Change in bone alkaline phosphatase as an outcome predictor in men with hormone-refractory prostate cancer metastasized to bone
Bibliographic record
Abstract
4655 Background: Bone alkaline phosphatase (BAP) has been validated as a potential predictor of survival in hormone-refractory prostate cancer (HRPC) patients. Phase 2 results show that atrasentan, a potent, selective, oral endothelin A receptor antagonist, significantly attenuates BAP increase in men with metastatic HRPC. We tested the hypothesis that BAP change predicts time to disease progression (TTP) and survival in men with HRPC metastasized to bone. Methods: Data from 684* HRPC patients with bony metastases included in a phase 3, randomized, double-blind, placebo-controlled trial of atrasentan were stratified by the treatment-pooled median change in BAP from baseline at weeks 4, 8, and 12. Kaplan-Meier and Cox proportional hazard methodologies were used to compare TTP (a composite of radiographic and clinical measures) and survival in each group at each time point. Atrasentan treatment effect was analyzed using analysis of covariance comparing changes in BAP from baseline between treatment arms. Results: TTP was significantly delayed in patients whose change from baseline in BAP was lower than the pooled median change at that time point versus those whose change was higher than the median (table). Survival was also prolonged in patients with a BAP change from baseline below the median versus those above the median (week 4: HR = 1.29, 95% CI = 0.99–1.67, p=0.057; week 8: HR = 1.77, 95% CI = 1.34–2.34, p<0.001; week 12: HR = 1.77, 95% CI = 1.31–2.40, p<0.001). Atrasentan resulted in a significantly lower mean change in BAP from baseline at weeks 4, 8, and 12 versus placebo (p<0.001, p=0.006, p=0.001). Conclusion: These data support the hypothesis that change in BAP is predictive of TTP and survival in HRPC patients with bony metastases. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories Abbott Laboratories Abbott Laboratories
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| 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) | 0.001 | 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".