Andrea Necchi1, Gregory R Pond2, Marco Moschini3, Elizabeth R Plimack4, Gunter Niegisch5, Evan Y Yu6, Aristotelis Bamias7, Neeraj Agarwal8, Ulka Vaishampayan9, Christine Theodore10, Srikala S Sridhar11, Jonathan E Rosenberg12, Joaquim Bellmunt13, Andrea Gallina3, Renzo Colombo3, Francesco Montorsi3, Alberto Briganti3, Matthew D Galsky14. 1. Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: andrea.necchi@istitutotumori.mi.it. 2. McMaster University, Hamilton, Ontario, Canada. 3. Vita Salute San Raffaele University and Department of Urology, IRCCS San Raffaele Hospital, Milano, Italy. 4. Fox Chase Cancer Center, Philadelphia, PA. 5. Heinrich-Heine-University, Medical faculty, Department of Urology, Düsseldorf, Germany. 6. University of Washington, Seattle, WA. 7. University of Athens, Athens, Greece. 8. University of Utah, Salt Lake City, UT. 9. Wayne State University/Karmanos Cancer Center, Detroit, MI. 10. Center Georges-François Leclerc, Dijon, France. 11. Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada. 12. Memorial Sloan-Kettering Cancer Center, New York, NY. 13. Dana-Farber Cancer Institute, Boston, MA. 14. Mount Sinai School of Medicine, Tisch Cancer Institute, New York, NY.
Abstract
BACKGROUND: Limited information is available about the pattern of relapse after perioperative chemotherapy with radical cystectomy (RC) vs. RC alone in muscle-invasive bladder cancer. PATIENTS AND METHODS: Data from 1082 patients of the Retrospective International Study of Invasive/Advanced Cancer of the Urothelium database, treated from February 1990 to December 2013 at 27 centers in the United States, Europe, Israel, and Canada, were collected. Locoregional relapse was defined as any pelvic lymph node or soft tissue-only recurrences. Cumulative incidence methods were used to estimate time to locoregional relapse (TTRL). Cox regression analyses were performed and a nomogram for 12-month locoregional relapse-free survival (RFS) was developed. The nomogram was applied to an external data set (n = 1021). RESULTS: A total of 517 patients (47.8%) developed a relapse: 177 (16.4%) exclusive locoregional relapse. In multivariable analyses, perioperative chemotherapy was associated with longer TTRL (P < .001). Other factors were nonurothelial histology (P = .013), pT-stage (P < .001), and surgical margins (P < .001). The concordance index of the model was 0.681 (95% bootstrapped confidence interval, 0.666-0.716). Risk group categories were obtained according to nomogram tertiles. Despite, overall, observed locoregional RFS in the validation cohort exceeding predicted results, for high-risk patients (80 points or less, lowest nomogram tertile) observed 12-month RFS was similar between development and validation cohorts (60.1% and 66.6%). The study is limited by its retrospective nature. CONCLUSION: In the largest study, to our knowledge, that analyzed locoregional recurrences after RC, we propose a risk prediction tool for exclusive locoregional failures that might be suitable for clinical studies. Patients best suited for adjuvant radiotherapy might be those within the lowest nomogram tertile. Prospective trials are needed to validate findings.
BACKGROUND: Limited information is available about the pattern of relapse after perioperative chemotherapy with radical cystectomy (RC) vs. RC alone in muscle-invasive bladder cancer. PATIENTS AND METHODS: Data from 1082 patients of the Retrospective International Study of Invasive/Advanced Cancer of the Urothelium database, treated from February 1990 to December 2013 at 27 centers in the United States, Europe, Israel, and Canada, were collected. Locoregional relapse was defined as any pelvic lymph node or soft tissue-only recurrences. Cumulative incidence methods were used to estimate time to locoregional relapse (TTRL). Cox regression analyses were performed and a nomogram for 12-month locoregional relapse-free survival (RFS) was developed. The nomogram was applied to an external data set (n = 1021). RESULTS: A total of 517 patients (47.8%) developed a relapse: 177 (16.4%) exclusive locoregional relapse. In multivariable analyses, perioperative chemotherapy was associated with longer TTRL (P < .001). Other factors were nonurothelial histology (P = .013), pT-stage (P < .001), and surgical margins (P < .001). The concordance index of the model was 0.681 (95% bootstrapped confidence interval, 0.666-0.716). Risk group categories were obtained according to nomogram tertiles. Despite, overall, observed locoregional RFS in the validation cohort exceeding predicted results, for high-risk patients (80 points or less, lowest nomogram tertile) observed 12-month RFS was similar between development and validation cohorts (60.1% and 66.6%). The study is limited by its retrospective nature. CONCLUSION: In the largest study, to our knowledge, that analyzed locoregional recurrences after RC, we propose a risk prediction tool for exclusive locoregional failures that might be suitable for clinical studies. Patients best suited for adjuvant radiotherapy might be those within the lowest nomogram tertile. Prospective trials are needed to validate findings.
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