Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study
| العنوان: | Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study |
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| المؤلفون: | Robert Given, Branko Miladinovic, Neeraj Agarwal, Simon Chowdhury, Ethan Basch, Mustafa Ozguroglu, Anders Bjartell, Byung Ha Chung, Dingwei Ye, Álvaro Juárez Soto, Angela Lopez-Gitlitz, Kim N. Chi, Axel S. Merseburger, Hirotsugu Uemura, Andrea J. Pereira de Santana Gomes, Kelly McQuarrie |
| المصدر: | Journal of Urology. 206:914-923 |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Double-Blind, Oncology, medicine.medical_specialty, Urology, Abiraterone Acetate, prostatic neoplasms, Androgen deprivation therapy, neoplasm metastasis, Chemotherapy-Naive Patients, Prostate cancer, chemistry.chemical_compound, Quality of life, Prostate, Internal medicine, medicine, In patient, apalutamide, Patient, business.industry, Apalutamide, Men, Exploratory analysis, medicine.disease, Castration-sensitive prostate cancer, medicine.anatomical_structure, quality of life, chemistry, Prednisone, business |
| الوصف: | Purpose: We performed an exploratory analysis of prostate cancer-related pain and fatigue on health-related quality of life in patients with metastatic castration-sensitive prostate cancer receiving apalutamide (240 mg/day) or placebo, with continuous androgen deprivation therapy (ADT), in the phase 3, randomized, double-blind, placebo controlled TITAN trial (NCT02489318). Materials and Methods: Patient-reported outcomes for pain and fatigue were evaluated using the Brief Pain Inventory-Short Form and Brief Fatigue Inventory. Time to deterioration (TTD) was estimated by Kaplan-Meier method; hazard ratios and 95% confidence intervals were calculated using Cox proportional hazards model. General estimating equations for logistic regression estimated treatment-related differences in the likelihood of worsening pain or fatigue. Results: Compliance for completing the Brief Pain Inventory-Short Form and Brief Fatigue Inventory was high (96% to 97%) in the first year. Median followup times were similar between treatments (19 to 22 months). Median pain TTD was longer with apalutamide than placebo for pain at its least in the last 24 hours (28.7 vs 21.8 months, respectively; p=0.0146), pain interfered with mood (not estimable vs 22.4 months; p=0.0017), pain interfered with walking ability (28.7 vs 20.2 months; p=0.0027), pain interfered with relations (not estimable vs 23.0 months; p=0.0139) and pain interfered with sleep (28.7 vs 20.9 months; p=0.0167). Likelihood for fatigue and worsening fatigue were similar between groups. Conclusions: Patients with metastatic castration-sensitive prostate cancer receiving apalutamide plus ADT vs placebo plus ADT reported consistently favorable TTD of pain. No difference for change in fatigue was observed with apalutamide vs placebo. Janssen Research Development; Janssen Global Services, LLC The authors would like to thank the patients who participated in this study and their families, as well as the investigators, study coordinators, study teams and nurses. The TITAN study was funded by Janssen Research & Development. Editorial assistance was provided by Patricia McChesney, PhD, of Parexel, with funding from Janssen Global Services, LLC. |
| تدمد: | 1527-3792 0022-5347 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::50de200c9291804db7814f8d66e5065e https://doi.org/10.1097/ju.0000000000001841 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....50de200c9291804db7814f8d66e5065e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15273792 00225347 |
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