Long-term follow-up of an EORTC randomized prospective trial comparing intravesical bacille Calmette-Guérin-RIVM and mitomycin C in superficial bladder cancer. EORTC GU Group and the Dutch South East Cooperative Urological Group. European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Collaborative Group. 1998

J A Witjes, and A P v d Meijden, and L Collette, and R Sylvester, and F M Debruyne, and A van Aubel, and W P Witjes
Department of Urology, University Hospital, Nijmegen, The Netherlands.

OBJECTIVE To determine long-term efficacy of intravesical mitomycin C (MMC) versus bacille Calmette-Guérin (BCG) in patients with superficial bladder cancer with regard to recurrences and progression. METHODS Patients with superficial bladder cancer (pTa, pT1, pTis) were treated with intravesical MMC (30 mg, weekly for 4 weeks, and thereafter monthly for 5 months) or BCG (weekly for 6 weeks). RESULTS Three hundred forty-four patients were eligible (171 in the BCG group, 173 in the MMC group). The median follow-up was 7.2 years. Toxicity was not significantly different between the two treatment groups. Efficacy of the two treatment policies was similar with regard to tumor recurrence. With regard to progression to invasive disease, MMC was more effective than BCG in patients without carcinoma in situ (CIS) (P = 0.006). CONCLUSIONS We can confirm the conclusions of other studies that intravesical treatment with 30 mg of MMC remains an effective treatment option that can also be used in high-risk patients. Like others, we could not confirm that a 6-week course of BCG is more effective in the prevention of tumor progression. Of the 33 patients with tumor progression after intravesical therapy, 20 died of bladder cancer, confirming that tumor progression after intravesical therapy carries a poor prognosis. In this study the difference in toxicity between BCG and MMC was not significant. When comparing studies with MMC and BCG, differences in treatment schedule and/or patient selection should be kept in mind.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D001749 Urinary Bladder Neoplasms Tumors or cancer of the URINARY BLADDER. Bladder Cancer,Bladder Neoplasms,Cancer of Bladder,Bladder Tumors,Cancer of the Bladder,Malignant Tumor of Urinary Bladder,Neoplasms, Bladder,Urinary Bladder Cancer,Bladder Cancers,Bladder Neoplasm,Bladder Tumor,Cancer, Bladder,Cancer, Urinary Bladder,Neoplasm, Bladder,Neoplasm, Urinary Bladder,Tumor, Bladder,Tumors, Bladder,Urinary Bladder Neoplasm
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000276 Adjuvants, Immunologic Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. Immunoactivators,Immunoadjuvant,Immunoadjuvants,Immunologic Adjuvant,Immunopotentiator,Immunopotentiators,Immunostimulant,Immunostimulants,Adjuvant, Immunologic,Adjuvants, Immunological,Immunologic Adjuvants,Immunological Adjuvant,Adjuvant, Immunological,Immunological Adjuvants
D000283 Administration, Intravesical The instillation or other administration of drugs into the bladder, usually to treat local disease, including neoplasms. Bladder Drug Administration,Drug Administration, Bladder,Instillation, Bladder,Intravesical Drug Administration,Administration, Intravesical Drug,Injections, Intravesical,Intravesical Administration,Intravesical Injection,Intravesical Instillation,Administration, Bladder Drug,Administrations, Bladder Drug,Administrations, Intravesical,Administrations, Intravesical Drug,Bladder Drug Administrations,Bladder Instillation,Bladder Instillations,Drug Administration, Intravesical,Drug Administrations, Bladder,Drug Administrations, Intravesical,Injection, Intravesical,Instillation, Intravesical,Instillations, Bladder,Instillations, Intravesical,Intravesical Administrations,Intravesical Drug Administrations,Intravesical Injections,Intravesical Instillations
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000369 Aged, 80 and over Persons 80 years of age and older. Oldest Old

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