Secondary outcomes by prior definitive treatment (tx) in patients (pts) with high-risk biochemically recurrent prostate cancer (hrBCR) treated with enzalutamide (enza) plus leuprolide (combo): EMBARK post hoc analysis.
Bibliographic record
Abstract
159 Background: In the phase 3 EMBARK trial, combo vs leuprolide alone meaningfully improved metastasis-free survival (primary endpoint) and secondary efficacy endpoints. Secondary endpoints for combo vs leuprolide alone are reported across prior definitive tx subgroups. Methods: EMBARK enrolled pts with hrBCR, defined as a PSA doubling time ≤9 months and PSA ≥1 ng/mL post radical prostatectomy (RP) ± radiotherapy (RT) or ≥2 ng/mL above nadir post RT. Pts were randomized 1:1:1 to combo, leuprolide alone, or enza monotherapy. Secondary endpoints included time to PSA progression, first use of new antineoplastic tx, distant metastasis, resumption of any hormonal therapy after tx suspension, and symptomatic progression. Post hoc subgroup analyses descriptively compared secondary endpoints for combo vs leuprolide alone in pts with prior RP only, RT only, or RP+RT. Results: Half of pts in each tx group (combo and leuprolide alone) had prior RP+RT (Table). All secondary endpoints favored combo vs leuprolide alone in all prior definitive tx subgroups (Table). When testing for interactions, there were no statistically significant differences in the observed tx effects for the key secondary endpoints of time to PSA progression ( P interaction =0.79) and first use of new antineoplastic tx ( P interaction =0.57) across prior definitive tx subgroups. P-interactions for other endpoints will be reported in the presentation. Conclusions: Tx with combo showed improvements in all secondary endpoints vs leuprolide alone in all prior definitive tx subgroups, which supports the benefits of combo as the new standard of care for pts with hrBCR regardless of prior definitive tx. The small sample sizes of the non-randomized subgroups and low event numbers should be considered when interpreting results. There were no interactions by prior tx for two key secondary endpoints. Pfizer's generative AI tool, MAIA, was used to draft this abstract (accessed: 2024-10-01); the authors reviewed, edited, and take full responsibility for the content. Clinical trial information: NCT02319837 . Secondary endpoints Combo(n=355) Leuprolide alone(n=358) † RP only(n=90) RT only (n=86) RP+RT (n=179) RP only (n=75) RT only (n=104) RP+RT (n=179) Time to: Events, n HR (95% CI) Events, n HR (95% CI) Events, n HR (95% CI) Events, n Events, n Events, n PSA progression 1 0.05(0.01, 0.41) 4 0.10(0.03, 0.27) 3 0.06(0.02, 0.21) 17 37 39 First use of new antineoplastic tx 16 0.54(0.28, 1.02) 15 0.28(0.15, 0.52) 27 0.34(0.21, 0.53) 25 48 67 Distant metastasis 5 0.51(0.17, 1.59) 12 0.47(0.22, 1.00) 13 0.34(0.18, 0.67) 9 20 30 Resumption of any hormonal therapy 69 0.74(0.51, 1.08) 64 0.92(0.61, 1.39) 123 0.60(0.46, 0.79) 54 47 116 Symptomatic progression 29 0.76(0.46, 1.28) 27 0.55(0.34, 0.89) 48 0.46(0.32, 0.66)
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".