Bibliographic record
Abstract
Introduction and Objectives: MDV3100, a novel ARSI, competitively inhibits binding of androgens to the androgen receptor (AR), inhibits AR nuclear translocation, and inhibits AR-DNA binding.MDV3100 was developed based on activity in prostate cancer cell model systems with overexpressed AR and was active in a Phase 1-2 trial of prostate cancer patients with progressive castration resistant disease (CRPC).The AFFIRM trial evaluated if MDV3100 could prolong overall survival in CRPC patients post docetaxel.Methods: In this randomized, double-blind, placebo-controlled, multinational Phase 3 study (NCT00974311), patients who had ≤2 docetaxelbased regimens were randomized 2:1 to MDV3100 160 mg/d or placebo.Corticosteroids were allowed but not required.Patients were stratified by baseline ECOG performance status and mean brief pain inventory score.The primary endpoint was overall survival (OS).Secondary efficacy endpoints included radiographic progression-free survival, time to first skeletalrelated event, and time to PSA progression.Results: 1,199 patients were randomized between Sept 2009 and Nov 2010.Based on a planned interim analysis at 520 death events, the Independent Data Monitoring Committee recommended halting the study and placebo patients offered MDV3100 due to a significant OS benefit.Patients on MDV3100 had a median OS of 18.4 months, an increase of 4.8 months compared to placebo (13.6 months), p<0.0001, hazard ratio 0.631.Results for the secondary endpoints and safety will also be presented.Conclusions: MDV3100 significantly improved OS in men with postdocetaxel CRPC reducing the risk of death by 37% compared to placebo.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.657 | 0.486 |
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".