(UroToday.com) The 2023 American Society of Clinical Oncology (ASCO) annual meeting included a prostate cancer session, featuring a presentation by Dr. Matthew Smith discussing darolutamide and time to pain progression by disease volume in the ARASENS trial. In ARASENS (NCT02799602), darolutamide + ADT + docetaxel significantly reduced the risk of death by 32.5% (HR 0.68, 95% CI 0.57–0.80) and significantly delayed time to pain progression (HR 0.79, 95% CI 0.66–0.95) vs placebo + ADT + docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).1 At the ASCO 2023 annual meeting, Dr. Smith and colleagues reported time to pain progression in patients with high/low disease volume.
Patients with mHSPC were randomized to oral darolutamide 600 mg twice daily or placebo, both + ADT + docetaxel. Pain was assessed by the Brief Pain Inventory short form “pain at its worst” score (WPS). Pain progression was defined as WPS increase ≥2 points from nadir (and absolute WPS ≥4 if > 0 at baseline) or initiation of opioid therapy for ≥7 consecutive days. Additionally, a sensitivity analysis assessed pain progression after the completion of docetaxel. High/low disease volume subgroups were defined per CHAARTED.
In this analysis, there were 1,305 patients (darolutamide 651, placebo 654) analyzed. At baseline, the mean WPS was 1.5 (SD 1.9) vs 1.4 (SD 1.8) in the darolutamide vs placebo groups; 258 (40%) vs 274 (42%) patients had no pain (WPS 0). Darolutamide + ADT + docetaxel had a robust impact on delaying time to pain progression vs placebo + ADT + docetaxel in the post-docetaxel sensitivity analysis (stratified HR 0.75, 95% CI 0.62–0.90) and in the high volume subgroup (unstratified HR 0.75, 95% CI 0.61–0.93):
Overall, the median time to pain progression was longer in the low-volume vs high volume subgroup. WPS change from nadir was the main driver of pain progression events.
Dr. Smith concluded his presentation discussing darolutamide and time to pain progression by disease volume in ARASENS with the following take-home points:
- In patients with mHSPC, the addition of darolutamide to ADT and docetaxel provided clinically meaningful benefit through delayed time to pain progression, notably in patients with high volume disease
- Increased overall survival, a delay in time to pain progression, and a favorable safety profile set darolutamide + ADT + docetaxel as a new standard of care for patients with mHSPC
Presented by: Matthew R. Smith, MD, Ph.D., Claire and John Bertucci Endowed Chair in Genitourinary Cancers, Professor of Medicine, Harvard Medical School
Director, Genitourinary Malignancies Program, Massachusetts General Hospital, Boston, MA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.
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