Effect of zoledronic acid (Z) on pain in prostate cancer patients with bone metastases based on performance status
Bibliographic record
Abstract
14544 Background: Z has demonstrated efficacy in reducing, preventing, delaying the occurrence of an SRE (Skeletal Related Event) including pathologic fractures, severe bone pain requiring radiation therapy, spinal cord compression, surgery to bone and hypercalcemia of malignancy which could lead to a loss of independence. Effects of Z on pain were analyzed in a subgroup of patients based on performance status. Methods: Subjects were randomised to Z 4mg (n = 201) or placebo (n = 201). The short form of the Brief Pain Inventory (BPI) was administered at baseline (visit 2), and visits 3 (weeks 3–4), 4 (weeks 6–8), and then every second visit (every 6 weeks) until study end. Changes in BPI individual item scores and the Pain severity and Pain Interference scale scores were compared between Z and placebo groups. Post baseline missing data were replaced by Last Observation carried forward (LOCF). Changes in scores were examined in the subgroup of patients with ECOG performance status scores of ≥ 1. Results: For patients ECOG score of ≥ 1 at baseline (n = 227), Z was superior to placebo in the BPI items ‘pain at its worst’, ‘pain at its least’, ‘pain on average’, and the Pain Severity scale at visit 4 (weeks 6–8) and visit 6 (week 12) (p < 0.05). At visit 8 (weeks 18–20) Z was superior to placebo on the ‘pain on average’ item and Pain Severity scale (p < 0.05). For visit 12 (weeks 30–32) and for LOCF Z was superior to placebo for ‘pain at its worst’, ‘pain on average’ and Pain Severity (p < 0.05 for all). For the ‘pain right now’ item there were statistically significant differences at visits 4, 6, 12 and LOCF (p < 0.05). In addition, at visit 6 (week 12), Z was superior to placebo for changes in items assessing interference with: sleep, general activities, mood, walking and enjoyment of life (p < 0.05). Z was also superior to placebo for ‘interference with general activities’ at visits 12 (weeks 30–32), 16 (weeks 42–44) and LOCF (p < 0.05). Conclusion: Results suggest Z provides significant benefit in pain reduction and Z may have an impact on patients’ daily activities which may lead to a preservation of patients’ functionality. [Table: see text]
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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 | 0.000 | 0.001 |
| 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".