Anti-androgen monotherapy versus gonadotropin-releasing hormone agonists in men with advanced, non-metastatic prostate cancer: a register-based, observational study

References

• Cornford P, Bellmunt J, Bolla M, et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer. Eur Urol. 2017;71:630–642.
   PubMed Web of Science ®Google Scholar
• Guy D, Ghanem G, Loblaw A, et al. Diagnosis, referral, and primary treatment decisions in newly diagnosed prostate cancer patients in a multidisciplinary diagnostic assessment program. Can Urol Assoc J. 2016;10:120–125.
   PubMed Web of Science ®Google Scholar
• Thomsen FB, Mikkelsen MK, Hansen RB, et al. Clinical characteristics and primary management of patients diagnosed with prostate cancer between 2007 and 2013: status from a Danish primary referral center. Acta Oncol. 2016;55:1456–1460.
   PubMed Web of Science ®Google Scholar
• Lycken M, Garmo H, Adolfsson J, et al. Patterns of androgen deprivation therapies among men diagnosed with localised prostate cancer: a population-based study. Eur J Cancer. 2014;50:1789–1798.
   PubMed Web of Science ®Google Scholar
• Mottet N, Bellmunt J, Bolla M, et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017;71:618–629.
   PubMed Web of Science ®Google Scholar
• Albertsen PC, Klotz L, Tombal B, et al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol. 2014;65:565–573.
   PubMed Web of Science ®Google Scholar
• Reid P, Kantoff P, Oh W. Antiandrogens in prostate cancer. Invest New Drugs. 1999;17:271–284.
   PubMed Web of Science ®Google Scholar
• Crawford ED, Shore ND, Moul JW, et al. Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix. Urology. 2014;83:1122–1128.
   PubMed Web of Science ®Google Scholar
• Iversen P, McLeod DG, See WA, et al. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010;105:1074–1081.
   PubMed Web of Science ®Google Scholar
• Nguyen PL, Alibhai SM, Basaria S, et al. Adverse effects of androgen deprivation therapy and strategies to mitigate them. Eur Urol. 2015;67:825–836.
   PubMed Web of Science ®Google Scholar
• Thorstenson A, Bratt O, Akre O, et al. Incidence of fractures causing hospitalisation in prostate cancer patients: results from the population-based PCBaSe Sweden. Eur J Cancer. 2012;48:1672–1681.
   PubMed Web of Science ®Google Scholar
• Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. Jco. 2006;24:4448–4456.
   PubMed Web of Science ®Google Scholar
• Van Hemelrijck M, Garmo H, Holmberg L, et al. Absolute and relative risk of cardiovascular disease in men with prostate cancer: results from the Population-Based PCBaSe Sweden. J Clin Oncol. 2010;28:3448–3456.
   PubMed Web of Science ®Google Scholar
• Nead KT, Gaskin G, Chester C, et al. Association between androgen deprivation therapy and risk of dementia. JAMA Oncol. 2017;3:49–55.
   PubMed Web of Science ®Google Scholar
• Dockery F, Bulpitt CJ, Agarwal S, et al. Testosterone suppression in men with prostate cancer leads to an increase in arterial stiffness and hyperinsulinaemia. Clin Sci. 2003;104:195–201.
   PubMed Web of Science ®Google Scholar
• Malkin CJ, Pugh PJ, Jones RD, et al. Testosterone as a protective factor against atherosclerosis–immunomodulation and influence upon plaque development and stability. J Endocrinol. 2003;178:373–380.
   PubMed Web of Science ®Google Scholar
• Kunath F, Grobe HR, Rucker G, et al. Non-steroidal antiandrogen monotherapy compared with luteinising hormone-releasing hormone agonists or surgical castration monotherapy for advanced prostate cancer. Cochrane Database Syst Rev. 2014 Jun 30;(6): CD009266.
   Web of Science ®Google Scholar
• Boccardo F, Rubagotti A, Barichello M, et al. Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer patients: results of an Italian Prostate Cancer Project study. J Clin Oncol. 1999;17:2027–2038.
   PubMed Web of Science ®Google Scholar
• Iversen P, Tyrrell CJ, Kaisary AV, et al. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000;164:1579–1582.
   PubMed Web of Science ®Google Scholar
• EM Agency. Bicalutamide 150 mg; 2007 [updated 2007 May 24; cited 2018 Feb 01]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Bicalutamide_150_mg/human_referral_000116.jsp
   Google Scholar
• Faria R, Alava MH, Manca A, Wailoo AJ. National Institute for Health and Care: the use of observational data to inform estimates of treatment effectiveness in technology appraisal: methods for comparative individual patient data; 2015. Available from: http://nicedsu.org.uk/technical-support-documents/observational-data-tsd/
   Google Scholar
• Egger M, Moons KG, Fletcher C. GetReal: from efficacy in clinical trials to relative effectiveness in the real world. Res Synth Methods. 2016;7:278–281.
   PubMed Web of Science ®Google Scholar
• Unger JM, Barlow WE, Martin DP, et al. Comparison of survival outcomes among cancer patients treated in and out of clinical trials. J Natl Cancer Inst. 2014;106:dju002.
   PubMedGoogle Scholar
• Van Hemelrijck M, Garmo H, Wigertz A, et al. Cohort Profile Update: The National Prostate Cancer Register of Sweden and Prostate Cancer data Base – a refined prostate cancer trajectory. Int J Epidemiol. 2016;45:73–82.
   PubMed Web of Science ®Google Scholar
• Sterne JAC, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
   Google Scholar
• Grundmark B, Garmo H, Zethelius B, et al. Anti-androgen prescribing patterns, patient treatment adherence and influencing factors; results from the nationwide PCBaSe Sweden. Eur J Clin Pharmacol. 2012;68:1619–1630.
   PubMed Web of Science ®Google Scholar
• Van Buuren S. Flexible imputation of missing data. New York: CRC press; 2012.
   Google Scholar
• Glynn RJ, Schneeweiss S, Sturmer T. Indications for propensity scores and review of their use in pharmacoepidemiology. Basic Clin Pharmacol Toxicol. 2006;98:253–259.
   PubMed Web of Science ®Google Scholar
• Gu XS, Rosenbaum PR. Comparison of multivariate matching methods: structures, distances, and algorithms. J Comput Graph Stat. 1993;2:405–420.
   Google Scholar
• Vickers AJ, Sjoberg DD, European U. Guidelines for reporting of statistics in European Urology. Eur Urol. 2015;67:181–187.
   PubMed Web of Science ®Google Scholar
• Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016;7:144–146.
   PubMedGoogle Scholar
• Tomic K, Berglund A, Robinson D, et al. Capture rate and representativity of The National Prostate Cancer Register of Sweden. Acta Oncol. 2015;54:158–163.
   PubMed Web of Science ®Google Scholar
• Tomic K, Sandin F, Wigertz A, et al. Evaluation of data quality in the National Prostate Cancer Register of Sweden. Eur J Cancer. 2015;51:101–111.
   PubMed Web of Science ®Google Scholar