Meta-analysis of the impact of single agent daily prednisone on outcomes and toxicities in metastatic castration-resistant prostate cancer (mCRPC).
Bibliographic record
Abstract
e16095 Background: Oral prednisone (P) has been commonly employed for the therapy of men with mCRPC. However, its clinical impact is unknown. We performed a pooled analysis of control arms of randomized trials which either did or did not administer single agent P. Methods: Randomized trials with a control arm including single agent placebo (or no anti-cancer therapy) or single-agent P (+/- placebo) were eligible for analysis. Patients receiving P in combination with other agents in the control arm were excluded. Trial characteristics and baseline demographics were collected from published manuscripts along with reported outcomes including overall survival (OS), progression free survival (PFS), prostate-specific antigen (PSA) response, RECIST response, and toxicities (i.e. all grades and grade ≥ 3). P specific toxicities were also collected including hyperglycemia, hypertension, hypokalemia, skeletal related events and edema. Impact of P was investigated for significance in bivariate models, adjusting for age, pre/post-docetaxel status, ECOG performance status (PS) and trial publication year. Trials were weighted based on sample size. Results: Eighteen trials were included in the analysis, within which nine had control arms that contained P (N = 2831) and nine did not (N = 2784). Age, pre/post-docetaxel status, PS and publication year were similar in both groups. No significant differences were identified for OS or toxicities of any grade. A significantly higher PSA response rate (18.8% vs. 2.5%, P= 0.023) and a trend for more frequent grade ≥ 3 fluid retention (1.0% vs. 0.4%, P= 0.097) was seen in the P group. In most bivariate analyses, P was significantly associated with PSA response. P was also significantly associated with PFS after adjusting for docetaxel status. Conclusions: Single agent P for mCRPC was not associated with extension of OS, but was associated with a higher PSA response rate and a potential extension in PFS. Overall and grade ≥ 3 toxicities were not significantly higher with P, although a trend for increased fluid retention was seen. With the exception of concurrent use with abiraterone or for palliative purposes, the routine use of P appears unnecessary.
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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 | 0.022 | 0.035 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.014 | 0.049 |
| Bibliometrics | 0.005 | 0.006 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".