Clinical benefit of zoledronic acid in patients with lung cancer and other solid tumors: Analysis based on prior history of skeletal complications
Bibliographic record
Abstract
7226 Background: We previously reported the efficacy and safety of 4 mg zoledronic acid in patients with bone metastases secondary to lung cancer or other solid tumors (Rosen et al. J Clin Oncol. 2003;21:3150–3157). We report here the results of a retrospective exploratory analysis to assess the risk of skeletal-related events (SREs) and the efficacy of 4 mg zoledronic acid compared with placebo based on patients' history of SREs prior to study entry. Methods: An SRE was defined as a pathologic fracture, spinal cord compression, radiotherapy or surgery to bone, or hypercalcemia. Patients were stratified based on their history of SREs before study entry, and the occurrence of SREs on study (over 21 months) was analyzed. Results: A total of 507 patients were randomized to 4 mg zoledronic acid or placebo; 131 completed the 9-month core phase, and 69 entered the 12-month extension phase. Before study entry, 347 (68%) of patients experienced at least 1 SRE, and these patients were at higher risk of developing an SRE on study than patients with no prior SRE (hazard ratio = 1.43). In the placebo group, 52% of patients with a prior SRE had at least 1 SRE on study compared with only 40% of patients with no prior SRE. Among patients with an SRE before study entry, Andersen-Gill multiple event analysis showed that zoledronic acid significantly reduced the risk of developing an SRE on study by 31% compared with placebo (risk ratio = 0.688; P = .009). Zoledronic acid also significantly reduced the mean skeletal morbidity rate (1.96 versus 2.81 SREs/year for placebo; P = .030) and prolonged median time to first on-study SRE by nearly 4 months (215 versus 106 days for placebo; P = .011). Among patients with no SRE before study entry (n = 156), zoledronic acid reduced the risk of SREs by 23% (P = .308), reduced the mean skeletal morbidity rate (1.34 versus 2.53 SREs/year for placebo; P = .332), and prolonged the median time to first SRE by 2.5 months (P = .534). Conclusions: This exploratory analysis demonstrates that patients with a history of SREs are at high risk of subsequent SREs, and zoledronic acid reduces skeletal morbidity regardless of a prior history of SREs. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Pharmaceuticals Corp. 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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".