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Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer

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Harvard

Smith, MR, Saad, F, Chowdhury, S, Oudard, S, Hadaschik, BA, Graff, JN, Olmos, D, Mainwaring, PN, Lee, JY, Uemura, H, Lopez-Gitlitz, A, Trudel, GC, Espina, BM, Shu, Y, Park, YC, Rackoff, WR, Yu, MK, Small, EJ, SPARTAN Investigators & Brasso, K 2018, 'Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer' The New England journal of medicine, bind 378, nr. 15, s. 1408-1418. https://doi.org/10.1056/NEJMoa1715546

APA

Smith, M. R., Saad, F., Chowdhury, S., Oudard, S., Hadaschik, B. A., Graff, J. N., ... Brasso, K. (2018). Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. The New England journal of medicine, 378(15), 1408-1418. https://doi.org/10.1056/NEJMoa1715546

CBE

Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ, SPARTAN Investigators, Brasso K. 2018. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. The New England journal of medicine. 378(15):1408-1418. https://doi.org/10.1056/NEJMoa1715546

MLA

Vancouver

Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN o.a. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. The New England journal of medicine. 2018 apr 12;378(15):1408-1418. https://doi.org/10.1056/NEJMoa1715546

Author

Smith, Matthew R ; Saad, Fred ; Chowdhury, Simon ; Oudard, Stéphane ; Hadaschik, Boris A ; Graff, Julie N ; Olmos, David ; Mainwaring, Paul N ; Lee, Ji Youl ; Uemura, Hiroji ; Lopez-Gitlitz, Angela ; Trudel, Géralyn C ; Espina, Byron M ; Shu, Youyi ; Park, Youn C ; Rackoff, Wayne R ; Yu, Margaret K ; Small, Eric J ; SPARTAN Investigators ; Brasso, Klaus. / Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. I: The New England journal of medicine. 2018 ; Bind 378, Nr. 15. s. 1408-1418.

Bibtex

@article{946a853542ec4a3ebb1a18d11eb4e950,
title = "Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer",
abstract = "BACKGROUND: Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis.METHODS: We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide (240 mg per day) or placebo. All the patients continued to receive androgen-deprivation therapy. The primary end point was metastasis-free survival, which was defined as the time from randomization to the first detection of distant metastasis on imaging or death.RESULTS: A total of 1207 men underwent randomization (806 to the apalutamide group and 401 to the placebo group). In the planned primary analysis, which was performed after 378 events had occurred, median metastasis-free survival was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (hazard ratio for metastasis or death, 0.28; 95{\%} confidence interval [CI], 0.23 to 0.35; P<0.001). Time to symptomatic progression was significantly longer with apalutamide than with placebo (hazard ratio, 0.45; 95{\%} CI, 0.32 to 0.63; P<0.001). The rate of adverse events leading to discontinuation of the trial regimen was 10.6{\%} in the apalutamide group and 7.0{\%} in the placebo group. The following adverse events occurred at a higher rate with apalutamide than with placebo: rash (23.8{\%} vs. 5.5{\%}), hypothyroidism (8.1{\%} vs. 2.0{\%}), and fracture (11.7{\%} vs. 6.5{\%}).CONCLUSIONS: Among men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. (Funded by Janssen Research and Development; SPARTAN ClinicalTrials.gov number, NCT01946204 .).",
keywords = "Adenocarcinoma, Aged, Aged, 80 and over, Androgen Antagonists, Disease Progression, Disease-Free Survival, Double-Blind Method, Exanthema, Humans, Male, Middle Aged, Neoplasm Metastasis, Proportional Hazards Models, Prostate-Specific Antigen, Prostatic Neoplasms, Castration-Resistant, Thiohydantoins, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Smith, {Matthew R} and Fred Saad and Simon Chowdhury and St{\'e}phane Oudard and Hadaschik, {Boris A} and Graff, {Julie N} and David Olmos and Mainwaring, {Paul N} and Lee, {Ji Youl} and Hiroji Uemura and Angela Lopez-Gitlitz and Trudel, {G{\'e}ralyn C} and Espina, {Byron M} and Youyi Shu and Park, {Youn C} and Rackoff, {Wayne R} and Yu, {Margaret K} and Small, {Eric J} and {SPARTAN Investigators} and Klaus Brasso",
year = "2018",
month = "4",
day = "12",
doi = "10.1056/NEJMoa1715546",
language = "English",
volume = "378",
pages = "1408--1418",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "15",

