Neeraj Agarwal, MD, discusses the health-related quality of life and patient-reported outcomes in the TITAN trial of apalutamide versus placebo patients with metastatic castration-sensitive prostate cancer.
Neeraj Agarwal, MD, a professor in the Division of Oncology, Department of Medicine, at the University of Utah School of Medicine and senior director for Clinical Research Innovation at Huntsman Cancer Institute, discusses the health-related quality of life (HRQOL) and patient-reported outcomes (PROs) in the TITAN trial (NCT02489318) of apalutamide (Erleada) versus placebo patients with metastatic castration-sensitive prostate cancer (mCSPC).
Agarwal says the results from the HRQOL analysis showed there was no clinically relevant worsening in the favorable baseline mean of Functional Assessment of Cancer Therapy-Prostate (FACT-P) total scores and subscales, such as physical, functional, emotional, or social well-being over time in either group. The PROs demonstrated similar outcomes between the 2 groups for pain intensity and pain interference, and these remained stable over time.
In the FACT-P assessment, patients were asked how much the adverse effects of treatment bothered them. Over 86% of patients receiving apalutamide and over 85% of patients in the placebo group said they were “not at all” bothered or “a little bit” bothered. According to Agarwal, these answers are quite telling that a vast majority of the patients on the apalutamide arm are not bothered or only a little bit bothered.
Agarwal feels the stability of response over time suggests that addition of apalutamide to androgen deprivation therapy did not worsen the tolerability of treatment even after longer follow-up. Over 78% of patients given apalutamide and over 71% of patients given placebo said their energy levels were stable or improved after each cycle compared with baseline responses. This shows that apalutamide did not increase fatigue versus placebo with longer follow-up in these patients with mCSPC.