Francesco Soria1, David D'Andrea2, Mohammad Abufaraj3, Marco Moschini4, Andrea Giordano5, Kilian M Gust2, Pierre I Karakiewicz6, Marek Babjuk7, Paolo Gontero5, Shahrokh F Shariat8. 1. Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy; Department of Urology, Medical University of Vienna, Vienna, Austria. 2. Department of Urology, Medical University of Vienna, Vienna, Austria. 3. Department of Urology, Medical University of Vienna, Vienna, Austria; Department of Special Surgery, Jordan University Hospital, The University of Jordan, Amman, Jordan. 4. Department of Urology, Medical University of Vienna, Vienna, Austria; Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland; Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy. 5. Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy. 6. Division of Urology, University of Montreal Hospital Center, Montreal, Québec, Canada. 7. Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic. 8. Department of Urology, Medical University of Vienna, Vienna, Austria; Department of Special Surgery, Jordan University Hospital, The University of Jordan, Amman, Jordan; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University, Moscow, Russia; Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA. Electronic address: shahrokh.shariat@meduniwien.ac.at.
Abstract
BACKGROUND: There is an urgent need to provide a risk-stratification tool for intermediate-risk non-muscle-invasive bladder cancer (NMIBC), especially at the time of bacillus Calmette-Guerin (BCG) shortage. OBJECTIVE: To assess whether patients with intermediate-risk NMIBC can be stratified into different risk groups, thereby providing a practical tool for the selection of the optimal adjuvant therapy, based on the individualized risk of disease progression. DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective analysis of 636 patients with intermediate-risk NMIBC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A multivariable Cox-regression model was built to evaluate the impact of each variable on recurrence and progression to muscle-invasive disease. A Cox-based nomogram to predict patient-specific probability of disease progression was performed, and the decision curve analysis (DCA) was used to evaluate its clinical benefit. RESULTS AND LIMITATIONS: Within a median follow-up of 92 mo (interquartile range 56-118), disease recurrence and progression occurred in 346 (54%) and 91 (14%) patients, respectively. On multivariable analysis, age, early recurrence (<12 mo), and tumor size≥3cm were found to be independent predictors of progression. The Harrell C-index of the model for the prediction of progression was 0.75 and exceeded that of the model proposed by the International Bladder Consultation Group. DCA showed superior net benefits for the nomogram compared with the strategies of treating all/none and previous predictive models. Limitations are inherent to the retrospective design. CONCLUSIONS: We provided a risk-stratification tool that helps identify individual risk of disease progression in patients with intermediate-risk NMIBC. This tool outperforms standard strategies in the threshold probability range of interest and could help select the optimal intravesical therapy regimen based on the individual risk of disease progression. PATIENT SUMMARY: In this study, we provided a practical tool for risk stratification in patients with intermediate-risk non-muscle-invasive bladder cancer. This tool may help select the most appropriate adjuvant therapy (either bacillus Calmette-Guerin [BCG] or chemotherapy) based on patient and tumor characteristics, thus making a step forward toward the era of personalized medicine.
BACKGROUND: There is an urgent need to provide a risk-stratification tool for intermediate-risk non-muscle-invasive bladder cancer (NMIBC), especially at the time of bacillus Calmette-Guerin (BCG) shortage. OBJECTIVE: To assess whether patients with intermediate-risk NMIBC can be stratified into different risk groups, thereby providing a practical tool for the selection of the optimal adjuvant therapy, based on the individualized risk of disease progression. DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective analysis of 636 patients with intermediate-risk NMIBC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A multivariable Cox-regression model was built to evaluate the impact of each variable on recurrence and progression to muscle-invasive disease. A Cox-based nomogram to predict patient-specific probability of disease progression was performed, and the decision curve analysis (DCA) was used to evaluate its clinical benefit. RESULTS AND LIMITATIONS: Within a median follow-up of 92 mo (interquartile range 56-118), disease recurrence and progression occurred in 346 (54%) and 91 (14%) patients, respectively. On multivariable analysis, age, early recurrence (<12 mo), and tumor size≥3cm were found to be independent predictors of progression. The Harrell C-index of the model for the prediction of progression was 0.75 and exceeded that of the model proposed by the International Bladder Consultation Group. DCA showed superior net benefits for the nomogram compared with the strategies of treating all/none and previous predictive models. Limitations are inherent to the retrospective design. CONCLUSIONS: We provided a risk-stratification tool that helps identify individual risk of disease progression in patients with intermediate-risk NMIBC. This tool outperforms standard strategies in the threshold probability range of interest and could help select the optimal intravesical therapy regimen based on the individual risk of disease progression. PATIENT SUMMARY: In this study, we provided a practical tool for risk stratification in patients with intermediate-risk non-muscle-invasive bladder cancer. This tool may help select the most appropriate adjuvant therapy (either bacillus Calmette-Guerin [BCG] or chemotherapy) based on patient and tumor characteristics, thus making a step forward toward the era of personalized medicine.
Authors: Chiara Lonati; Luca Afferi; Andrea Mari; Andrea Minervini; Wojciech Krajewski; Marco Borghesi; Gerald B Schulz; Michael Rink; Francesco Montorsi; Alberto Briganti; Renzo Colombo; Alberto Martini; Andrea Necchi; Roberto Contieri; Rodolfo Hurle; Paolo Umari; Stefania Zamboni; Claudio Simeone; Francesco Soria; Giancarlo Marra; Paolo Gontero; Jeremy Yuen-Chun Teoh; Tobias Klatte; Anne-Sophie Bajeot; Mathieu Roumiguié; Morgan Rouprêt; Alexandra Masson-Lecomte; Ekaterina Laukhtina; Anne Sophie Valiquette; M Carmen Mir; Alessandro Antonelli; Sarah M H Einerhand; Kees Hendricksen; Roberto Carando; Christian D Fankhauser; Philipp Baumeister; Agostino Mattei; Shahrokh F Shariat; Marco Moschini Journal: World J Urol Date: 2022-02-26 Impact factor: 4.226
Authors: Mihaela Georgiana Musat; Christina Soeun Kwon; Elizabeth Masters; Slaven Sikirica; Debduth B Pijush; Anna Forsythe Journal: Clinicoecon Outcomes Res Date: 2022-01-10
Authors: Satoshi Katayama; Keiichiro Mori; Benjamin Pradere; Ekaterina Laukhtina; Victor M Schuettfort; Fahad Quhal; Reza Sari Motlagh; Hadi Mostafaei; Nico C Grossmann; Pawel Rajwa; Marco Moschini; Romain Mathieu; Mohammad Abufaraj; David D'Andrea; Eva Compérat; Martin Haydter; Shin Egawa; Yasutomo Nasu; Shahrokh F Shariat Journal: World J Urol Date: 2021-06-18 Impact factor: 4.226