}

RIS

TY - JOUR

T1 - Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer

AU - Smith, Matthew R

AU - Saad, Fred

AU - Chowdhury, Simon

AU - Oudard, Stéphane

AU - Hadaschik, Boris A

AU - Graff, Julie N

AU - Olmos, David

AU - Mainwaring, Paul N

AU - Lee, Ji Youl

AU - Uemura, Hiroji

AU - Lopez-Gitlitz, Angela

AU - Trudel, Géralyn C

AU - Espina, Byron M

AU - Shu, Youyi

AU - Park, Youn C

AU - Rackoff, Wayne R

AU - Yu, Margaret K

AU - Small, Eric J

AU - SPARTAN Investigators

A2 - Brasso, Klaus

PY - 2018/4/12

Y1 - 2018/4/12

N2 - BACKGROUND: Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis.METHODS: We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide (240 mg per day) or placebo. All the patients continued to receive androgen-deprivation therapy. The primary end point was metastasis-free survival, which was defined as the time from randomization to the first detection of distant metastasis on imaging or death.RESULTS: A total of 1207 men underwent randomization (806 to the apalutamide group and 401 to the placebo group). In the planned primary analysis, which was performed after 378 events had occurred, median metastasis-free survival was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (hazard ratio for metastasis or death, 0.28; 95% confidence interval [CI], 0.23 to 0.35; P<0.001). Time to symptomatic progression was significantly longer with apalutamide than with placebo (hazard ratio, 0.45; 95% CI, 0.32 to 0.63; P<0.001). The rate of adverse events leading to discontinuation of the trial regimen was 10.6% in the apalutamide group and 7.0% in the placebo group. The following adverse events occurred at a higher rate with apalutamide than with placebo: rash (23.8% vs. 5.5%), hypothyroidism (8.1% vs. 2.0%), and fracture (11.7% vs. 6.5%).CONCLUSIONS: Among men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. (Funded by Janssen Research and Development; SPARTAN ClinicalTrials.gov number, NCT01946204 .).

AB - BACKGROUND: Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis.METHODS: We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide (240 mg per day) or placebo. All the patients continued to receive androgen-deprivation therapy. The primary end point was metastasis-free survival, which was defined as the time from randomization to the first detection of distant metastasis on imaging or death.RESULTS: A total of 1207 men underwent randomization (806 to the apalutamide group and 401 to the placebo group). In the planned primary analysis, which was performed after 378 events had occurred, median metastasis-free survival was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (hazard ratio for metastasis or death, 0.28; 95% confidence interval [CI], 0.23 to 0.35; P<0.001). Time to symptomatic progression was significantly longer with apalutamide than with placebo (hazard ratio, 0.45; 95% CI, 0.32 to 0.63; P<0.001). The rate of adverse events leading to discontinuation of the trial regimen was 10.6% in the apalutamide group and 7.0% in the placebo group. The following adverse events occurred at a higher rate with apalutamide than with placebo: rash (23.8% vs. 5.5%), hypothyroidism (8.1% vs. 2.0%), and fracture (11.7% vs. 6.5%).CONCLUSIONS: Among men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. (Funded by Janssen Research and Development; SPARTAN ClinicalTrials.gov number, NCT01946204 .).

KW - Adenocarcinoma

KW - Aged

KW - Aged, 80 and over

KW - Androgen Antagonists

KW - Disease Progression

KW - Disease-Free Survival

KW - Double-Blind Method

KW - Exanthema

KW - Humans

KW - Male

KW - Middle Aged

KW - Neoplasm Metastasis

KW - Proportional Hazards Models

KW - Prostate-Specific Antigen

KW - Prostatic Neoplasms, Castration-Resistant

KW - Thiohydantoins

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1056/NEJMoa1715546

DO - 10.1056/NEJMoa1715546

M3 - Journal article

VL - 378

SP - 1408

EP - 1418

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 15

ER -

ID: 53667802