Bibliographic record
Abstract
Introduction and Objective: Abiraterone acetate (AA) is an androgen biosynthesis inhibitor that selectively inhibits CYP17, blocking testicular, adrenal, and prostatic intratumoral androgen synthesis.Studies suggest that some metastatic castration-resistant prostate cancers (mCRPCs) remain dependent on androgen receptor (AR) signaling.Methods: In COU-AA-301 patients (pts) with docetaxel-treated mCRPC were randomized 2:1 to AA (1000 mg) + prednisone (P) (5 mg BID) (n=797) or placebo + P (n=398) at 147 centers in 13 countries.The primary endpoint was overall survival (OS).PSA and radiographic assessments were adapted from PSAWG criteria (Bubley, JCO, 1999).Safety assessments were standard.Results: Based on a pre-specified interim analysis, the IDMC recommended the study be unblinded.Efficacy results from 1195 enrolled patients are presented (Table 1).Grade 3/4 AEs occurred in 55% of pts with AA vs 58% with placebo.Frequently occurring (>5%) adverse events (AEs) with AA vs placebo were: fatigue (8% vs 10%), anemia (7.5% vs 7.4%), back pain (6% vs 10%), and spinal cord compression (3% vs 5%).The most common grade 3/4 laboratory-related AEs were decreased lymphocytes (21% vs 23%) and increased ALP (18% vs 13%).Grade 3/4 AEs of special interest (AA vs placebo) were: fluid retention (2.3% vs 1%), hypokalemia (3.8% vs 0.8%), LFT abnormalities (3.5% vs 3.0%), hypertension (1.3% vs 0.3%), and cardiac disorders (4.1% vs 2.3%).The cardiac disorders were predominantly arrhythmias; there was no imbalance in cardiac AEs with an outcome of death (1.1% vs 1.3% with AA vs placebo).Conclusions: AA + P has a favorable safety profile and significantly improves OS, TTPP, rPFS, PSA response rate, and radiologic response rate in patients with mCRPC post docetaxel.This Phase III study confirms that AA provides clinical benefit following medical/surgical castration in postdocetaxel mCRPC.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.000 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.766 | 0.523 |
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".