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Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy

2020; Lippincott Williams & Wilkins; Volume: 204; Issue: 3 Linguagem: Inglês

10.1097/ju.0000000000001029

1527-3792

Maria F. Becerra, Vivek Venkatramani, Isildinha M. Reis, Nachiketh Soodana‐Prakash, Sanoj Punnen, Mark L. Gonzalgo, Shyamal Raolji, Erik P. Castle, Michael Woods, Robert S. Svatek, Alon Z. Weizer, Badrinath R. Konety, Mathew Tollefson, Tracey L. Krupski, Norm D. Smith, Ahmad Shabsigh, Daniel A. Barocas, Marcus L. Quek, Atreya Dash, Dipen J. Parekh,

Bladder and Urothelial Cancer Treatments

No AccessJournal of UrologyAdult Urology1 Sep 2020Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical CystectomyThis article is commented on by the following:Editorial CommentEditorial Comment Maria F. Becerra, Vivek Venkatramani, Isildinha M. Reis, Nachiketh Soodana-Prakash, Sanoj Punnen, Mark L. Gonzalgo, Shyamal Raolji, Erik P. Castle, Michael E. Woods, Robert S. Svatek, Alon Z. Weizer, Badrinath R. Konety, Mathew Tollefson, Tracey L. Krupski, Norm D. Smith, Ahmad Shabsigh, Daniel A. Barocas, Marcus L. Quek, Atreya Dash, and Dipen J. Parekh Maria F. BecerraMaria F. Becerra Department of Urology, University of Miami Miller School of Medicine, Miami, Florida , Vivek VenkatramaniVivek Venkatramani Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida , Isildinha M. ReisIsildinha M. Reis Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida , Nachiketh Soodana-PrakashNachiketh Soodana-Prakash Department of Urology, University of Miami Miller School of Medicine, Miami, Florida , Sanoj PunnenSanoj Punnen Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida , Mark L. GonzalgoMark L. Gonzalgo Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida , Shyamal RaoljiShyamal Raolji Department of Urology, University of Miami Miller School of Medicine, Miami, Florida , Erik P. CastleErik P. Castle Department of Urology, Mayo Clinic, Phoenix, Arizona , Michael E. WoodsMichael E. Woods Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina , Robert S. SvatekRobert S. Svatek Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas , Alon Z. WeizerAlon Z. Weizer Department of Urology, University of Michigan, Ann Arbor, Michigan , Badrinath R. KonetyBadrinath R. Konety Department of Urology, University of Minnesota, Minneapolis, Minnesota , Mathew TollefsonMathew Tollefson Department of Urology, Mayo Clinic, Phoenix, Arizona , Tracey L. KrupskiTracey L. Krupski Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia , Norm D. SmithNorm D. Smith Department of Urology, University of Chicago, Chicago, Illinois , Ahmad ShabsighAhmad Shabsigh Department of Urology, Ohio State University, Columbus, Ohio , Daniel A. BarocasDaniel A. Barocas Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee , Marcus L. QuekMarcus L. Quek Department of Urology, Loyola University Medical Center, Maywood, Illinois , Atreya DashAtreya Dash Department of Urology, University of Washington, Seattle, Washington , and Dipen J. ParekhDipen J. Parekh *Correspondence: Department of Urology, University of Miami Miller School of Medicine,1120 NW 14th St Suite 1551M, Miami, Florida 33136 telephone: 305-243-6591; E-mail Address: [email protected] Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida View All Author Informationhttps://doi.org/10.1097/JU.0000000000001029AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer. Materials and Methods: Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life. Results: Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019). Conclusions: Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling. References 1. WHO: Constitution of the World Health Organization. Available at https://www.who.int/about/who-we-are/constitution. Google Scholar 2. : Health, health-related quality of life, and quality of life: what is the difference?Pharmacoeconomics 2016; 34: 645. Google Scholar 3. : Surgical decision making: challenging dogma and incorporating patient preferences. JAMA 2017; 317: 357. Google Scholar 4. : Treatment of non-metastatic muscle-invasive bladder cancer: AUA/ASCO/ASTRO/SUO guideline. J Urol 2017; 198: 552. Link, Google Scholar 5. : Complications and health-related quality of life after robot-assisted versus open radical cystectomy: a systematic review and meta-analysis of four RCTs. Syst Rev 2017; 6: 150. Google Scholar 6. : Long-term health-related quality of life outcomes following radical cystectomy. Urology 2017; 106: 82. Google Scholar 7. : Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet 2018; 391: 2525. Google Scholar 8. : Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol 1926; 170: 2003. 