Guidelines for the Management of Non-Muscle Invasive Bladder Cancer (Stages Ta, T1, and TIS): 2007 Update
American Urological Association Education and Research, Inc., USA. The Journal of urology
(Impact Factor: 4.47).
01/2008; 178(6):2314-30. DOI: 10.1016/j.juro.2007.09.003
Available from: Vignesh Packiam
- "However, the most important outcome to consider when assessing adjuvant second-line intravesical therapies is disease progression. Patients failing MCNA had a 12% yearly progression rate to muscle-invasive disease, which was similar to previously cited rates for those with BCG failure [Hall et al. 2007]. This suggests that failure of a course of MCNA does not increase the risk of progression. "
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The treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) utilizes transurethral resection followed by adjuvant intravesical immunotherapy or chemotherapy. Intravesical bacillus Calmette-Guérin (BCG) is the mainstay of adjuvant immunotherapy, but there are limited nonsurgical options for patients that fail this treatment. Mycobacterial cell wall nucleic acid complex (MCNA) is an immunotherapeutic agent utilized primarily after failure of intravesical BCG. The purpose of this paper is to provide a comprehensive review of the published literature regarding MCNA.
A literature review was performed and identified studies indexed in MEDLINE(®) related to utilization of MCNA for patients with NMIBC.
Two trials assessed the efficacy of MCNA in patients with NMIBC, comprising a total of 184 patients. Most patients had carcinoma in situ (CIS) with (26%) or without (52%) concomitant papillary tumors. A minority of patients had only papillary tumors (22%). Most patients (95%) previously received BCG or other intravesical therapy prior to receiving MCNA. In the largest available trial, 25% and 19% of patients had no evidence of residual cancer in 1 and 2 years following initiation of MCNA. A total of 2.3% of patients had adverse events (AEs) leading to delay or discontinuation of therapy and 66% of patients had mild drug-related AEs.
Based on analysis of available published data, MCNA offers a durable response for a small proportion of patients that have failed prior intravesical therapy. There still exists a large unmet need for nonsurgical treatment options for patients with NMIBC who have failed adjuvant intravesical therapies.
Available from: Michael A. O’Donnell
- "In the event of BCG failure, the preferred treatment for high-risk patients per EAU and AUA guidelines is to proceed with cystectomy  . However, some patients have a strong preference for bladder preservation or are poor surgical candidates, making alternative intravesical salvage therapies essential for this cohort. "
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ABSTRACT: Background: Bacillus Calmette-Guerin (BCG) is the most effective intravesical therapy for non-muscle invasive bladder cancer
(NMIBC), but patients can fail or supply shortages can develop. For BCG failures, radical cystectomy is recommended. However,
in patients who desire bladder preservation or are poor surgical candidates, alternative salvage intravesical therapies should be
Objective: To determine whether dual sequential intravesical gemcitabine and docetaxel is effective in treating NMIBC.
Methods: We evaluated our initial experience with 45 patients treated with intravesical gemcitabine and docetaxel between
June 2009 and May 2014. Patients were treated with 6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of
sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline). Treatment success was defined as
no bladder cancer recurrence and no cystectomy. Intention-to-treat analysis was performed using the Kaplan Meier method.
Results: Forty-five patients received treatment with a median overall follow-up of 15 months. Median follow up for treatment
success was 6 months in all patients and 13 months for responders. Five patients were unable to tolerate a full induction course.
Treatment success was 66% at first surveillance, 54% at 1 year, and 34% at 2 years after initiating induction. Ten patients received
cystectomy (median of 5.6 months from starting induction) with no positive margins or lymph nodes on final pathology.
Conclusions: Sequential dual intravesical gemcitabine and docetaxel can salvage some patients in a challenging NMIBC cohort
- "PDD by transurethral administration of HAL was approved for bladder cancer in Europe in 2005 and the US in 2010, and is now clinically used in many countries. Various recommendations of PDD with transurethral HAL (HAL-PDD) for bladder cancer are described in the guidelines established by the European Association of Urology  and American Urological Association . In PDD of bladder cancer, HAL and 5-ALA as photosensitive substances to be transurethrally administered have shown the similar effectiveness with regards to diagnostic accuracy and recurrence prognosis . "
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ABSTRACT: Photodynamic diagnosis (PDD) of non-muscle-invasive bladder cancer (NMIBC) following transurethral administration of a hexalated form of 5-aminolevulinic acid (5-ALA), 5-ALA hexyl ester, is widely performed in Western countries. In this study, effectiveness and safety of the oral administration of 5-ALA is assessed in a phase II/III study of PDD for NMIBC in comparison to those of conventional white-light endoscopic diagnosis.
Patients with NMIBC were allocated to 2 groups that were orally administered 10 and 20mg/kg of 5-ALA under the double-blind condition. Effectiveness was evaluated by setting the primary endpoint to sensitivity. Safety was also analyzed. Moreover, clinically recommended doses of 5-ALA was also investigated as an investigator-initiated multicenter cooperative clinical trial in which 5 medical institutions participated.
All 62 enrolled patients completed the clinical trial. The sensitivities of PDD were higher(84.4 and 75.8% in the 10 and 20mg/kg-groups, respectively) than those of conventional endoscopic diagnosis (67.5 and 47.6%, respectively) (p=0.014 and p<0.001, respectively). Five episodes of serious adverse events developed in 4 patients; whereas a causal relationship with the investigational agent was ruled out in all episodes.
This investigator-initiated clinical trial confirmed the effectiveness and safety of PDD for NMIBC following oral administration of 5-ALA. Both doses of 5-ALA may be clinically applicable; however, the rate of detecting tumors only by PDD was higher in the 20mg/kg-group suggesting that this dose would be more useful.
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