Bacillus Calmette-Guérin versus mitomycin intravesical therapy in superficial bladder cancer

Debruyne, F. M. J.; Meijden, P.M. van der; Witjes, J. Alfred; Franssen, M.P.H.; Steerenberg, P. A.; DeJong, W.H.; Read, John; Leeuwen, M.J.W. van; Hammond, B; Sylvester, Richard

doi:10.1016/0090-4295(92)90530-a

Cited by 17 publications

(6 citation statements)

References 12 publications

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“…The question of whether adjuvant instillation therapy with BCG is superior to intravesical chemotherapy at preventing tumor recurrence is somewhat controversial and has been addressed in several prospective randomized studies. Although the results are conflicting, BCG was reported to be superior to chemotherapy in the majority of these studies (61)(62)(63)(64)(65)(66)(67). The long-term effects regarding progression still remain uncertain.…”

Section: Methods Of Treatmentmentioning

confidence: 94%

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Wijkström

Cohen

Gardiner

et al. 2000

Scandinavian Journal of Urology and Nephrology

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Bladder cancer is believed to develop through reversible premalignant stages followed by irreversible steps, and ending in invasive cancer giving rise to distant metastases. Because of the variation in the clinical course it has also been suggested that different forms of cancer develop along different molecular pathways leading to tumor presentations of various malignant potential. Today we treat and prognosticate bladder cancer on the basis of clinical and histologic findings that are insufficient to assess all the biologic potential of these tumors. Understanding the pathogenesis of bladder cancer might lead to a more precise identification of particular tumors with regard to clinical aggressiveness, resulting in individualized strategies for treatment and prophylaxis.Bladder cancer is seldom diagnosed in its preclinical stage, it is instead detected at cystoscopy and virtually never recognized as an incidental finding on autopsy. Therefore its "natural history" largely reflects that of "treated" disease. The true incidence of premalignant and malignant epithelial changes is not known. Incidences of hyperplasia and dysplasia of %10% and %5%, respectively and only occasional findings of cancer itself were reported in two autopsy series. Urothelial dysplasia is generally believed to be premalignant and a putative precursor of invasive cancer but unfortunately there has been a lack of standardization in terms of terminology and diagnosis. There is also a need for an agreed definition of the boundary between premalignancy, i.e. urothelial changes that have some but not all the features of carcinoma in situ, and malignancy, especially when considering potentially harmful treatments to prevent this transition. Most new diagnostic tools available and being tested today compare new detection techniques with traditional methods such as cytology or conventional histology of malignant rather than premalignant changes. There is probably also a short preclinical latency, as implied by the incidental findings of bladder cancer at autopsy, which makes it necessary to define how and when to promote early detection and treatment.Future studies therefore have to concentrate on methods for early detection of disease as well as characterization of host susceptibility, evaluation of exposure to carcinogens and potential effects of preventive measures. It is also likely that the improved tools of molecular prognostication will allow us to design trials more precisely in order to tailor therapeutic strategies.

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Section: Methods Of Treatmentmentioning

confidence: 94%

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Wijkström

Cohen

Gardiner

et al. 2000

Scandinavian Journal of Urology and Nephrology

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“…Potential Confounding Effects on Treatment Efficacy Concerning Tumor Recurrence: The results from studies using different BCG strains, that is Pasteur (3 studies), Connaught (4), Tice (1), RIVM (1), RIVM plus Tice (1) and Danish SSI-1331 (1), differed significantly (Kruskal-Wallis-ANOVA p ϭ 0.023) mainly due to lower relative efficacy of BCG versus mitomycin C (higher OR) in 2 studies without BCG maintenance using BCG strain RIVM, 10 or RIVM plus Tice, respectively. 11 The latter study delivered much weaker efficacy results for BCG compared to mitomycin C than any other study included in our analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Lines indicate 95% CI, squares OR estimates, whereas square size is proportional to sample size, and rhombs meta-analytically pooled OR estimates Ϯ95% CI. MMC, mitomycin C. 10 Krege et al 23 Lamm et al 12 Lundholm et al 13 Vegt et al 11 …”

