Effect of zoledronic acid on bone pain and skeletal morbidity in patients with advanced prostate cancer; analysis by baseline pain
Bibliographic record
Abstract
4561 Background: Zoledronic acid (Zol) is the only bisphosphonate to significantly reduce skeletal-related events (SREs) and pain compared with placebo in patients (pts) with advanced prostate cancer and bone metastases. To further assess the benefit of Zol, this exploratory retrospective analysis evaluated the effect of Zol on the incidence of SREs based on baseline pain levels and pain. Methods: Zol 4 mg or placebo was administered to pts (N = 422) with prostate cancer every 3 weeks for up to 24 months. Bone pain was assessed using the Brief Pain Inventory (BPI) at 6-week intervals. Changes in BPI composite pain score (defined as the average of “worst pain,” “least pain,” and “average pain” over the last 7 days and “pain right now”) were analyzed based on presence of pain at baseline. For missing data, the last observation was carried forward. Results: Of 371 evaluable pts, 270 (73%) reported pain at baseline, with a mean baseline composite BPI score of ∼2.8 (range, 0 to 10) in both treatment groups. Among these pts, decreases from mean baseline pain scores of -10%, -4%, and -1% at months 3, 6, and 9, respectively, were reported in pts who received Zol compared with increases of 6%, 9%, and 13% from baseline in the placebo group (P = .021 at Month 3). During months 12 through 24, both groups had increased pain scores; however, Zol-treated pts had smaller increases (range, 1% to 6%) compared with placebo (range, 15% to 25%) and the between-group differences were statistically significant at Month 21 (P = .024) and Month 24 (P = .034). Further, Zol decreased the proportion of pts who developed an SRE by 9% and the mean annual incidence of SREs by 39% compared with placebo. Among 101 (27%) pts with no pain at baseline, mean pain scores increased in both treatment groups. Zol decreased the proportion of pts developing an SRE by 19% and the mean annual incidence of SREs by 49% compared with placebo. Conclusions: Zol provides reduction of SREs and pain in pts with bone metastases from prostate cancer regardless of the presence of baseline pain, suggesting that early and continued Zol treatment may improve quality of life in these pts. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis (employee) Novartis Novartis Novartis, Novartis Oncology Novartis
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".