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An Individual Patient Data Meta-Analysis of the Long-Term Outcome of Randomised Studies Comparing Intravesical Mitomycin C versus Bacillus Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer
Open accessAbstract
BACKGROUND Patients with non-muscle-invasive bladder cancer with an intermediate or high risk need adjuvant intravesical therapy after surgery. Based largely on meta-analyses of previously published results, guidelines recommend using either bacillus Calmette-Guérin (BCG) or mitomycin C (MMC) in these patients. Individual patient data (IPD) meta-analyses, however, are the gold standard. OBJECTIVE To compare the efficacy of BCG and MMC based on an IPD meta-analysis of randomised trials. DESIGN, SETTING, AND PARTICIPANTS Trials were searched through Medline and review articles. The relevant trial investigators were contacted to provide IPD. MEASUREMENTS The drugs were compared with respect to time to recurrence, progression, and overall and cancer-specific death. RESULTS AND LIMITATIONS Nine trials that included 2820 patients were identified, and IPD were obtained from all of them. Patient characteristics were 71% primary, 54% Ta, 43% T1, 25% G1, 58% G2, and 16% G3, and 7% had prior intravesical chemotherapy. Based on a median follow-up of 4.4 yr, 43% recurred. Overall, there was no difference in the time to first recurrence (p=0.09) between BCG and MMC. In the trials with BCG maintenance, a 32% reduction in risk of recurrence on BCG compared to MMC was found (p<0.0001), while there was a 28% risk increase (p=0.006) for BCG in the trials without maintenance. BCG with maintenance was more effective than MMC in both patients previously treated and those not previously treated with chemotherapy. In the subset of 1880 patients for whom data on progression, survival, and cause of death were available, 12% progressed and 24% died, and, of those, 30% of the deaths were due to bladder cancer. No statistically significant differences were found for these long-term end points. CONCLUSIONS For prophylaxis of recurrence, maintenance BCG is required to demonstrate superiority to MMC. Prior intravesical chemotherapy was not a confounder. There were no statistically significant differences regarding progression, overall survival, and cancer-specific survival between the two treatments.
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CHALMERS, I. (1993) · Annals of the New York Academy of Sciences · doi:10.1111/j.1749-6632.1993.tb26345.x · Cited by 561
Cited by
Babjuk, M., Burger, M., Capoun, O., Cohen, D., Compérat, E. M., Dominguez Escrig, J. L., Gontero, P., Liedberg, F., Masson-Lecomte, A., Mostafid, A. H., et al. (2022) · European Urology · doi:10.1016/j.eururo.2021.08.010 · Cited by 1,615
Self-citationBabjuk, M., Burger, M., Compérat, E. M., Gontero, P., Mostafid, A. H., Palou, J., van Rhijn, B. W. G., Rouprêt, M., Shariat, S. F., Sylvester, R., et al. (2019) · European Urology · doi:10.1016/j.eururo.2019.08.016 · Cited by 1,297
Self-citationEAU Guidelines on Non–Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2013
Babjuk, M., Burger, M., Zigeuner, R., Shariat, S. F., van Rhijn, B. W. G., Compérat, E., Sylvester, R. J., Kaasinen, E., Böhle, A., Palou Redorta, J., et al. (2013) · European Urology · doi:10.1016/j.eururo.2013.06.003 · Cited by 1,174
Self-citationBladder cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Powles, T., Bellmunt, J., Comperat, E., De Santis, M., Huddart, R., Loriot, Y., Necchi, A., Valderrama, B. P., Ravaud, A., Shariat, S. F., et al. (2022) · Annals of Oncology · doi:10.1016/j.annonc.2021.11.012 · Cited by 555
Dyrskjøt, L., Hansel, D. E., Efstathiou, J. A., Knowles, M. A., Galsky, M. D., Teoh, J., & Theodorescu, D. (2023) · Nature Reviews Disease Primers · doi:10.1038/s41572-023-00468-9 · Cited by 544
Metadata
- Authors
- Malmström, P.-U., Sylvester, R. J., Crawford, D. E., Friedrich, M., Krege, S., Rintala, E., Solsona, E., Di Stasi, S. M., & Witjes, J. A.
- Venue
- European Urology
- Publisher
- Elsevier BV
- Published
- 2009-08
- Volume
- 56
- Issue
- 2
- Pages
- 247-256
- ISSN
- 0302-2838 (ISSN-L)
- OpenAlex
- W2134589781
- Cited by
- 662
- References
- 1
- FWCI
- 6.00
- Type
- journal article
- Language
- en
- Open access
- green
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- Malmström, P.-U., Sylvester, R. J., Crawford, D. E., Friedrich, M., Krege, S., Rintala, E., Solsona, E., Di Stasi, S. M., & Witjes, J. A. (2009). An Individual Patient Data Meta-Analysis of the Long-Term Outcome of Randomised Studies Comparing Intravesical Mitomycin C versus Bacillus Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer. European Urology. https://doi.org/10.1016/j.eururo.2009.04.038
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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