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WFRF:(Logothetis Christopher J.)
 

Search: WFRF:(Logothetis Christopher J.) > (2015) > Abiraterone acetate...

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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006799naa a2200781 4500
001oai:lup.lub.lu.se:5efd6db3-607a-4d21-9c64-cecf189d59d9
003SwePub
008190628s2015 | |||||||||||000 ||eng|
0247 a https://lup.lub.lu.se/record/5efd6db3-607a-4d21-9c64-cecf189d59d92 URI
0247 a https://doi.org/10.1016/S1470-2045(14)71205-72 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
1001 a Ryan, Charles Ju University of California, San Francisco4 aut
2451 0a Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302) : final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study
264 1c 2015
300 a 9 s.
520 a BACKGROUND: Abiraterone acetate plus prednisone significantly improved radiographic progression-free survival compared with placebo plus prednisone in men with chemotherapy-naive castration-resistant prostate cancer at the interim analyses of the COU-AA-302 trial. Here, we present the prespecified final analysis of the trial, assessing the effect of abiraterone acetate plus prednisone on overall survival, time to opiate use, and use of other subsequent therapies.METHODS: In this placebo-controlled, double-blind, randomised phase 3 study, 1088 asymptomatic or mildly symptomatic patients with chemotherapy-naive prostate cancer stratified by Eastern Cooperative Oncology performance status (0 vs 1) were randomly assigned with a permuted block allocation scheme via a web response system in a 1:1 ratio to receive either abiraterone acetate (1000 mg once daily) plus prednisone (5 mg twice daily; abiraterone acetate group) or placebo plus prednisone (placebo group). Coprimary endpoints were radiographic progression-free survival and overall survival analysed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, number NCT00887198.FINDINGS: At a median follow-up of 49.2 months (IQR 47.0-51.8), 741 (96%) of the prespecified 773 death events for the final analysis had been observed: 354 (65%) of 546 patients in the abiraterone acetate group and 387 (71%) of 542 in the placebo group. 238 (44%) patients initially receiving prednisone alone subsequently received abiraterone acetate plus prednisone as crossover per protocol (93 patients) or as subsequent therapy (145 patients). Overall, 365 (67%) patients in the abiraterone acetate group and 435 (80%) in the placebo group received subsequent treatment with one or more approved agents. Median overall survival was significantly longer in the abiraterone acetate group than in the placebo group (34.7 months [95% CI 32.7-36.8] vs 30.3 months [28.7-33.3]; hazard ratio 0.81 [95% CI 0.70-0.93]; p=0.0033). The most common grade 3-4 adverse events of special interest were cardiac disorders (41 [8%] of 542 patients in the abiraterone acetate group vs 20 [4%] of 540 patients in the placebo group), increased alanine aminotransferase (32 [6%] vs four [<1%]), and hypertension (25 [5%] vs 17 [3%]).INTERPRETATION: In this randomised phase 3 trial with a median follow-up of more than 4 years, treatment with abiraterone acetate prolonged overall survival compared with prednisone alone by a margin that was both clinically and statistically significant. These results further support the favourable safety profile of abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer.FUNDING: Janssen Research & Development.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653 a Aged
653 a Androstenes/therapeutic use
653 a Antineoplastic Agents, Hormonal/therapeutic use
653 a Antineoplastic Combined Chemotherapy Protocols
653 a Bone Neoplasms/drug therapy
653 a Disease Progression
653 a Double-Blind Method
653 a Follow-Up Studies
653 a Humans
653 a Male
653 a Neoplasm Staging
653 a Prednisone/therapeutic use
653 a Prognosis
653 a Prostatic Neoplasms, Castration-Resistant/drug therapy
653 a Survival Rate
7001 a Smith, Matthew Ru Massachusetts General Hospital4 aut
7001 a Fizazi, Karimu University of Paris-Saclay4 aut
7001 a Saad, Fredu University Of Quebec In Montreal4 aut
7001 a Mulders, Peter F Au Radboud University Medical Center4 aut
7001 a Sternberg, Cora Nu Azienda Ospedaliera San Camillo Forlanini4 aut
7001 a Miller, Kurtu Charité - University Medicine Berlin4 aut
7001 a Logothetis, Christopher Ju University of Texas4 aut
7001 a Shore, Neal Du Carolina Urologic Research Center4 aut
7001 a Small, Eric Ju University of California, San Francisco4 aut
7001 a Carles, Joanu Vall d'Hebron University Hospital4 aut
7001 a Flaig, Thomas Wu University of Colorado4 aut
7001 a Taplin, Mary-Ellenu Dana-Farber Cancer Institute4 aut
7001 a Higano, Celestia Su University of Washington, Seattle4 aut
7001 a de Souza, Paulu Ingham Institute for Applied Medical Research,Western Sydney University4 aut
7001 a de Bono, Johann Su Royal Marsden Hospital, Sutton4 aut
7001 a Griffin, Thomas Wu Janssen Pharmaceuticals, US4 aut
7001 a De Porre, Peteru Janssen Research & Development, Belgium4 aut
7001 a Yu, Margaret Ku Janssen Pharmaceuticals, US4 aut
7001 a Park, Youn Cu Janssen Pharmaceuticals, US4 aut
7001 a Li, Jinhuiu Janssen Pharmaceuticals, US4 aut
7001 a Kheoh, Thianu Janssen Pharmaceuticals, US4 aut
7001 a Naini, Vahidu Janssen Pharmaceuticals, US4 aut
7001 a Molina, Arturou Janssen Pharmaceuticals, US4 aut
7001 a Rathkopf, Dana Eu Memorial Sloan-Kettering Cancer Center4 aut
7001 a Bjartell, Andersu Lund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,Urological cancer, Malmö,Lund University Research Groups4 cre0 (Swepub:lu)kir-abj
7102 a University of California, San Franciscob Massachusetts General Hospital4 org
7102 a COU-AA-302 Investigators
7730 t The Lancet Oncologyg 16:2, s. 60-152q 16:2<60-152x 1474-5488
8564 u http://dx.doi.org/10.1016/S1470-2045(14)71205-7y FULLTEXT
8564 8u https://lup.lub.lu.se/record/5efd6db3-607a-4d21-9c64-cecf189d59d9
8564 8u https://doi.org/10.1016/S1470-2045(14)71205-7

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