Comparative real-world (RW) evidence on darolutamide (Daro), enzalutamide (Enza), and apalutamide (Apa) for patients (Pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) in the United States: DEAR.
Bibliographic record
Abstract
5097 Background: Novel androgen receptor inhibitors (ARIs) are recommended for pts with nmCRPC. Daro has a distinct structure with low blood-brain barrier penetration which may lead to a lower risk of central nervous system-related adverse events (AEs) and minimal risk of AEs commonly associated with ARIs. DEAR is the first study comparing RW utilization, outcomes, and AEs between daro and enza/apa in nmCRPC pts. Methods: This retrospective chart review cohort study uses electronic medical records from the PPS network of US urology practices. Eligible pts had nmCRPC, no prior novel hormonal therapy, and initiated first ARI treatment (index date) between 8/2019-3/2022. We describe the % of pts who discontinued initial ARI treatment (DISC), % who progressed to metastasis (PROG), and % with AEs. A comparative analysis was performed between daro and enza/apa using Cox proportional hazards models for time to DISC/time to PROG, adjusting for observed baseline (BL) factors. Results: 870 pts were included (daro/enza/apa, n=362/382/126). Median age (80/79/80 y), median BL prostate-specific antigen (PSA) doubling time (6.8/6.4/7.4 mo), other BL characteristics, and median follow-up (22.2/22.7/23.3 mo) were similar for daro/enza/apa. A lower % of pts had a DISC event on daro vs enza/apa (30.4 vs 40.8/46.0) or a PROG event (17.7 vs 28.3/27.8) during the study period. Multivariate analyses adjusting for BL factors showed that pts on daro had a lower risk of DISC and PROG over time vs enza/apa. A lower % of pts on daro had AEs vs enza/apa (24.9 vs 29.3/30.2). Conclusions: Overall, a lower % of pts discontinued initial ARI treatment, progressed to metastasis, or had AEs on daro vs enza/apa. In analyses adjusting for observed BL factors, pts on daro had considerably lower risk of DISC and PROG vs enza/apa. This study confirms daro’s strong efficacy and favorable tolerability profile in a RW setting. The longer treatment duration seen with daro may be associated with a lower risk of progression to mCRPC vs enza/apa. [Table: see text]
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.014 | 0.038 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
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".