Enzalutamide with or without leuprolide in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis by age
Bibliographic record
Abstract
INTRODUCTION: The EMBARK trial demonstrated that enzalutamide ± leuprolide significantly improved metastasis-free survival (MFS) in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence (hrBCR). This post hoc analysis reports the efficacy and safety results when patients were stratified by age. METHODS: The EMBARK trial (NCT02319837) included patients with hrBCR after local therapy, prostate-specific antigen (PSA) doubling time ≤ 9 months, and PSA ≥ 2 ng/mL above nadir post radiotherapy (RT) or ≥ 1 ng/mL after radical prostatectomy ± postoperative RT. Patients were randomized (1:1:1) to enzalutamide with leuprolide (combination), leuprolide and placebo (leuprolide alone), or enzalutamide alone (monotherapy). This analysis compares MFS and safety outcomes by age group (<70 vs ≥70 years). RESULTS: Of 1068 patients, 543 (51 %) were aged < 70 years and 525 (49 %) were aged ≥ 70 years. Patients ≥ 70 years had higher median baseline PSA and higher rates of primary RT versus patients < 70 years across all treatment groups. Improvements in MFS were observed in the combination and monotherapy groups compared with leuprolide alone, regardless of age. Treatment-related serious adverse events (TRSAEs) and grade ≥ 3 AEs were more common in patients aged ≥ 70 years versus < 70 years for all treatment groups, but TRSAEs were low in all treatment and age groups (TRSAEs: 0.6-11.7 %; grade ≥3 AEs: 36.3-60.1 %). CONCLUSION: Clinically meaningful improvements in MFS were observed following enzalutamide ± leuprolide in patients with hrBCR regardless of age. TRSAEs were more common in older patients but were low regardless of age. These findings should be interpreted in light of small subgroup sizes.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".