دورية أكاديمية
Abiraterone acetate plus prednisone in patients with newly Croatia& diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial
| العنوان: | Abiraterone acetate plus prednisone in patients with newly Croatia& diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial |
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| المؤلفون: | Fizazi, Karim, NamPhuong Tran, Fein, Luis, Matsubara, Nobuaki, Rodriguez-Antolin, Alfredo, Alekseev, Boris Y., Chi, Kim N., Özgüroğlu, Mustafa |
| المساهمون: | İÜC, Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü |
| بيانات النشر: | Elsevier Science Inc |
| سنة النشر: | 2019 |
| الوصف: | MUSTAFA, OZGUROGLU/0000-0002-8417-8628; Alekseev, Boris/0000-0002-3398-4128 ; WOS:000466380000061 ; PubMed ID: 30987939 ; Background In the interim analyses of the LATITUDE study, the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) led to a significant improvement in overall survival and radiographic progression-free survival compared with placebos plus ADT in men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC). Here, we present long-term survival outcomes and safety of abiraterone acetate plus prednisone and ADT from the final analysis of the LATITUDE study. Methods This is a multicentre, randomised, double-blind, phase 3 trial done at 235 sites in 34 countries. Eligible patients (men aged >= 18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of >= 8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis). Patients were randomly assigned (1:1) to receive abiraterone acetate (1000 mg) once daily orally plus prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo group); each treatment cycle was 28 days. Randomisation was done by a centralised interactive web response system in a country-by-country scheme using permuted block randomisation, stratified by presence of visceral disease and ECOG performance status. The coprimary endpoint of overall survival was assessed in the intention-to-treat population. This study is registered at ClinicalTrials.gov , number NCT01715285 and is complete. Findings Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations. 1199 patients were randomly assigned to either the abiraterone acetate plus ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1470-2045 1474-5488 |
| العلاقة: | Lancet Oncology; Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı; https://doi.org/10.1016/S1470-2045Test(19)30082-8; https://hdl.handle.net/20.500.12831/1417Test; 20; 686; 700 |
| DOI: | 10.1016/S1470-2045(19)30082-8 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(19)30082-8 https://doi.org/20.500.12831/1417Test https://hdl.handle.net/20.500.12831/1417Test |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.C1989000 |
| قاعدة البيانات: | BASE |
| تدمد: | 14702045 14745488 |
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| DOI: | 10.1016/S1470-2045(19)30082-8 |