Felix V Chen1, Tulay Koru-Sengul2, Feng Miao3, Joshua S Jue1, Mahmoud Alameddine1, Devina J Dave4, Sanoj Punnen5, Dipen J Parekh5, Chad R Ritch5, Mark L Gonzalgo6. 1. Department of Urology, University of Miami Miller School of Medicine, Miami, FL. 2. Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL. 3. Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL. 4. Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL. 5. Department of Urology, University of Miami Miller School of Medicine, Miami, FL; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL. 6. Department of Urology, University of Miami Miller School of Medicine, Miami, FL; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL. Electronic address: m.gonzalgo@miami.edu.
Abstract
BACKGROUND: Contemporary randomized controlled trials exploring adjuvant chemotherapy (AC) for bladder cancer (BCa) have yielded inconsistent results due to premature termination and/or poor patient accrual. OBJECTIVE: To compare efficacy of AC vs. observation after radical cystectomy stratified by disease stage in a propensity-matched cohort. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective study that included patients who underwent radical cystectomy for any pT, N0-1, M0 BCa from the National Cancer Data Base (2004-2014). Patients who underwent AC were 1:1 propensity matched with patients who received observation only. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall survival was assessed with multivariable Cox regression models where adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) were calculated. RESULTS AND LIMITATIONS: After coarsened exact 1:1 propensity matching, 3,066 patients (AC 1,533; observation 1,533) were included in the analysis. There were no significant differences in patient-, facility-, or tumor-level characteristics among cohorts. Compared with patients who underwent observation, recipients of AC had improved overall survival (aHR 0.67; 95% CI 0.61-0.74). Patients with pT2-4, pN1 disease significantly benefited from AC. Among the pN0 cohort, improved survival from AC was observed only in stages pT3 (aHR 0.67; 95% CI 0.55-0.83) and pT4 (aHR 0.70; 95% CI 0.50-0.98). CONCLUSIONS: AC was associated with improved survival in locally advanced (pT3-4, pN0) and regionally advanced (pT2-4, pN1) chemotherapy-naive BCa.
BACKGROUND: Contemporary randomized controlled trials exploring adjuvant chemotherapy (AC) for bladder cancer (BCa) have yielded inconsistent results due to premature termination and/or poor patient accrual. OBJECTIVE: To compare efficacy of AC vs. observation after radical cystectomy stratified by disease stage in a propensity-matched cohort. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective study that included patients who underwent radical cystectomy for any pT, N0-1, M0 BCa from the National Cancer Data Base (2004-2014). Patients who underwent AC were 1:1 propensity matched with patients who received observation only. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall survival was assessed with multivariable Cox regression models where adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) were calculated. RESULTS AND LIMITATIONS: After coarsened exact 1:1 propensity matching, 3,066 patients (AC 1,533; observation 1,533) were included in the analysis. There were no significant differences in patient-, facility-, or tumor-level characteristics among cohorts. Compared with patients who underwent observation, recipients of AC had improved overall survival (aHR 0.67; 95% CI 0.61-0.74). Patients with pT2-4, pN1 disease significantly benefited from AC. Among the pN0 cohort, improved survival from AC was observed only in stages pT3 (aHR 0.67; 95% CI 0.55-0.83) and pT4 (aHR 0.70; 95% CI 0.50-0.98). CONCLUSIONS: AC was associated with improved survival in locally advanced (pT3-4, pN0) and regionally advanced (pT2-4, pN1) chemotherapy-naive BCa.
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