Bibliographic record
Abstract
Introduction & Objectives: Denosumab, an anti-RANK-ligand monoclonal antibody, has been shown to prolong bone-metastasis free survival (BMFS) by a median 4.2 months and with a 15% risk reduction vs. placebo in men with non-metastatic castrate-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) value ≥8.0 ng/mL and/or PSA doubling time (DT) ≤10.0 months.The objective of this analysis was to determine the efficacy of denosumab in men at greatest risk for bone metastases.BMFS was evaluated in a subset of men with PSADT ≤6 months (previous report in Smith MR, et al: J Clin Oncol.23:2918-2925, 2005).Methods: 1432 men with non-metastatic CRPC (baseline [median] PSA: 12.3 ng/mL, PSADT: 5.1 months, ADT duration: 47.1 months) were randomized 1:1 to receive monthly subcutaneous denosumab 120 mg or placebo.The first patient enrolled February 2006; primary analysis cut-off was July 2010, when >660 men had developed bone metastasis or died.The primary endpoint was BMFS (time to first bone metastasis or death from any cause).BMFS results are presented for men with baseline PSADT ≤6 months.Results: Median BMFS in the placebo group of men with PSADT ≤6 months was 6.5 months shorter than for the placebo group in the full population (18.7 months vs. 25.2 months), indicating that these men are at particularly high risk.In this group of men with PSADT <6 months, denosumab prolonged BMFS by a median of 7.2 months and with a 23% reduction in risk compared with placebo (Table 1).Conclusions: Patients with shortened PSADT are at higher risk of developing bone metastasis and denosumab is markedly effective at prolonging BMFS in this subset of patients.
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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 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.406 | 0.203 |
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".