A multicenter and randomised prospective study comparing three intravesical therapies, two with bacillus calmette-guerin inmunotherapy and one with mitomicyn-C chemotherapy in medium and low risk superficial bladder tumours

March, N.; Narbon, S.; Urzaiz, U.; Calvo, Ovidio Fernández; Molina, R.; Gomez, F.; Martin, Grace; González, Claudia; Piñeiro, Marta

doi:10.1016/s1569-9056(03)80752-2

Cited by 3 publications

(6 citation statements)

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“…The incidence of bladder retraction in the RD arm was 0.4%; the previous probability estimate [23] was 5 (2-5)%. Also, the present rate of overall systemic side-effects in the RD arm was lower than that reported previously [23], at 15.4% and 23 (19)(20)(21)(22)(23)(24)(25)(26)(27))%, respectively. Nevertheless, there is no consensus about a direct relationship between dosage and toxicity, but some contend that the schedule and number of instillations are the most important [24].…”

Section: Discussioncontrasting

confidence: 73%

“…As such low-dose therapy was felt to warrant a randomized study, the CUETO Group began another trial in 1995 (95011) to compare low-and intermediate-risk tumours treated with 13.5 mg BCG (Connaught strain), 27 mg BCG or mitomycin C (30 mg); the interim analysis at 20 months medium follow-up [19] showed better efficacy for both BCG doses against recurrences (P=0.055) and a longer disease-free interval in patients treated with BCG (P=0.046). Local and systemic toxicity was significantly higher in both BCG groups than with mitomycin C but there were no differences between the BCG arms.…”

Section: Discussionmentioning

confidence: 99%

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Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

̃eiro¹,

Flores²,

Isorna³

et al. 2002

BJU International

194

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Objectives To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille CalmetteGuérin (BCG) against the standard dose (81 mg) in patients with superficial bladder cancer, assessing recurrence, progression and differences in toxicity. Patients and methods Five hundred patients with superficial bladder cancer (Ta, T1, Tis) were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG Connaught strain (weeklyrsix and thereafter fortnightlyrsix) either with the standard or RD instillation. Results All but one of the 500 patients were evaluable for efficacy and toxicity (252 in the standard arm and 247 in the RD arm). The median follow-up was 69 months (maximum 104); 71 (28%) patients in the standard arm and 76 (31%) in the RD arm developed recurrences; the median time to recurrence has not yet been attained, but at 5 years the mean (SD) percentage of recurrence-free patients was 70.5 (3.12) and 70.4 (3.1) for the standard and RD arms, respectively. In patients presenting with multifocal tumours, the standard dose was more effective against recurrences than the RD (P=0.0151). In those with G3 and high-risk tumours overall, the superiority of the standard dose was marginal (P=0.060 and P=0.082). Twenty-nine (11.5%) tumours in the standard arm and 33 (13.3%) in the RD arm progressed to invasive disease; the median time to progression has not yet been attained, but the percentage of progression-free patients at 5 years was 88.8 (2.23) and 86.9 (2.31) for the standard and RD arms, respectively. The standard dose was more effective than the RD against progression only in patients with multifocal disease (P=0.048). Twelve (4.8%) cystectomies were performed in the standard and 15 (6.1%) in the RD arm. Currently, 106 (21.2%) patients have died, but only 38 (7.6%) from bladder cancer, i.e. 20 (7.9%) in the standard and 18 (7.5%) in RD arm. Overall the disease-specific death rate was lower for those patients who completed the scheduled treatment. The cause-specific survival at 5 years did not differ between the arms (P=0.76) but there was a trend toward better cause-specific survival for patients with multifocal tumours in the standard arm. Toxicity differed between the arms, significantly more patients having no toxicity in the RD arm, and fewer having delayed instillations or withdrawing. However, severe systemic toxicity occurred even in patients treated with the RD, in a similar proportion to those receiving the standard dose. Conclusion Overall, the RD gave similar results for recurrence and progression but with significantly less toxicity. However, patients with multifocal tumours fared better with the standard dose and there was a trend towards better recurrence rates in patients with highrisk tumours. We recommend continuing to use the standard dose for high-risk tumours, while we consider the reduced dose safe and effective for intermediaterisk lesions and for maintenance schedules.

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Section: Discussioncontrasting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

̃eiro¹,

Flores²,

Isorna³

et al. 2002

BJU International

194

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“…Fourteen articles were excluded as repeat publications, and four further articles comparing mitomycin C with an alternating regimen of BCG and mitomycin C and were also excluded. The remaining reports of seven different randomized trials comparing intravesical BCG with mitomycin C were considered for assessment [18][19][20][21][22][23][24].…”

Section: Resultsmentioning

confidence: 99%

“…For some patients data were missing or unavailable, so that altogether 1901 patients were evaluable for the present review. One trial [24] was in abstract form only and had insufficient data to accurately determine the LHR. Therefore only six of the seven trials were used for the pooled meta-analysis, representing 1527 patients; 693 randomized to mitomycin C and 834 to BCG.…”

