Abstract B131: Efficacy and safety of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel in Black/African-American patients from the phase 3 ARASENS trial
Bibliographic record
Abstract
Abstract Introduction: Blacks/African-Americans (B/AAs) are disproportionately affected by prostate cancer, with higher incidence and mortality rates versus other racial/ethnic groups. Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the ARASENS trial (NCT02799602), DARO in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI 0.57–0.80; P<0.001) vs placebo (PBO) + ADT with docetaxel in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of DARO + ADT and docetaxel in B/AAs from ARASENS. Methods: Pts with mHSPC were randomized 1:1 to DARO 600 mg or PBO twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival (OS). Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety. Results: In ARASENS, 54 B/AAs received DARO (n=26) or PBO (n=28); 36/244 (14.8%) patients recruited in North America were B/AA. Baseline characteristics in the B/AA population were generally similar compared with the overall population, except for the proportion of pts who were <65 years of age (57.4% vs 36.6%), had ECOG performance status of 1 (37.0% vs 28.7%) and recurrent disease (24.1% vs 12.9%). Median prostate-specific antigen levels were similar (35.9 vs 27.6 μg/L), but alkaline phosphatase levels were lower in B/AAs (109.5 vs 143.0 U/L) vs all patients. In B/AAs, OS favored DARO + ADT + docetaxel vs PBO + ADT + docetaxel (stratified HR, 0.41; 95% CI, 0.17–1.02), with 4-year survival rates of 62% vs 41%. The DARO group also had longer time to CRPC vs PBO (median, not reached vs 12.6 months; HR, 0.09; 95% CI 0.02–0.30). The safety profile of DARO in B/AAs was consistent with that observed for all patients (grade 3/4 adverse events [AEs]: 57.7% vs 66.1%; serious AEs: 42.3% vs 44.8%). The occurrence of discontinuations of DARO/PBO due to AEs and AEs associated with androgen receptor pathway inhibitors (eg, fatigue/asthenia, vasodilation/flushing, hypertension, diabetes/hyperglycemia, cardiac disorders, fall, depressed mood disorders, rash, fracture, decreased weight, mental impairment, and breast disorders/gynecomastia) were similar between treatment groups in B/AAs and consistent with the overall population. Conclusions: In this small population of B/AAs with mHSPC from the ARASENS trial, DARO was associated with an improvement in OS and time to CRPC and was well tolerated. Efficacy and safety findings in B/AAs were consistent with the overall ARASENS population. Citation Format: Neal D. Shore, Maha H.A. Hussain, Fred Saad, Karim Fizazi, Cora N. Sternberg, E. David Crawford, Bertrand Tombal, Luke Nordquist, Michael Cookson, Jay Jhaveri, Silke Thiele, Shankar Srinivasan, Jorge Ortiz, Matthew R. Smith. Efficacy and safety of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel in Black/African-American patients from the phase 3 ARASENS trial [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B131.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".