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Administration of Mycobacterium phlei cell wall-nucleic acid complex in the immediate postoperative period for the treatment of non-muscle-invasive bladder cancer.

ABSTRACT: INTRODUCTION:This review sought to investigate the safety of intravesical administration of Mycobacterium phlei cell wall-nucleic acid (MCNA) in the immediate postoperative period after biopsy/resection for non-muscle-invasive bladder cancer (NMIBC). METHODS:Patients with NMIBC who failed bacillus Calmette-Guérin (BCG) therapy and at high risk of recurrence and progression participated in this study. Treatment involved an induction phase of six weeks and maintenance of three weekly instillations every six months for two years. Biopsies were mandatory at six months and resections/biopsies as indicated. Of the 129 patients enrolled, 18 (14%) received one or more instillations of MCNA within 24 hours of an endoscopic procedure for a total of 32 instillations. RESULTS:Fourteen patients (78%) received MCNA in the immediate postoperative period. Two (11%) received treatment the day after surgery, but a second treatment immediately after a transurethral resection of the bladder tumour (TURBT). The remaining two patients received an instillation each the day after surgery. Adverse events (AEs) occurred in 31.3% of those treated immediately after the procedure; they were mild, limited to the lower urinary tract, and not drug-related. Only one patient experienced systemic symptoms of moderate severity. None of the AEs resulted in postponement of treatment. There were no AEs among those receiving MCNA the day after surgery. CONCLUSIONS:The dual mechanism of action of MCNA suggests that early treatment would take advantage of its chemotherapeutic (pro-apoptotic) activity. Concerns about early administration due to the presence of live bacteria are circumvented with this sterile preparation. These preliminary results warrant further investigation to confirm the safety of perioperative administration of MCNA.

SUBMITTER: Morales A

PROVIDER: S-EPMC5085912 | biostudies-literature | 2016 Sep-Oct

REPOSITORIES: biostudies-literature

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Administration of Mycobacterium phlei cell wall-nucleic acid complex in the immediate postoperative period for the treatment of non-muscle-invasive bladder cancer.

Morales Álvaro Á

Canadian Urological Association journal = Journal de l'Association des urologues du Canada 20160901 9-10

<h4>Introduction</h4>This review sought to investigate the safety of intravesical administration of Mycobacterium phlei cell wall-nucleic acid (MCNA) in the immediate postoperative period after biopsy/resection for non-muscle-invasive bladder cancer (NMIBC).<h4>Methods</h4>Patients with NMIBC who failed bacillus Calmette-Guérin (BCG) therapy and at high risk of recurrence and progression participated in this study. Treatment involved an induction phase of six weeks and maintenance of three weekl ...[more]

PMID: 27800054

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Project description:Background: We have previously reported the results of a prospective multi-institutional study on the efficacy of MCNA in patients who recurred after intravesical BCG treatment [1]. Since that publication, a new standardized definition for BCG-unresponsiveness has been established [2]. Objective: We re-analyzed the oncologic outcomes following intravesical MCNA in patients classified as BCG-unresponsive according to the new definition. Methods: For this analysis, we focused on the enrolled patients who satisfied the requirements for BCG Unresponsiveness: i.e. adequate BCG treatment (at least 5/6 induction and 2/3 maintenance instillations) and high grade tumor within 6 months of prior BCG. Treatment course included 6 weekly intravesical instillations of 8 mg MCNA followed by 3 weekly instillations at months 3, 6, 12, 18, and 24. Followup assessments included cystoscopy, urine cytology and biopsy. Patients absent of high grade disease confirmed by central review of biopsy were deemed disease-free. Results: Of the 129 patients enrolled, 94 (68 CIS with/without papillary tumors, 26 papillary only tumors) fit the criteria for the new BCG Unresponsive definition. Overall, disease free survival (DFS) for all BCG unresponsive patients was 48.9% (95% CI 38.0-59.0%) at 6 months, 34.8% (95% CI 24.7-45%) at 1 year and 28.3% (15.7-34.3%) at 2 years post induction. In the group with papillary tumors, DFS measured at months 6, 12, and 24 were: 61.2% (38.2-77.8%), 61.2(38.2-77.8%), and 50.1% (27.5-69%). In the CIS-containing group, the corresponding DFS were: 44.8% (32.3-56.4%), 26.5% (16.3-37.9%), and 16.6% (8.6-26.9%), respectively. Conclusions: For patients who are BCG Unresponsive, MCNA has the potential to render 26.5% of patients with CIS and 61.2% of patients with papillary tumors disease-free for at least 1 year with an intact bladder. The higher efficacy noted in the true BCG-unresponsive cohort than was previously reported with all-comers emphasizes the importance of having clearly defined criteria for clinical trials investigating new intravesical therapies after BCG failure.

Project description:BackgroundBladder cancer imposes a significant public health burden on the European Union. There is a need for cost-effective treatment and follow-up regimens.ObjectiveTo assess the cost-effectiveness of immediate mitomycin C (MMC) instillation within 1 d after surgery compared to delayed MMC instillation within 2 wk after surgery with further adjuvant treatment, depending on the patient's risk group.Design setting and participantsThis economic evaluation was based on a randomized controlled trial among 2243 Dutch patients with non-muscle-invasive bladder cancer (NMIBC) patients from a health care perspective over a 3-yr time period.Outcome measurements and statistical analysisThe treatment effect was measured as time to recurrence and recurrence-free survival. Missing effect data were imputed with multiple imputation. Health care utilization and related costs were estimated on the basis of treatment protocols for NMIBC patients in the Netherlands. Statistical uncertainty was estimated using bootstrapping and is graphically presented using cost-effectiveness planes and cost-effectiveness acceptability curves.Results and limitationsTime to recurrence was significantly longer for immediate MMC instillation (27.31 mo) than for delayed MMC instillation (24.97 mo), with an adjusted mean difference of 2.21 mo (95% confidence interval [CI] 1.58-2.84). The proportion of patients with recurrence-free survival was significantly higher after immediate MMC instillation (0.65) than after delayed MMC instillation (0.56), with an adjusted mean difference of 0.08 (95% CI 0.06-0.11). Total mean health care costs per patient were significantly lower for immediate MMC instillation (€22 959) than for delayed MMC instillation (€24 624), with an adjusted mean difference of -€1350 (95% CI -€1799 to -€900). The study is limited by the retrospective estimation of costs.ConclusionsThis trial-based cost-effectiveness analysis shows that from a health care perspective, immediate MMC instillation is more effective and less expensive compared to delayed MMC instillation.Patient summaryWe assessed the cost-effectiveness of immediate bladder instillation of mitomycin C after surgery to reduce the risk of recurrence after removal of the bladder tumor as compared to delayed instillation in a large Dutch population of patients with non-muscle-invasive bladder cancer. We found that immediate instillation was more effective and less expensive than delayed instillation. We conclude that immediate mitomycin C instillation is a cost-effective treatment for non-muscle-invasive bladder cancer.

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Administration of Mycobacterium phlei cell wall-nucleic acid complex in the immediate postoperative period for the treatment of non-muscle-invasive bladder cancer.

Publications

Administration of Mycobacterium phlei cell wall-nucleic acid complex in the immediate postoperative period for the treatment of non-muscle-invasive bladder cancer.

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