Association of statin use with overall survival and cardiac adverse events in patients with advanced prostate cancer treated with apalutamide: A pooled analysis of TITAN and SPARTAN.
Bibliographic record
Abstract
137 Background: The impact of statins on overall survival (OS) in patients (pts) with advanced prostate cancer is not fully understood. We performed a pooled analysis of the TITAN and SPARTAN trials to determine if exposure to statins had an independent effect on OS and grade ≥3 cardiac adverse events (AE) in pts treated with androgen deprivation therapy (ADT) with/without apalutamide (APA). Methods: TITAN and SPARTAN randomized pts to receive ADT with/without APA either in metastatic hormone-sensitive or in non-metastatic castration-resistant prostate cancer, respectively. Pts had at least some duration of statin exposure during the assigned treatment which could have started before and ended during or after the assigned treatment. A stratified (for the trial) multivariable Cox proportional hazard model was applied to determine the association of statin use with OS. Adjusted (adj) OS was estimated for pts in each trial, separately. A multivariable stratified logistic regression model was applied to determine the association of statin exposure with grade ≥3 cardiac AE. Results: Out of 2190 pts included in this study, 1288 received APA (TITAN 517; SPARTAN 771) and 484 were exposed to statins. Statin exposure was associated with significantly superior OS among all APA-treated pts (adjusted hazard ratio [HR]: 0.58; 95% CI: 0.45-0.75) while the OS benefit was not significant among ADT-treated pts (adjusted HR: 0.83 [0.62-1.11]). Adjusted 3-year OS in pts with and without statins were 82% and 67% (adjusted difference: 15%; 95% CI: 6-24) in the APA arm of TITAN and 86% and 78% (adjusted difference: 8% [3-13]) in the APA arm of SPARTAN. Adjusted 3-year OS among pts with and without statins was 71% and 58% (adjusted difference: 13% [3-24]) in the ADT arm of TITAN and 77% and 75% (adjusted difference: -2% [-10 to 6]) in the ADT arm of SPARTAN. Statin exposure was associated with a higher risk of grade ≥3 cardiac AE in pts treated with APA (adjusted odds ratio [OR]: 2.92 [1.56-5.47]) and ADT (adjusted OR: 3.06 [1.18-7.89]). Conclusions: In this exploratory analysis, exposure to statins was associated with significantly improved OS in all APA-treated patients but not in ADT-treated patients. Statin exposure was also associated with a higher risk of grade ≥3 cardiac AE in all pts (APA and ADT), which could be attributed to pre-existing cardiac comorbidities requiring these patients to start statin.
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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 | 0.009 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.019 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".