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Google Scholar 15. : Quality of life after radical cystectomy. Urol Clin North Am 2018; 45: 249. Google Scholar 16. : Health related quality of life (HRQoL) after cystectomy: comparison between orthotopic neobladder and ileal conduit diversion. Eur J Surg Oncol 2015; 41: 295. Google Scholar 17. : Psychometric characteristics of a condition-specific, health-related quality-of-life survey: the FACT-Vanderbilt Cystectomy Index. Urology 2012; 80: 77. Google Scholar 18. : Prospective comparison of quality-of-life outcomes between ileal conduit urinary diversion and orthotopic neobladder reconstruction after radical cystectomy: a statistical model. BJU Int 2014; 113: 726. Google Scholar 19. : Midterm health-related quality of life after radical cystectomy: a propensity score-matched analysis. Eur Urol Focus 2020; 6: 704. Google Scholar 20. : When should quality of life be measured after radical cystectomy?Eur Urol 2002; 42: 350. Google Scholar The RAZOR trial was supported by the National Institutes of Health National Cancer Institute (grant number RO1CA155388). No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor’s Note: This article is the first of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 626 and 627. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byClements M, Beech B, Atkinson T, Dalbagni G, Li Y, Vickers A, Herr H, Donat S, Sjoberg D, Tin A, Coleman J, Rapkin B, Laudone V and Bochner B (2023) Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized TrialJournal of Urology, Rodriguez-Homs M, Pessoa R, Konety B, Gershman B, Clark P, Bronsert M, Flaig T, Tevis S, Lloyd G, Morrison J and Kim S (2022) Reply by AuthorsUrology Practice, VOL. 9, NO. 6, (559-559), Online publication date: 1-Nov-2022.Smith J (2020) This Month in Adult UrologyJournal of Urology, VOL. 204, NO. 3, (403-405), Online publication date: 1-Sep-2020.Related articlesJournal of Urology25 Jun 2020Editorial CommentJournal of Urology25 Jun 2020Editorial Comment Volume 204Issue 3September 2020Page: 450-459Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordsurinary diversioncystectomyquality of lifeMetricsAuthor Information Maria F. Becerra Department of Urology, University of Miami Miller School of Medicine, Miami, Florida More articles by this author Vivek Venkatramani Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida More articles by this author Isildinha M. Reis Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Nachiketh Soodana-Prakash Department of Urology, University of Miami Miller School of Medicine, Miami, Florida More articles by this author Sanoj Punnen Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida More articles by this author Mark L. Gonzalgo Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida More articles by this author Shyamal Raolji Department of Urology, University of Miami Miller School of Medicine, Miami, Florida More articles by this author Erik P. Castle Department of Urology, Mayo Clinic, Phoenix, Arizona More articles by this author Michael E. Woods Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina More articles by this author Robert S. Svatek Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas More articles by this author Alon Z. Weizer Department of Urology, University of Michigan, Ann Arbor, Michigan More articles by this author Badrinath R. Konety Department of Urology, University of Minnesota, Minneapolis, Minnesota More articles by this author Mathew Tollefson Department of Urology, Mayo Clinic, Phoenix, Arizona More articles by this author Tracey L. Krupski Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia More articles by this author Norm D. Smith Department of Urology, University of Chicago, Chicago, Illinois More articles by this author Ahmad Shabsigh Department of Urology, Ohio State University, Columbus, Ohio More articles by this author Daniel A. Barocas Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee More articles by this author Marcus L. Quek Department of Urology, Loyola University Medical Center, Maywood, Illinois More articles by this author Atreya Dash Department of Urology, University of Washington, Seattle, Washington More articles by this author Dipen J. Parekh Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida *Correspondence: Department of Urology, University of Miami Miller School of Medicine,1120 NW 14th St Suite 1551M, Miami, Florida 33136 telephone: 305-243-6591; E-mail Address: [email protected] More articles by this author Expand All The RAZOR trial was supported by the National Institutes of Health National Cancer Institute (grant number RO1CA155388). No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor’s Note: This article is the first of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 626 and 627. Advertisement PDF downloadLoading ...