Prospective phase II trial of alternating intravesical Bacillus Calmette-Gu�rin (BCG) and Interferon alpha IIB in the treatment and prevention of superficial transitional cell carcinoma of the urinary bladder: Preliminary results

Bazarbashi, Shouki; Raja, M. A.; Sayed, Amer; Ezzat, Adnan; Ibrahim, Ezzeldin M.; Kattan, Said; Kardar, Abdul Hafeez; Peracha, Amjad; Lindstedt, E; Hanash, Kamal A.

doi:10.1002/1096-9098(200007)74:3<181::aid-jso3>3.0.co;2-f

Cited by 10 publications

(3 citation statements)

References 16 publications

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“…The final number of papers included in the meta-analysis was 30, list of studies excluded and reasons were shown in Figure 1. Of these, nine were identified to explore the necessity of BCG maintenance [16-24], seven investigate the efficacy of low-dose BCG [5-7,25-28], and the remainders address the effects of BCG combination therapy [29-42]. There were 21 randomized-controlled trails (RCTs), eight retrospective studies and one case-series study.…”

Section: Resultsmentioning

confidence: 99%

“…The severe side-effects that can be easily recognized by both patients and researchers made most of studies failed to use double-blind method, which should be responsible for the low-quality of included RCTs. Only 1 retrospective studies which didn’t adopt appropriate protocol for treatment assignment and used historical series as controls were recognized as low quality case-series study (level of evidence: 4) [42]. The results of quality assessment were listed in Additional file 1: Table S2 and Table S3.…”

Section: Resultsmentioning

confidence: 99%

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Optimal schedule of bacillus calmette-guerin for non-muscle-invasive bladder cancer: a meta-analysis of comparative studies

Zhu

Tang

et al. 2013

BMC Cancer

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BackgroundTo explore the necessity of maintenance, efficacy of low-dose and superiority of various combination therapies of Bacillus Calmette-Guérin (BCG) in treatment of superficial bladder cancer (BCa).MethodsComprehensive searches of electronic databases (PubMed, Embase, and the Cochrane Library) were performed, then a systematic review and cumulative meta-analysis of 21 randomized controlled trials (RCTs) and 9 retrospective comparative studies were carried out according to predefined inclusion criteria.ResultsSignificantly better recurrence-free survivals (RFS) were observed respectively in patients who received BCG maintenance, standard-dose and BCG plus epirubicin therapy comparing to those received induction, low-dose and BCG alone. BCG maintenance therapy was also associated with significantly better progression-free survival (PFS), but there were more incidences of adverse events. Pooled results showed no remarkable advantage of BCG combined with Mitomycin C or with interferon α-2b in improving oncologic outcomes. Sensitivity-analyses stratified by study-design and tumor stage led to very similar overall results and often to a decrease of the between-study heterogeneity. Our data confirmed that non-RCT only affected strength rather than direction of the overall results.ConclusionsAll patients with superficial BCa should be encouraged to accept BCG maintenance therapy with standard-dose if well tolerated. Patients can benefit from BCG combined with epirubicin but not from BCG combined with Mitomycin C or interferon α-2b.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Optimal schedule of bacillus calmette-guerin for non-muscle-invasive bladder cancer: a meta-analysis of comparative studies

Zhu

Tang

et al. 2013

BMC Cancer

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“…This includes maintenance BCG therapy, combining BCG with other agents such as interferon and the use of other chemotherapeutic agents instead of BCG. We have previously published the result of two investigational approaches to reduce NMIBC recurrence after BCG therapy by either alternating intravesical BCG with interferon on a weekly basis[ 8 ] or combining BCG and Interferon. [ 9 ] Compared to published literature, our results were similar to the results obtained with BCG alone.…”

Section: Introductionmentioning

confidence: 99%

Recurrence and progression in nonmuscle invasive transitional cell carcinoma of urinary bladder treated with intravesical Bacillus Calmette–Guerin: A single center experience and analysis of prognostic factors

et al. 2016

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Background:Intravesical Bacillus Calmette–Guerin (BCG) has been the standard of care for the prevention of nonmuscle invasive bladder cancer (NMIBC) recurrence following resection. Attempts to improve on the result by combining it with other agents have largely failed. This study addresses the result of BCG therapy in our patient population and compares the result with our combination BCG and interferon therapy published earlier.Materials and Methods:The medical records of patients diagnosed with NMIBC and treated with transurethral resection and intravesical BCG were reviewed. Univariate analysis was performed on most known prognostic factors. Results were compared to published data on the use of BCG and interferon from the same institution.Results:Thirty-one patients were identified. Median age was 66 (range 33–109), 80.6% were males. Fourteen patients (45%) had ≤ 3 tumors and 18 (58.1%) had T1 lesions. Four patients (12.9%) had Grade 3 tumors and 25 (80.6%) had Grade 2 tumors. One patient (3.2) had concurrent carcinoma in situ and 11 (35.5%) were treated upon initial diagnosis. At 5 years, the relapse-free survival was 61.3% (95% confidence interval (CI) 44.2–78.4%), progression-free survival was 85.6% (95% CI 73.3–97.9%), and overall survival was 93% (95% CI 84.1–100%). Comparison with the BCG and interferon data showed no significant difference.Conclusion:The result of BCG therapy in our patient population is similar to western reported data. Efficacy of BCG alone is equal to BCG and interferon within our institution.

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Intravesical Bacillus Calmette-Guérin with interferon-alpha versus intravesical Bacillus Calmette-Guérin for treating non-muscle-invasive bladder cancer

Shepherd

Brook

2017

Cochrane Database of Systematic Reviews

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We found low- to very low-quality evidence suggesting no clear differences in recurrence or progression with BCG plus IFN-α compared with BCG alone for people with NMIBC; there was no information to determine the effect on discontinuation of therapy due to adverse events. Low-quality evidence suggests BCG alternating with IFN-α compared with BCG alone may increase time-to-recurrence, however low-quality evidence also suggests no clear differences for time-to-progression or discontinuation of therapy due to adverse events.Additional high-quality, adequately powered trials using standardised instillation regimens and doses of both BCG and IFN-α, reporting outcomes in subgroups stratified by patient and tumour characteristics, and on long-term outcomes related not only to recurrence but also to progression, discontinuation due to adverse events, and mortality may help to clarify the ideal treatment strategy and provide a more definitive result.

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Prospective phase II trial of alternating intravesical Bacillus Calmette-Gu�rin (BCG) and Interferon alpha IIB in the treatment and prevention of superficial transitional cell carcinoma of the urinary bladder: Preliminary results

Abstract: Alternating intravesical BCG and IFN is effective and well tolerated therapy for superficial TCC of urinary bladder.

Cited by 10 publications

References 16 publications

Optimal schedule of bacillus calmette-guerin for non-muscle-invasive bladder cancer: a meta-analysis of comparative studies

Optimal schedule of bacillus calmette-guerin for non-muscle-invasive bladder cancer: a meta-analysis of comparative studies

Recurrence and progression in nonmuscle invasive transitional cell carcinoma of urinary bladder treated with intravesical Bacillus Calmette–Guerin: A single center experience and analysis of prognostic factors

Intravesical Bacillus Calmette-Guérin with interferon-alpha versus intravesical Bacillus Calmette-Guérin for treating non-muscle-invasive bladder cancer

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