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Apalutamide treatment effect by patient age requires assessment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Post-hoc analysis assessed patients receiving 240\u2009mg\/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups. Prostate-specific antigen declines, radiographic progression-free survival, metastasis-free survival, overall survival (OS), HRQoL and safety were assessed using descriptive statistics, Kaplan-Meier method, Cox proportional-hazards model and mixed-effects model for repeated measures.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Hazard ratios (95% confidence intervals) generally favoured apalutamide plus ADT versus ADT alone across all endpoints regardless of age; e.g., OS values were 0.57 (0.40\u20130.80), 0.70 (0.54\u20130.91) and 0.74 (0.40\u20131.39) (TITAN) and 0.39 (0.19\u20130.78), 0.89 (0.69\u20131.16) and 0.81 (0.58\u20131.15) (SPARTAN) in patients aged &lt;65, 65\u201379 and \u226580 years. Regardless of age, apalutamide also maintained HRQoL and was tolerated well with a potential trend in rates of adverse events increasing with age. Limitations include post-hoc nature and variability in sample size of age groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Apalutamide plus ADT was an effective and well-tolerated option maintaining HRQoL in patients with mCSPC and nmCRPC regardless of age.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>TITAN (NCT02489318); SPARTAN (NCT01946204).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1038\/s41416-023-02492-8","type":"journal-article","created":{"date-parts":[[2023,11,11]],"date-time":"2023-11-11T08:02:03Z","timestamp":1699689723000},"page":"73-81","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN"],"prefix":"10.1038","volume":"130","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6455-5553","authenticated-orcid":false,"given":"John","family":"Shen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Chowdhury","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeraj","family":"Agarwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence I.","family":"Karsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Oudard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin A.","family":"Gartrell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Feyerabend","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2986-5617","authenticated-orcid":false,"given":"Fred","family":"Saad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher M.","family":"Pieczonka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim N.","family":"Chi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine D.","family":"Brookman-May","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendan","family":"Rooney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amitabha","family":"Bhaumik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon A.","family":"McCarthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine B.","family":"Bevans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneel D.","family":"Mundle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric J.","family":"Small","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew R.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie N.","family":"Graff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,11,11]]},"reference":[{"key":"2492_CR1","doi-asserted-by":"publisher","first-page":"2974","DOI":"10.1200\/JCO.19.00799","volume":"37","author":"AJ Armstrong","year":"2019","unstructured":"Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, et al. 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SC reports consultancy to Astellas Pharma, Bayer, Beigene, Clovis, Janssen-Cilag, Johnson & Johnson, Novartis and Sanofi; research funding (self) from Clovis; and honoraria from Astellas Pharma, Bayer, Beigene, Clovis, Janssen-Cilag, Johnson & Johnson, Novartis and Sanofi. NA reports consultancy to Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics and Seattle Genetics; and research funding to institution from Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, GlaxoSmithKline, Immunomedics, Janssen, Medivation, Merck, Nektar, New Link Genetics, Novartis, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda and Tracon. LIK reports consulting or advisory role for 3D Biopsy, Astellas, AstraZeneca, Bayer, Dendreon, Ferring, Janssen, Pfizer and Vaxiion; speakers\u2019 bureau for Astellas, Bayer, Janssen, Pfizer, and Clovis; honoraria from Astellas, Bayer, Janssen, Pfizer and Dendreon; stock or other ownership from Swan Valley Medical; research funding from Astellas, AstraZeneca, Bayer, BioXcel Therapeutics, Bristol Myers Squibb, BU Optics, CUSP, Dendreon, Epizyme, Exact Sciences, Ferring, FKD, Genentech\/Roche, GenomeDX, Genomic Health, Janssen, Merck, Myovant, Nucleix, OncoCell MDx, Pfizer, Pharmtech\/Very, Precision Med and QED; and travel, accommodations and expenses from Astellas, Bayer, Dendreon, Janssen and Pfizer. SO reports advisory roles for Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer and Sanofi; compensation for travel from Bayer, Bristol Myers Squibb, Eisai, Merck Sharp & Dohme, Novartis and Pfizer; honoraria from Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer and Sanofi; and research funding from Ipsen and Sanofi. BAG reports consulting fees from Blue Earth, Immunogen, Janssen, Pfizer and Sanofi. Susan Feyerabend has nothing to disclose. FS reports advisory roles for Astellas Pharma, AstraZeneca\/MedImmune, Bayer, Janssen Oncology and Sanofi; honoraria from AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Janssen Oncology and Sanofi; and research funding grants provided to his institution from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen Oncology, Pfizer and Sanofi. CMP reports consulting or advisory role for Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Dendreon, Janssen Oncology, Merck, Sun Pharma, Pfizer and Tolmar; speakers\u2019 bureau for Astellas Pharma, Bayer, Dendreon, Janssen Oncology, Merck, Myovant Sciences, Pfizer, Sun Pharma and Tolmar; honoraria from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Dendreon, Janssen, Merck, Myovant Sciences, Pfizer, Sun Pharma and Tolmar; and research funding from Advantagene, Astellas Pharma, AstraZeneca, Bayer, Dendreon, Innocrin Pharma, Janssen Oncology, Merck and Pfizer. KNC reports consultancy to Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Essa, Janssen, Novartis, Merck, Pfizer, Point Pharma, Roche and Sanofi; research funding to institution from Astellas, Janssen and Sanofi; and honoraria from Astellas, AstraZeneca, Bayer, Janssen, Merck and Pfizer. EJS reports advisory roles for Fortis and Janssen Oncology; compensation for travel from Janssen; stock and interest in Fortis and Harpoon Therapeutics; honoraria from Janssen; and research funding from Janssen and Merck Sharp & Dohme. MRS reports advisory roles for Amgen, Bayer, Janssen Oncology, Lilly, Novartis and Pfizer; compensation for travel from Amgen, Bayer, Janssen and Lilly; and research funding from Bayer, Gilead Sciences and Janssen Oncology. JNG reports an advisory role for Exelixis; compensation for travel from Bayer, Clovis Oncology and Merck Sharp & Dohme; patents, royalties and intellectual property with Oncoresponse: Exceptional Responders; honoraria from Astellas, Bayer, Janssen Oncology and Medivation; and research funding from Bristol Myers Squibb, Janssen Oncology, Medivation, Merck Sharp & Dohme and Sanofi. SDBM, BR, AB, SAMC, KBB and SDM are employees of Janssen Research & Development and may hold stock in Johnson & Johnson. AB also reports stock ownership of AbbVie.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Review boards at all participating institutions approved the TITAN and SPARTAN studies, which were conducted in according to current International Council for Harmonisation Guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. All patients provided written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}