Jorg R Oddens1, Richard J Sylvester2, Maurizio A Brausi3, Wim J Kirkels4, Cees van de Beek5, George van Andel6, Theo M de Reijke7, Stephen Prescott8, J Alfred Witjes9, Willem Oosterlinck10. 1. Department of Urology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. Electronic address: J.oddens@jbz.nl. 2. Headquarters, European Organization for Research and Treatment of Cancer, Brussels, Belgium. 3. Department of Urology, New Estense-S. Agostino Hospital Ausl, Modena, Italy. 4. Department of Urology, Erasmus Medical Centre, Rotterdam, The Netherlands. 5. Department of Urology, Academic Hospital, Maastricht, The Netherlands. 6. Department of Urology, OLVG, Amsterdam, The Netherlands. 7. Department of Urology, Academic Medical Centre, Amsterdam, The Netherlands. 8. Department of Urology, St James's University Hospital, Leeds, UK. 9. Department of Urology, Radboud University Nijmegen Medical Center, The Netherlands. 10. Department of Urology, Gent University Hospital, Ghent, Belgium.
Abstract
BACKGROUND: Although maintenance bacillus Calmette-Guérin (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- orhigh-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 (p<0.001), and NMIBC-specific survival (p=0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with epirubicin in patients >70 yr. CONCLUSIONS: In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated withBCG, 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-Guérin 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=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
RCT Entities:
BACKGROUND: Although maintenance bacillus Calmette-Guérin (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 (p<0.001), and NMIBC-specific survival (p=0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with epirubicin in patients >70 yr. CONCLUSIONS: In intermediate- and high-risk Ta T1 urothelial bladder cancerpatients 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-Guérin 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=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
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Authors: Karim Chamie; Nicholas M Donin; Pia Klöpfer; Paul Bevan; Barbara Fall; Olaf Wilhelm; Stephan Störkel; Jonathan Said; Michael Gambla; Robert E Hawkins; Gustavo Jankilevich; Anil Kapoor; Evgeny Kopyltsov; Michael Staehler; Kimmo Taari; Alberto J A Wainstein; Allan J Pantuck; Arie S Belldegrun Journal: JAMA Oncol Date: 2017-07-01 Impact factor: 31.777
Authors: B Calò; F Sanguedolce; F Fortunato; G Stallone; N d'Altilia; M Chirico; U Falagario; Vito Mancini; G Carrieri; L Cormio Journal: Medicine (Baltimore) Date: 2019-08 Impact factor: 1.817