دورية أكاديمية
Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study
| العنوان: | Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study |
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| المساهمون: | Neeraj Agarwal, Kelly McQuarrie, Anders Bjartell, Simon Chowdhury, Andrea J Pereira de Santana Gomes, Byung Ha Chung, Mustafa 횜zg체ro휓lu, Axel S Merseburger, Hirotsugu Uemura, Dingwei Ye, Robert Given, David Cella, Ethan Basch, Branko Miladinovic, Lindsay Dearden, Kris Deprince, Vahid Naini, Angela Lopez-Gitlitz, Kim N Chi, Chung, Byung Ha |
| بيانات النشر: | Lancet Pub. Group |
| سنة النشر: | 2019 |
| الوصف: | BACKGROUND: In the phase 3 TITAN study, the addition of apalutamide to androgen deprivation therapy (ADT) significantly improved the primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer. We aimed to assess health-related quality of life (HRQOL) in TITAN, including pain and fatigue. METHODS: In this randomised, placebo-controlled, double-blind, phase 3 study, patients with metastatic castration-sensitive prostate cancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1 were randomly assigned (1:1), using an interactive web response system, to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo. Previous localised disease treatment or previous docetaxel for metastatic castration-sensitive prostate cancer were allowed. Randomisation was stratified by Gleason score at diagnosis, region, and previous docetaxel treatment. Randomisation was done using randomly permuted blocks (block size of four). Investigators, research staff, sponsor study team, and patients were masked to the identities of test and control treatments. Patient-reported outcomes were prespecified exploratory endpoints and were the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L). BPI and BFI were completed for 7 consecutive days (days -6 to 1 inclusive of each cycle visit), then at months 4, 8, and 12 in follow-up. FACT-P and EQ-5D-5L were completed during cycles 1-7, then every other cycle until the end of treatment, and at months 4, 8, and 12 in follow-up. Analyses were based on the intention-to-treat population. Missing patient-reported outcome assessments were calculated as the expected number of ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1470-2045 1474-5488 |
| العلاقة: | LANCET ONCOLOGY; J02154; OAK-2019-06599; https://ir.ymlib.yonsei.ac.kr/handle/22282913/174554Test; https://www.sciencedirect.com/science/article/pii/S1470204519306205Test; T201904865; LANCET ONCOLOGY, Vol.20(11) : 1518-1530, 2019 |
| DOI: | 10.1016/S1470-2045(19)30620-5 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(19)30620-5 https://ir.ymlib.yonsei.ac.kr/handle/22282913/174554Test https://www.sciencedirect.com/science/article/pii/S1470204519306205Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.B90694D8 |
| قاعدة البيانات: | BASE |
| تدمد: | 14702045 14745488 |
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| DOI: | 10.1016/S1470-2045(19)30620-5 |