Apalutamide treatment preserves health-related quality of life (HRQoL) while lowering the risk of metastasis among men with asymptomatic high-risk nonmetastatic castration-resistant prostate cancer (nmCRPC), according to a new study. It also delays the decrease in HRQoL associated with symptomatic progression.
“It is critical to delay the onset of metastasis in patients with nmCRPC,” lead investigator Fred Saad, MD, FRCS, Professor and Chairman of Urology at the University of Montreal Hospital Center, told Renal & Urology News. “These data from the pivotal SPARTAN study found apalutamide, in combination with current standard of care, can prolong median metastasis-free survival, while preserving HRQoL, which is a significant advance for patients with nmCRPC and for clinicians who treat them.”
He and his colleagues analyzed data from the SPARTAN randomized, placebo-controlled phase 3 trial in which 1207 asymptomatic men with nmCRPC at high risk of metastases were randomly assigned to receive apalutamide (806 men) or placebo (401 men) in addition to androgen deprivation therapy. The trial demonstrated that apalutamide recipients had significantly improved metastasis-free survival compared with men in the placebo arm. The median follow-up for overall survival was 20.3 months. Based on the SPARTAN trial, the FDA on February 14 approved apalutamide for the treatment of patients with nmCRPC.
Dr Saad’s team evaluated HRQoL using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L questionnaires. FACT-P is a 39-item questionnaire developed and validated specifically for patients with prostate cancer (PCa). FACT-P has 5 subscales (physical wellbeing, social and family wellbeing, emotion wellbeing, functional wellbeing, and PCa subscale. The scores from these subscales can be added together to arrive at a single overall score, which ranges from 0 to 156. Higher FACT-P total and subscale scores indicate a higher HRQOL. The EQ-FD-3L has 5 items that ask patients to rate their perceived health state at the time they are filling out the questionnaire. The questionnaire asks about mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Scores range from 0 to 3, with 1 indicating no problems, 2 indicating some problems, and 3 indicating extreme problems.
Patients filled out these questionnaires at baseline, day 1 of cycle 1 (before dose), day 1 of treatment cycles 1–6, day 1 of every 2 cycles from cycles 7–13, and day 1 of every 4 cycles thereafter.
Group mean scores for patient-reported outcomes show that overall HRQoL was maintained from baseline after start of treatment with apalutamide until treatment cycle 29 for those who remained on therapy, the investigators reported online ahead of print in Lancet Oncology. During a median treatment duration of 16.9 months, “mean changes from baseline in the FACT-P subscales were similar in both study arms, indicating that the addition of apalutamide to androgen deprivation therapy did not result in a decrease in HRQoL.”
The researchers also stated: “Findings from the EQ-5D-3L health utility index indicated that patients believed their abilities to walk about, wash and dress themselves, and perform their usual activities were maintained after initiation of study treatment.”
In addition, patients who received apalutamide had a similar HRQoL after development of metastasis as those in the placebo group. “A decrease in HRQoL was associated with symptomatic progressive disease in both treatment groups.”
“Patient-reported outcomes data are gaining importance as health care systems place greater emphasis on patient experience with treatment,” Dr. Saad said. “Amongst men in this patient population, maintaining quality of life is an important endpoint. … The results published are extremely reassuring because as clinicians, we can positively alter the course of one’s prostate cancer journey, while preserving HRQoL.”
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; published online ahead of print.