Andrea Necchi1, Guru Sonpavde2, Salvatore Lo Vullo3, Daniele Giardiello3, Aristotelis Bamias4, Simon J Crabb5, Lauren C Harshman6, Joaquim Bellmunt6, Ugo De Giorgi7, Cora N Sternberg8, Linda Cerbone8, Sylvain Ladoire9, Yu-Ning Wong10, Evan Y Yu11, Simon Chowdhury12, Gunter Niegisch13, Sandy Srinivas14, Ulka N Vaishampayan15, Sumanta K Pal16, Neeraj Agarwal17, Ajjai Alva18, Jack Baniel19, Ali-Reza Golshayan20, Rafael Morales-Barrera21, Daniel W Bowles22, Matthew I Milowsky23, Christine Theodore24, Dominik R Berthold25, Gedske Daugaard26, Srikala S Sridhar27, Thomas Powles28, Jonathan E Rosenberg29, Matthew D Galsky30, Luigi Mariani3. 1. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address: andrea.necchi@istitutotumori.mi.it. 2. UAB Comprehensive Cancer Center, Birmingham, AL, USA. 3. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. 4. University of Athens, Athens, Greece. 5. University of Southampton, Southampton, UK. 6. Dana-Farber Cancer Institute, Boston, MA, USA. 7. IRCCS Istituto Scientifico Romagnolo per lo studio e la Cura dei Tumori, Meldola, Italy. 8. San Camillo Forlanini Hospital, Rome, Italy. 9. Center Georges-François Leclerc, Dijon, France. 10. Fox Chase Cancer Center, Philadelphia, PA, USA. 11. University of Washington, Seattle, WA, USA. 12. Guy's and St. Thomas' Hospital, London, UK. 13. Heinrich-Heine-University, Medical Faculty, Department of Urology, Düsseldorf, Germany. 14. Stanford University School of Medicine, Stanford, CA, USA. 15. Karmanos Cancer Institute, Detroit, MI, USA. 16. City of Hope Comprehensive Cancer Center, Duarte, CA, USA. 17. University of Utah, Salt Lake City, UT, USA. 18. University of Michigan, Ann Arbor, MI, USA. 19. Rabin Medical Center, Petach Tikva, Israel. 20. Medical University of South Carolina, Charleston, SC, USA. 21. Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain. 22. Denver Veterans Affairs Medical Center, Eastern Colorado Health Care System, Denver, CO, USA. 23. University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, NC, USA. 24. Hopital Foch, Suresnes, France. 25. Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. 26. Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 27. Princess Margaret Hospital, University Health Network, Toronto, Canada. 28. Barts Health and the Royal Free NHS Trust, Queen Mary University of London, London, UK. 29. Memorial Sloan-Kettering Cancer Center, New York, NY, USA. 30. Mount Sinai School of Medicine, Tisch Cancer Institute, New York, NY, USA.
Abstract
BACKGROUND: The available prognostic models for overall survival (OS) in patients with metastatic urothelial carcinoma (UC) have been derived from clinical trial populations of cisplatin-treated patients. OBJECTIVE: To develop a new model based on real-world patients. DESIGN, SETTING, AND PARTICIPANTS: Individual patient-level data from 29 centers were collected, including metastatic UC and first-line cisplatin- or carboplatin-based chemotherapy administered between January 2006 and January 2011. INTERVENTION: First-line, platinum-based, combination chemotherapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The population was randomly split into a development and a validation cohort. Generalized boosted regression modelling was used to screen out irrelevant variables and address multivariable analyses. Two nomograms were built to estimate OS probability, the first based on baseline factors and platinum agent, the second incorporating objective response (OR). The performance of the above nomograms and that of other available models was assessed. We plotted decision curves to evaluate the clinical usefulness of the two nomograms. RESULTS AND LIMITATIONS: A total of 1020 patients were analyzed (development: 687, validation: 333). In a platinum-stratified Cox model, significant variables for OS were performance status (p<0.001), white blood cell count (p=0.013), body mass index (p=0.003), ethnicity (p=0.012), lung, liver, or bone metastases (p<0.001), and prior perioperative chemotherapy (p=0.012). The c-index was 0.660. The distribution of the nomogram scores was associated with OR (p<0.001), and incorporating OR into the model further improved the c-index in the validation cohort (0.670). CONCLUSIONS: We developed and validated two nomograms for OS to be used before and after completion of first-line chemotherapy for metastatic UC. PATIENT SUMMARY: We proposed two models for estimating overall survival of patients with metastatic urothelial carcinoma receiving first-line, platinum-based chemotherapy. These nomograms have been developed on real-world patients who were treated outside of clinical trials and may be used irrespective of the chemotherapeutic platinum agent used.
BACKGROUND: The available prognostic models for overall survival (OS) in patients with metastatic urothelial carcinoma (UC) have been derived from clinical trial populations of cisplatin-treated patients. OBJECTIVE: To develop a new model based on real-world patients. DESIGN, SETTING, AND PARTICIPANTS: Individual patient-level data from 29 centers were collected, including metastatic UC and first-line cisplatin- or carboplatin-based chemotherapy administered between January 2006 and January 2011. INTERVENTION: First-line, platinum-based, combination chemotherapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The population was randomly split into a development and a validation cohort. Generalized boosted regression modelling was used to screen out irrelevant variables and address multivariable analyses. Two nomograms were built to estimate OS probability, the first based on baseline factors and platinum agent, the second incorporating objective response (OR). The performance of the above nomograms and that of other available models was assessed. We plotted decision curves to evaluate the clinical usefulness of the two nomograms. RESULTS AND LIMITATIONS: A total of 1020 patients were analyzed (development: 687, validation: 333). In a platinum-stratified Cox model, significant variables for OS were performance status (p<0.001), white blood cell count (p=0.013), body mass index (p=0.003), ethnicity (p=0.012), lung, liver, or bone metastases (p<0.001), and prior perioperative chemotherapy (p=0.012). The c-index was 0.660. The distribution of the nomogram scores was associated with OR (p<0.001), and incorporating OR into the model further improved the c-index in the validation cohort (0.670). CONCLUSIONS: We developed and validated two nomograms for OS to be used before and after completion of first-line chemotherapy for metastatic UC. PATIENT SUMMARY: We proposed two models for estimating overall survival of patients with metastatic urothelial carcinoma receiving first-line, platinum-based chemotherapy. These nomograms have been developed on real-world patients who were treated outside of clinical trials and may be used irrespective of the chemotherapeutic platinum agent used.
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