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Enzalutamide and Su...
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Sternberg, Cora N.
(författare)
Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer
- Artikel/kapitelEngelska2020
Förlag, utgivningsår, omfång ...
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Massachusetts Medical Society,2020
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printrdacarrier
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LIBRIS-ID:oai:DiVA.org:umu-176925
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-176925URI
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https://doi.org/10.1056/NEJMoa2003892DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:art swepub-publicationtype
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Background: Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.Methods: In this double-blind, phase 3 trial, men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy were randomly assigned (in a 2:1 ratio) to receive enzalutamide at a dose of 160 mg or placebo once daily. Overall survival was assessed with a group sequential testing procedure and an O’Brien–Fleming–type alpha-spending function.Results: As of October 15, 2019, a total of 288 of 933 patients (31%) in the enzalutamide group and 178 of 468 (38%) in the placebo group had died. Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P=0.001). The exposure-adjusted rate of adverse events of grade 3 or higher was 17 per 100 patient-years in the enzalutamide group and 20 per 100 patient-years in the placebo group. Adverse events in the enzalutamide group were consistent with those previously reported for enzalutamide; the most frequently reported events were fatigue and musculoskeletal events.Conclusions: Enzalutamide plus androgen-deprivation therapy resulted in longer median overall survival than placebo plus androgen-deprivation therapy among men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level. The risk of death associated with enzalutamide was 27% lower than with placebo. Adverse events were consistent with the established safety profile of enzalutamide. (Funded by Pfizer and Astellas Pharma; PROSPER ClinicalTrials.gov number, NCT02003924.)
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Fizazi, Karim
(författare)
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Saad, Fred
(författare)
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Shore, Neal D.
(författare)
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De Giorgi, Ugo
(författare)
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Penson, David F.
(författare)
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Ferreira, Ubirajara
(författare)
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Efstathiou, Eleni
(författare)
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Madziarska, Katarzyna
(författare)
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Kolinsky, Michael P.
(författare)
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Cubero, Daniel I. G.
(författare)
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Noerby, Bettina
(författare)
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Zohren, Fabian
(författare)
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Lin, Xun
(författare)
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Modelska, Katharina
(författare)
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Sugg, Jennifer
(författare)
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Steinberg, Joyce
(författare)
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Hussain, Maha
(författare)
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Bjartell, AndersUmeå universitet,Institutionen för kirurgisk och perioperativ vetenskap(Swepub:umu)anbj0196
(bidragsgivare)
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Ljungberg, Börje,Professor,1949-Umeå universitet,Urologi och andrologi(Swepub:umu)bolj0001
(bidragsgivare)
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Umeå universitetInstitutionen för kirurgisk och perioperativ vetenskap
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:New England Journal of Medicine: Massachusetts Medical Society382:23, s. 2197-22060028-47931533-4406
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Sternberg, Cora ...
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Fizazi, Karim
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Saad, Fred
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Shore, Neal D.
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De Giorgi, Ugo
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Penson, David F.
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Ferreira, Ubiraj ...
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Efstathiou, Elen ...
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Madziarska, Kata ...
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Kolinsky, Michae ...
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Cubero, Daniel I ...
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Noerby, Bettina
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Zohren, Fabian
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Lin, Xun
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Modelska, Kathar ...
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Steinberg, Joyce
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Hussain, Maha
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Bjartell, Anders
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Ljungberg, Börje ...
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