Degarelix monotherapy versus luteinizing hormone-releasing hormone (LHRH) agonists plus antiandrogen flare protection in the treatment of men with advanced prostate cancer.
Bibliographic record
Abstract
86 Background: Short-term antiandrogen (AA) flare protection is used to counter the testosterone surge associated with luteinising-hormone-releasing hormone (LHRH) agonist therapy. Degarelix, a gonadotrophin-releasing hormone antagonist, does not cause testosterone surge. Data from two phase III trials have been used to compare the one year efficacy of degarelix monotherapy versus combined agonist plus AA flare protection. Data has reported testosterone surge in agonist patients despite AA therapy, as well as improved prostate-specific antigen (PSA) progression-free survival (PFS) and lower mortality in degarelix patients. Here we focus on PSA PFS outcomes and serum alkaline phosphatase (S-ALP) in high risk patients (metastatic disease or PSA more than 50 ng/mL). Methods: Data were pooled from two randomised, one-year studies; CS21 compared monthly degarelix with leuprolide and CS35 compared 3 month formulations of degarelix and goserelin. AA was administered in the agonist groups at the investigator’s discretion. Analyses were performed by the Kaplan-Meier method and Log-rank test (probability of PSA PFS), Cox regression (adjusted hazard ratios [HR] for PSA PFS failure) and repeated measures ANCOVA (S-ALP). Results: Nine hundred seventy four patients received degarelix and 69 patients agonist plus AA. The agonist plus AA group contained a higher proportion of patients with Gleason score 7 to 10, metastatic disease, or baseline PSA more than 50 ng/mL compared with the degarelix group. Cox regression was used to account for these baseline differences. PSA PFS failure rate for metastatic patients and those with baseline PSA more than 50 ng/mL was significantly lower with degarelix than with agonist plus AA (HR=0.516, p=0.0198 and HR=0.490, p=0.0077, respectively). S-ALP levels in metastatic patients and those with baseline PSA more than 50 ng/mL during the year of treatment were significantly lower with degarelix (p=0.0025 and 0.0005, respectively). S-ALP fell below baseline by 2 months or less with degarelix and 7 months or less with agonist plus AA. Conclusions: This pooled analysis indicates LHRH agonist plus AA therapy flare protection may not achieve similar disease control as degarelix monotherapy during the first year of therapy in patients at high risk of symptomatic disease progression.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".