Section: Resultsmentioning

confidence: 99%

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Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

et al. 2004

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OBJECTIVETo assess, in a systematic review and meta-analysis, the relative effectiveness of intravesical mitomycin C and bacillus Calmette-Guérin (BCG) for tumour recurrence, disease progression and overall survival in patients with medium-to high-risk Ta and T1 bladder cancer. METHODSThe major medical databases were searched comprehensively up to June 2003, and relevant journals hand-searched for randomized controlled trials, in any language, that compared intravesical mitomycin C with BCG in medium-to high-risk patients with Ta or T1 bladder cancer. RESULTSTwenty-five articles were identified but only seven were considered eligible for the analysis. This represented 1901 evaluable patients in all, 820 randomized to mitomycin C and 1081 to BCG. Six trials had sufficient data for meta-analysis and included 1527 patients, 693 in the mitomycin and 834 in the BCG arm. There was no significant difference between mitomycin C and BCG for tumour recurrence in the six trials, with a weighted mean log hazard ratio, LHR, (variance) of -0.022 (0.005). However, there was significant heterogeneity between trials ( P = 0.001). A subgroup analysis of three trials that included only high-risk Ta and T1 patients indicated no heterogeneity ( P = 0.25) and a LHR for recurrence of -0.371 (0.012). With mitomycin C used as the control in the meta-analysis, a negative ratio is in favour of BCG and, in this case, was highly significant ( P < 0.001). The seventh trial (in abstract form only) used BCG in low doses for two arms of the trial (27 mg and 13.5 mg) compared with a standard dose of mitomycin C (30 mg), and reported a significantly lower recurrence rate with BCG (27 mg) than for mitomycin C ( P = 0.001). Only two trials included sufficient data to analyse disease progression and survival, representing 681 patients (338 randomized to BCG and 343 to mitomycin C). There was no significant difference between mitomycin C and BCG for disease progression, with a LHR of 0.044 (0.04) ( P = 0.16), or survival, at -0.112 (0.03) ( P = 0.50). Adverse events were slightly more frequent with BCG. Local toxicity (dysuria, cystitis, frequency and haematuria) were associated with both mitomycin C (30%) and BCG (44%). SystemicThe first paper in this section is a meta-analysis of randomized trials into the effect of two intravesical agents used to reduce tumour recurrence in high-risk superficial bladder cancer. This is the highest level of evidence-based medicine and the results presented here suggest that intravesical BCG is superior to mitomycin C. There was no difference in the effect of the two agents on disease progression or survival. In a study from Amsterdam and Rome, the authors describe a phase I trial into the toxicity and safety of intravesical gemcitabine, and found that it was well tolerated with no systemic toxicity.In a paper from Taiwan the link between viral infections and tumour foundation is evaluated, in this case specifically infections with the Epstein-Barr virus and its correlation with urothelial cancer. The authors found ...

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Assessing the Feasibility of Replacing Standard-Dose Bacillus Calmette–Guérin Immunotherapy with Other Intravesical Instillation Therapies in Bladder Cancer Patients: A Network Meta-Analysis

Wu¹,

Xingqin²,

Miao³

et al. 2017

Cell Physiol Biochem

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Background: Bacillus Calmette–Guérin (BCG) immunotherapy plays a key role in patients with bladder cancer. The shortage of intravesical BCG has motivated researchers to seek alternatives with equivalent efficacy If other alternative intravesical agents have equivalent efficacy compared to BCG, then it may be feasible to replace standard BCG with alternative options. Methods: We searched all relevant evidence in multiple sources and key data was extracted from included studies. Conventional and network meta-analysis were conducted so that pooled odds ratios (ORs) for the event of tumor recurrence and progression can be computed. The relative efficacy of different intravesical instillation procedures was computed by pooled odds ratios and their 95% confidence or creditable intervals. Besides, several key model assumptions were evaluated in our analysis. Results: Three intravesical instillation procedures have the potential for preventing tumor recurrence: standard-dose BCG (BCG_SD), Epirubicin (EPI) and Mitomycin C (MMC) (ORs < 1). Patients with BCG SD also exhibited a decreased risk of tumor recurrence and progression compared to those with EPI. No significant difference in the risk of tumor recurrence or progression was detected between patients treated with BCG_ SD and those with low-dose BCG (BCG_LD). Results of SUCRA indicated that BCG_EPI, BCG_ MMC and BCG SD had higher rankings with respect to tumor recurrence and progression. Conclusions: BCG SD, EPI and MMC exhibited established efficacy for preventing tumor recurrence in postoperative BC patients. The efficacy of BCG may not be significantly reduced if standard dose was reduced to a lower level. However, there is no consensus suggesting that intravesical BCG with standard dose can be replaced by alternating or sequentially combined intravesical instillation therapies.

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A multicenter and randomised prospective study comparing three intravesical therapies, two with bacillus calmette-guerin inmunotherapy and one with mitomicyn-C chemotherapy in medium and low risk superficial bladder tumours

Cited by 3 publications

References 0 publications

Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

Assessing the Feasibility of Replacing Standard-Dose Bacillus Calmette–Guérin Immunotherapy with Other Intravesical Instillation Therapies in Bladder Cancer Patients: A Network Meta-Analysis

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