PATIENT-REPORTED OUTCOMES FOR HRQoL1-6
Patients maintained health-related quality of life (HRQoL) while taking ERLEADA® with ADT in both the TITAN and SPARTAN studies1-6
HRQoL based on patient-reported outcomes is not reported in the ERLEADA® Prescribing Information. HRQoL should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.
In the TITAN study
Pre-specified exploratory endpoint
HRQoL WAS MAINTAINED WITH ERLEADA® + ADT AFTER A MEDIAN FOLLOW-UP OF 44.0 MONTHS
Analysis of change from baseline in the FACT-P total score showed no substantial between-group differences.*1
Mean Change From Baseline in FACT-P Total Score
*The FACT-P patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall HRQoL in the TITAN study. The FACT-P is a 39-item questionnaire developed and validated specifically in patients with prostate cancer. The scores for 5 FACT-P subscales (physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) can be added together to make a single overall score that ranges from 0-156. Higher values of FACT-P total and all subscales indicate a higher HRQoL. In the TITAN study, the FACT-P was completed during Cycles 1 to 7, then every other cycle until the end of treatment, and at months 4, 8, and 12 in follow-up. Each treatment cycle was 28 days.2,3
POST HOC ANALYSIS OF PAIN AND FATIGUE IN THE TITAN STUDY4
Time to Deterioration in Pain†
Time to Deterioration in Fatigue§
†Based on individual questions from Brief Pain Inventory-Short Form administered to patients (TITAN study).4
‡P<0.05 for ERLEADA® vs placebo.4
§Based on individual questions from Brief Fatigue Inventory administered to patients (TITAN study).4
HRQoL based on patient-reported outcomes is not reported in the ERLEADA® Prescribing Information. HRQoL should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.
In the SPARTAN study
Pre-specified exploratory endpoint
HRQoL WAS MAINTAINED WITH ERLEADA® + ADT AFTER A MEDIAN FOLLOW-UP OF 52.0 MONTHS.
IN PATIENTS RECEIVING ADT ALONE, HRQoL DECLINED AFTER APPROXIMATELY 1 YEAR*5
Mean Change From Baseline in FACT-P Total Score
*The FACT-P patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall HRQoL in the SPARTAN study. The FACT-P is a 39-item questionnaire developed and validated specifically in patients with prostate cancer. The scores for 5 FACT-P subscales (physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) can be added together to make a single overall score that ranges from 0-156. Higher values of FACT-P total and all subscales indicate a higher HRQoL. The FACT-P was given and collected during the treatment phase at baseline, on Day 1 of Cycle 1 (before dose), Day 1 of Cycles 2-6, Day 1 of every 2 cycles starting at Cycle 7 to Cycle 13, and then Day 1 of every 4 cycles, unless otherwise specified. Each treatment cycle was 28 days.6
Post hoc analysis
ENERGY LEVELS WERE MAINTAINED WHILE TAKING ERLEADA® + ADT†6
Analysis of answers to the question from the FACT-P physical well-being domain,
“I have a lack of energy”‡6
†The Functional Assessment of Cancer Therapy-Prostate (FACT-P) patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall HRQoL. Patient-reported outcome data are shown for 29 cycles, approximately 25.8 months from the start of treatment; data from subsequent treatment cycles were not interpretable because fewer than 20 patients remained in the placebo group. Generally, the total and subscale scores for FACT-P were maintained with ERLEADA® from baseline until treatment Cycle 29. There were similar data showing this preservation of HRQoL from baseline EQ-5D-3L. Maintenance of HRQoL was also observed with placebo.5 Patients were required to complete the two paper, self-administered patient-reported outcome questionnaires before any other interventions or examinations on the day of the clinic visit. FACT-P and EQ-5D-3L were given and collected during the treatment phase at baseline, on Day 1 of Cycle 1 (before dose), Day 1 of Cycles 2–6, Day 1 of every two cycles starting at Cycle 7 to Cycle 13, then Day 1 of every four cycles, unless otherwise specified. This frequency enabled assessment of treatment tolerability and patients’ HRQoL over time.6
‡The results were consistent across all FACT-P subscales.
Consistent efficacy demonstrated in 2 pivotal trials
ADT = androgen deprivation therapy; BFI = Brief Fatigue Inventory; FACT-P = Functional Assessment of Cancer Therapy-Prostate; HRQoL = health-related quality of life; NE = not estimable; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509; TITAN = Targeted Investigational Treatment Analysis of Novel Anti-androgen.
REFERENCES:
- Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol. 2021;39(20):2294-2303.
- Agarwal N, McQuarrie K, Bjartell A, et al; TITAN Investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019;20(11):1518-1530.
- Agarwal N, McQuarrie K, Bjartell A, et al; TITAN Investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Supplement. Lancet Oncol. 2019;20(11):1518-1530.
- Agarwal N, McQuarrie K, Bjartell A, et al. Apalutamide plus androgen deprivation therapy for metastatic castration-sensitive prostate cancer: analysis of pain and fatigue in the phase 3 TITAN study. J Urol. 2021;206:914-923.
- Oudard S, Hadaschik B, Saad F, et al. Health-related quality of life at the SPARTAN final analysis of apalutamide for nonmetastatic castration-resistant prostate cancer patients receiving androgen deprivation therapy. Eur Urol Focus. Published August 31, 2021. doi:10.1016/j.euf.2021.08.005
- Saad F, Cella D, Basch E, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(10):1404-1416.