Katy Beckermann, Medical Director of GU Clinical Research at Tennessee Oncology, shared a post on LinkedIn about a recent article by Alicia Morgans et al, published in Lancet Oncology:
“Patient-reported outcomes from ARANOTE catch up with the rPFS data.
Phase 3 (n=669) tested darolutamide plus ADT vs placebo plus ADT in mHSPC. The PRO secondary analyses were just published in Lancet Oncology.
Time to pain progression: HR 0.72 (95% CI 0.54-0.96)
Time to FACT-P deterioration: HR 0.76 (0.61-0.94)
Grade 3-4 AEs match placebo (HTN 4% vs 4%; anemia 3% vs 4%)
Serious AEs identical at 24%
Practice implication: darolutamide plus ADT now has PRO data aligning with its rPFS HR 0.54. For mHSPC patients prioritizing tolerability, this strengthens the case in shared decision-making.
Caveat: no head-to-head ARSI PRO comparisons.”
Title: Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial
Authors: Alicia Morgans, Kunhi Haresh, Mindaugas Jievaltas, David Olmos, Neal Shore, Egils Vjaters, Nianzeng Xing, Ateesha Mohamed, Natasha Littleton, Shankar Srinivasan, Frank Verholen, Fred Saad
Read the Full Article on The Lancet Oncology
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