medwireNews: Men with metastatic castration-sensitive prostate cancer (mCSPC) continue to derive a survival benefit from the addition of apalutamide to androgen deprivation therapy (ADT), suggest long-term data from the TITAN trial.
At a median follow-up of 44 months, the risk for death was a significant 35% lower for the 525 participants who were randomly assigned to receive apalutamide 240 mg/day alongside ADT than for their 527 counterparts who instead received placebo plus ADT. The median overall survival (OS) durations were unreached and 52.2 months, respectively.
“The survival benefit of apalutamide was observed despite almost 40% of placebo-treated patients without progression crossing over to apalutamide after study unblinding,” note Kim Chi (BC Cancer and Vancouver Prostate Centre, British Columbia, Canada) and co-investigators in the Journal of Clinical Oncology.
And indeed, the risk for death was reduced by a significant 48% with apalutamide versus placebo after adjusting for crossover.
The addition of apalutamide also delayed second progression-free survival and castration resistance, report the researchers, adding that: “With substantially longer follow-up and exposure than at the primary analysis, apalutamide treatment had a safety profile consistent with previous reports and patients maintained health-related quality of life under treatment with apalutamide.”
And the team concludes: “These results support the early addition of apalutamide to ADT for optimal therapeutic outcomes in patients with mCSPC.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group