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Enzalutamide and Su...
Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer
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Sternberg, Cora N. (författare)
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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, Anders (bidragsgivare)
- Umeå universitet,Institutionen för kirurgisk och perioperativ vetenskap
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- Ljungberg, Börje, Professor, 1949- (bidragsgivare)
- Umeå universitet,Urologi och andrologi
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(creator_code:org_t)
- Massachusetts Medical Society, 2020
- 2020
- Engelska.
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Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 382:23, s. 2197-2206
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
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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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visa fler...
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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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Sugg, Jennifer
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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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visa färre...
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