Section: Recurrence and Toxicity Of Intravesical Bacillus Calmette-gumentioning

confidence: 99%

Intravesical Bacillus Calmette-Guerin Versus Mitomycin C For Superficial Bladder Cancer: A Formal Meta-Analysis of Comparative Studies on Recurrence and Toxicity

2003

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Purpose: We compare the therapeutic efficacy and toxicity of intravesical bacillus CalmetteGuerin (BCG) with mitomycin C on recurrence of stages Ta and T1 bladder carcinoma.Materials and Methods: Combined published and unpublished data from comparative studies on BCG versus mitomycin C for superficial bladder carcinoma considering possible confounding factors were analyzed. Odds ratio (OR) and its 95% CI were used as primary effect size estimate. Toxicity data were evaluated descriptively.Results: In 11 eligible clinical trials 1,421 patients were treated with BCG and 1,328 were treated with mitomycin C. Within the overall median followup time of 26 months 38.6% of the patients in the BCG group and 46.4% of those in the mitomycin C group had tumor recurrence. In 7 of 11 studies BCG was significantly superior to mitomycin C, in 3 studies no significant difference was found, while in 1 study mitomycin C was significantly superior to BCG. An overall statistically significant superiority of BCG versus mitomycin C efficacy in reducing tumor recurrence was detected (OR 0.56, 95% CI 0.38 to 0.84, p ϭ 0.005). In the subgroup treated with BCG maintenance all 6 individual studies showed a significant superiority of BCG over mitomycin C (OR 0.43, 95% CI 0.35 to 0.53, p Ͻ0.001). In 4 of the 5 studies with reported data on toxicity BCG associated cystitis was significantly more frequent than in the mitomycin C group (53.8% versus 39.2%). The combined cystitis OR was 1.81 (95% CI 1.48 to 2.23, p Ͻ0.001). The OR for cystitis in the BCG maintenance group did not significantly differ from that in the nonmaintenance therapy group.Conclusions: The results suggest superiority of BCG over mitomycin C for prevention of tumor recurrences in the combined data and particularly in the BCG maintenance treatment subgroup, irrespective of the actual (intermediate or high) tumor risk status. The toxicity with BCG is higher but does not differ between BCG maintenance and nonmaintenance groups.KEY WORDS: bladder neoplasms; administration, intravesical, mitomycin, meta-analysis, recurrenceThe primary treatment of bladder cancer is transurethral resection but up to 70% of superficial tumors recur. Adjuvant intravesical instillation against tumor recurrences with chemotherapy or immunotherapy is well established. Among the chemotherapeutic agents mitomycin C was effective compared with transurethral resection in some but not all studies. [1][2][3] The most important immunotherapeutic agent against bladder cancer recurrences is bacillus Calmette-Guerin (BCG). In randomized clinical trials comparing adjuvant BCG with transurethral resection only BCG showed a superior efficacy against tumor recurrences. However, in direct comparative studies of BCG versus mitomycin C the results remain controversial with proved BCG superiority in some but not all studies. 4 We analyzed combined published and unpublished data from comparative clinical trials and cohort studies on BCG versus mitomycin C considering possible confounding factors such as maintena...

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“…[ 101A more frequent adverse effect is chemical cystitis, which is seen in approx imately 15% of patients.10^ In our series, druginduced cystitis and (culture proven) bacterial cys titis were seen in 20 to 25% of the patients. [22,23] Allergic reactions, mainly skin reactions such as palmar rash, are found in approximately 10%J10,241 Most adverse effects disappear after cessation of therapy.…”

Section: Mitomycinmentioning

confidence: 99%

Current Recommendations for the Management of Bladder Cancer

Witjes

1997

Drugs

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Bacillus Calmette-Guérin versus mitomycin intravesical therapy in superficial bladder cancer

Cited by 17 publications

References 12 publications

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Intravesical Bacillus Calmette-Guerin Versus Mitomycin C For Superficial Bladder Cancer: A Formal Meta-Analysis of Comparative Studies on Recurrence and Toxicity

Current Recommendations for the Management of Bladder Cancer

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