invasive bladder cancer (NMIBC) and compare oncology results with intravesical chemotherapy (IVC). Methods We performed a systematic review and cumulative meta-analysis of the primary outcomes of interest by a systematical search of multiple scientific databases in February 2021. The mean difference (MD) and odds ratio (OR) were calculated for continuous and dichotomous variables respectively, with 95% confidence intervals (CIs). The hazard radio (HR) with 95% CIs was used for overall survival (OS), recurrence-free survival (RFS) and progression-free survival (PFS). Results A total of six studies with 866 patients were included. For IAC combined with IVC versus IVC alone, statistically significant differences were found regarding tumor recurrence rate (OR: 0.51, 95% CI [0.36∼0.72], p = 0.0001), tumor progression rate (OR: 0.47, 95% CI [0.30∼0.72], p = 0.0006), tumor-specific death rate (OR: 0.49, 95% CI [0.25∼0.99], p = 0.05), PFS (HR: 0.47, 95% CI [0.23∼0.96], p = 0.04) and RFS (HR: 0.60, 95% CI [0.41∼0.87], p = 0.007). No significant difference between two groups was found for time to first recurrence (MD: 3.27, 95% CI [−2.37∼8.92], p = 0.26) and OS (HR: 1.20, 95% CI [0.44∼3.32], p = 0.72). For IAC alone versus IVC, There was no statistical difference in the terms of tumor-specific death rate (OR: 0.67, 95% CI [0.29∼1.53], p = 0.34), RFS (HR: 0.90, 95% CI [0.56∼1.46], p = 0.68) and PFS (HR: 0.71, 95% CI [0.32∼1.55], p = 0.39). Adverse events mainly included nausea/vomiting (36.3%), hypoleukemia (19.4%), neutropenia (16.0%), increased creatinine (9.9%), increased alanine aminotransferase (18.7%), and thrombocytopenia (9.9%). Conclusion The IAC combined with IVC is a safe and effective treatment for high risk NMIBC, with lower rates of recurrence, progression, tumor-specific death, PFS and RFS, and with minor and tolerable events. The effectiveness of the IAC alone is parallel to the IVC alone.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Won Sik Ham ◽  
Jee Soo Park ◽  
Won Sik Jang ◽  
Young Deuk Choi ◽  
Jongchan Kim

AbstractThere is evidence that a history of benign prostatic hyperplasia increases the incidence of bladder cancer, and treatment with 5-alpha reductase inhibitor or androgen deprivation therapy reduces recurrence of non-muscle invasive bladder cancer. We aimed to evaluate whether prostate volume affects its prognosis. We reviewed medical records of men who underwent transurethral resection of bladder tumor due to non-muscle invasive bladder cancer from January 2012 to December 2017. Patients were divided into two groups based on prostate volume measured by computed tomography (group 1: 264 patients with ≤ 30 mL, group 2: 124 patients with > 30 mL). Propensity score matching analysis was used for adjust selection bias, and then assessed recurrence-free survival and progression-free survival. With a median follow up duration of 52 months, group 1 showed higher 5-year recurrence-free and progression-free survival (69.3% vs 47.0%, p = 0.001; 96.7% vs 87.7%, p = 0.002). Further, cox-regression analysis showed that tumor size (HR = 1.292 p < 0.001), multifocal tumor (HR = 1.993, p < 0.001), adjuvant intravesical therapy (chemotherapy: HR = 0.580, p = 0.037 and bacillus Calmette–Guérin: HR = 0.542, p = 0.004) and prostate volume (HR = 2.326, p < 0.001) were significant predictors of recurrence-free survival. Prostate volume (HR = 2.886, p = 0.014) was also associated with PFS with age (HR = 1.043, p = 0.044) and tumor grade (HR = 3.822, p = 0.013). We conclude higher prostate volume is associated with worse recurrence and progression-free survival in non-muscle invasive bladder cancer.


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