• Malte W Vetterlein, Thomas Seisen, Matthias May, Philipp Nuhn, Michael Gierth, Roman Mayr, Hans-Martin Fritsche, Maximilian Burger, Vladimir Novotny, Michael Froehner, Manfred P Wirth, Chris Protzel, Oliver W Hakenberg, Florian Roghmann, Rein-Jüri Palisaar, Joachim Noldus, Armin Pycha, Patrick J Bastian, Quoc-Dien Trinh, Evanguelos Xylinas, Shahrokh F Shariat, Michael Rink, Felix K-H Chun, Roland Dahlem, Margit Fisch, Atiqullah Aziz, and PROMETRICS 2011 Study Group.
• Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
• Eur Urol Focus. 2018 Mar 1; 4 (2): 252-259.

BackgroundThe benefit of adjuvant chemotherapy (AC) for muscle-invasive urothelial carcinoma of the bladder (UCB) after radical cystectomy (RC) is controversial.ObjectiveTo assess the effectiveness of AC after RC for muscle-invasive UCB in contemporary European routine practice.Design, Setting, And ParticipantsBy using a prospectively collected European multicenter database, we compared survival outcomes between patients who received AC versus observation after RC for locally advanced (pT3/T4) and/or pelvic lymph node-positive (pN+) muscle-invasive UCB in 2011.InterventionAC versus observation after RC.Outcome Measurements And Statistical AnalysisInverse probability of treatment weighting (IPTW)-adjusted Cox regression and competing risks analyses were performed to compare overall survival (OS) as well as cancer-specific and other-cause mortality between patients who received AC versus observation.Results And LimitationsOverall, 224 patients who received AC (n = 84) versus observation (n = 140) were included. The rate of 3-yr OS in patients who received AC versus observation was 62.1% versus 40.9%, respectively (p = 0.014). In IPTW-adjusted Cox regression analysis, AC versus observation was associated with an OS benefit (hazard ratio: 0.47; 95% confidence interval [CI]: 0.25-0.86; p = 0.014). In IPTW-adjusted competing risks analysis, AC versus observation was associated with a decreased risk of cancer-specific mortality (subhazard ratio: 0.51; 95% CI: 0.26-0.98; p = 0.044) without any increased risk of other-cause mortality (subhazard ratio: 0.48; 95% CI: 0.14-1.60; p = 0.233). Limitations include the relatively small sample size as well as the potential presence of unmeasured confounders related to the observational study design.ConclusionsWe found that AC versus observation was associated with a survival benefit after RC in patients with pT3/T4 and/or pN+ UCB. These results should encourage physicians to deliver AC and researchers to pursue prospective or large observational investigations.Patient SummaryOverall survival and cancer-specific survival benefit was found in patients who received adjuvant chemotherapy relative to observation after radical cystectomy for locally advanced and/or pelvic lymph node-positive bladder cancer.Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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