Validation of the association of RECIST 1.0 changes with survival in men with metastatic castration-resistant prostate cancer (mCRPC) treated on SWOG Study S0421.
Bibliographic record
Abstract
5079 Background: Prostate specific antigen (PSA) and bone scan changes are often used as components of primary endpoints in phase II trials of mCRPC. However, they do not reliably capture drug activity, as suggested by multiple phase III trials that failed to validate promising activity in phase II trials. Recently, an association between RECIST 1.0 changes and overall survival (OS) in men with mCRPC receiving docetaxel was observed. We externally validated the prognostic impact of RECIST 1.0 changes on OS. Methods: S0421 was a phase III trial in men with mCRPC men treated with docetaxel and prednisone plus either placebo or atrasentan. Individual patient data from both arms of were combined for analysis since no differences in outcomes were observed. Cox proportional hazards regression evaluated the association of RECIST outcomes within 120 days, i.e. unconfirmed partial response (PR), stable disease (SD) and progressive disease (PD) with OS from day 120. The analysis was adjusted for selected major baseline prognostic factors: hemoglobin, alkaline phosphatase, PSA, treatment arm, performance status, visceral disease, progression type, pain and Gleason score. All tests were two-sided and P ≤ 0.05 was considered statistically significant. Results: Of 1038 eligible patients on S0421, 469 had measurable disease. Of these, 377 had RECIST assessments within 120 days after starting therapy. From day 120, 23 patients had PD, 230 had SD, and 73 had ≥ PR (n = 73). Median OS of was 7.1, 13.4 and 16.3 months, respectively (p = 0.004). After adjusting for baseline factors, RECIST changes remained significantly associated with OS (p = 0.002). For every 10% increase in lesion size, the hazard of dying after day 120 increased by 6.3% (95% CI: 2.3% to 10.5%, p = 0.0018), after adjusting for prognostic factors. Conclusions: This analysis provides external validation of the association of RECIST 1.0 changes with OS in men with mCRPC receiving docetaxel-based chemotherapy. Given that current imaging is increasingly detecting measurable disease, a robust and objective signal of activity represented by RECIST changes should be shown in phase II trials before launching phase III trials.
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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 | 0.007 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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".