The Effect of Age on the Efficacy of Maintenance Bacillus Calmette-Guerin Relative to Maintenance Epirubicin in Patients with Stage Ta T1 Urothelial Bladder Cancer: Results from EORTC Genito-Urinary Group Study 30911

Autor: Richard J. Sylvester, Jorg R. Oddens, George van Andel, J. Alfred Witjes, Cees van de Beek, Wim J. Kirkels, Theo M. de Reijke, Maurizio A. Brausi, Stephen Prescott, Willem Oosterlinck
Přispěvatelé: Urologie, RS: MHeNs - R3 - Neuroscience, Urology, Erasmus MC other, CCA -Cancer Center Amsterdam
Rok vydání: 2014
Předmět:
Male
medicine.medical_specialty
Multivariate analysis
Urology
Urinary system
Non-muscle-invasive bladder cancer
Cystectomy
Risk Assessment
Disease-Free Survival
Drug Administration Schedule
Age
SDG 3 - Good Health and Well-being
Internal medicine
Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15]
Medicine
Humans
Neoplasm Invasiveness
Stage (cooking)
Bacillus Calmette-Guerin
Aged
Neoplasm Staging
Proportional Hazards Models
Epirubicin
Aged
80 and over
Carcinoma
Transitional Cell
Bladder cancer
Dose-Response Relationship
Drug
business.industry
Carcinoma in situ
Age Factors
Cancer
Middle Aged
medicine.disease
Prognosis
Surgery
Clinical trial
Survival Rate
Instillation therapy
Treatment Outcome
Urinary Bladder Neoplasms
Chemotherapy
Adjuvant
BCG Vaccine
Female
Neoplasm Recurrence
Local
business
medicine.drug
Zdroj: European Urology, 66, 4, pp. 694-701
European Urology, 66(4), 694-701. Elsevier
European Urology, 66, 694-701
European urology, 66(4), 694-701. Elsevier
ISSN: 1421-993X
0302-2838
Popis: Item does not contain fulltext BACKGROUND: Although maintenance bacillus Calmette-Guerin (BCG) is the recommended treatment in high-risk non-muscle-invasive bladder cancer (NMIBC), its efficacy in older patients is controversial. OBJECTIVE: To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG. DESIGN, SETTING, AND PARTICIPANTS: A total of 957 patients with intermediate- or high-risk Ta T1 (without carcinoma in situ) NMIBC were randomized in European Organization for Research and Treatment of Cancer (EORTC) trial 30911 comparing six weekly instillations of epirubicin, BCG, and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence, progression, overall survival, and NMIBC-specific survival with adjustment for EORTC risk scores. RESULTS AND LIMITATIONS: Overall, 822 eligible patients were included: 546 patients in the BCG with or without INH arms and 276 in the epirubicin arm. In patients treated with BCG with or without INH, 34.1% were >70 yr of age and 3.7% were >80 yr. With a median follow-up of 9.2 yr, patients >70 yr had a shorter time to progression (p=0.028), overall survival (p70 yr. CONCLUSIONS: In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated with BCG, patients >70 yr of age have a worse long-term prognosis; however, BCG is more effective than epirubicin independent of patient age. PATIENT SUMMARY: Intravesical bacillus Calmette-Guerin for non-muscle-invasive bladder cancer is less effective in patients >70 yr of age, but it is still more effective than epirubicin. TRIAL REGISTRATION: This study was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC 30911; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfes sional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
Databáze: OpenAIRE
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