ESMO 2019: Patient-Reported Outcomes From TITAN: A Phase 3, Randomized, Double-Blind Study of Apalutamide Versus Placebo Added to Androgen Deprivation Therapy in Patients With Metastatic Castration-Sensitive Prostate Cancer

Barcelona, Spain (UroToday.com) The randomized, phase 3 TITAN study evaluated the addition of apalutamide versus placebo to androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Results from TITAN demonstrated that apalutamide plus ADT significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo plus ADT in men with mHSPC.1 This abstract presents patient-reported outcomes from the TITAN study.

Patient-reported outcomes were assessed in the TITAN study using the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and Euro QoL Group EQ-5D-5L. BPI and BFI were completed for 7 consecutive days (Day 6 plus Day 1 of each Cycle visit), then at months 4, 8, and 12 in follow-up. FACT-P and EQ-5D-5L were completed Cycle 1 through Cycle 7 and then every other Cycle through end of treatment, as well as at months 4, 8, and 12 in follow-up. Analyses included descriptive statistics and mean change from baseline using mixed model of repeated measures.

All pain metrics assessed supported that the addition of apalutamide slowed pain progression, reduced pain intensity and interference, and decreased the average amount of pain. Patients with severe pain at baseline had the most improvement with the addition of apalutamide.

ESMO 2019 TITAN study time to pain progression

ESMO 2019 TITAN study baseline pain

The addition of apalutamide to ADT did not increase fatigue intensity or interference. Based on FACT-P total scores, health-related quality of life was preserved. Further, the number of patients who responded “I am bothered by side effects of treatment” was similar among patients treated with apalutamide + ADT versus placebo + ADT.

ESMO 2019 TITAN study side effects

In conclusion, the investigators found that in addition to the substantial benefits in the dual TITAN primary endpoints of OS and rPFS, overall health-related quality of life was preserved with the addition of apalutamide to ADT in patients with mHSPC. These effects were observed for patients with high-volume or low-volume disease, previous docetaxel use, previous treatment for localized disease, and previously or newly diagnosed disease.

Presented by: Neeraj Agarwal, MD, Associate Professor, Division of Oncology, University of Utah School of Medicine, Director of the Genitourinary Oncology Program in the Oncology Division, Co-leader of the Urologic Oncology Multidisciplinary Program and Associate Director of Clinical Trials (solid tumors) at the Huntsman Cancer Institute (HCI), Salt Lake City, Utah, USA 

Written by: Jacob Berchuck, MD, Medical Oncology Fellow at the Dana-Farber Cancer Institute, Twitter: @jberchuck, at the 2019 European Society for Medical Oncology Congress (#ESMO19), September 27th to October 1st, 2019, Barcelona, Spain

References:
  1. Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24.
Further Related Content:

Read: 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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