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      Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

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          Abstract

          Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined.

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          Most cited references8

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          Is Open Access

          Management of Patients with Advanced Prostate Cancer: The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017

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            Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy--Prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer.

            To determine clinically meaningful changes (CMCs) for the Functional Assessment of Cancer Therapy-Prostate (FACT-P). We obtained data from a Phase III trial of atrasentan in metastatic hormone-refractory prostate cancer patients (n = 809). We determined anchor-based differences using Karnofsky Performance Status (KPS), bone alkaline phosphatase (BAP), hemoglobin, time to disease progression (TTP), adverse events (AE), and survival. One-third and one-half standard deviation and standard error of measurement (SEM) were used as distribution-based criteria for CMCs. Comparison across baseline FACT-P domains and derived scales [FACT-P total score, Trial Outcome Index (TOI) score, prostate cancer subscale (PCS) score, pain-related score, and FACT Advanced Prostate Symptom Index (FAPSI)] were conducted for KPS, BAP, and hemoglobin using Student's t tests. Twelve-week change scores were compared for TTP, AE, and survival using ANCOVA. CMCs were estimated as 6 to 10 for FACT-P total score, 5 to 9 for FACT-P TOI score, 2 to 3 for FACT-P PCS, 1 to 2 for the 4 PCS pain-related questions, and 2 to 3 for FAPSI. CMCs were also estimated using distribution-based criteria. Kappa statistics were computed to determine the degree of correspondence between the recommended guideline of 1.0 SEM and empirically derived standards. Most of the kappas for health-related quality of life domains and SEM standards had "substantial" to "almost perfect" concordance. The significant relationship between clinical and quality of life data provides support for the use of CMCs to increase interpretability of FACT-P scores.
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              Survival benefit, disease progression and quality-of-life outcomes of abiraterone acetate plus prednisone versus docetaxel in metastatic hormone-sensitive prostate cancer: A network meta-analysis

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                Author and article information

                Journal
                New England Journal of Medicine
                N Engl J Med
                Massachusetts Medical Society
                0028-4793
                1533-4406
                May 31 2019
                May 31 2019
                Affiliations
                [1 ]From BC Cancer and Vancouver Prostate Centre, Vancouver, Canada (K.N.C.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); Skåne University Hospital, Lund University, Malmö, Sweden (A.B.); Yonsei University College of Medicine and Gangnam Severance Hospital, Seoul, South Korea (B.H.C.); Liga Norte Riograndense Contra o Câncer, Natal, Brazil (A.J.P.S.G.); Urology of Virginia, Eastern Virginia Medical School, Norfolk (R.G.); Hospital Universitario de Jerez de la Frontera, Cadiz, Spain ...
                Article
                10.1056/NEJMoa1903307
                31150574
                26780e53-833c-46ac-aeba-64f05b9675ef
                © 2019

                http://www.nejmgroup.org/legal/terms-of-use.htm

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