Radium-223 (Ra-223) in asymptomatic metastatic castration-resistant prostate cancer (mCRPC) patients treated in an international early access program (iEAP).
Bibliographic record
Abstract
158 Background: Ra-223, a targeted alpha therapy, is currently used to treat mCRPC patients (pts). To investigate Ra-223 when used early in the disease course, we analyzed safety and efficacy in mCRPC pts with no symptoms at baseline treated in an iEAP. Methods: This was a prospective, single-arm phase 3b study of mCRPC pts (malignant lymphadenopathy not exceeding 6 cm was allowed, visceral disease was excluded). Pts received Ra-223, 55 kBq/kg IV, every 4 weeks for up to 6 cycles. Co-primary endpoints were safety and overall survival (OS). Post hoc analyses were performed according to asymptomatic or symptomatic disease status at baseline. Asymptomatic was defined as no pain and no opioid use at baseline. Results: 708 pts received ≥1 Ra-223 injection: 548 (77%) were defined as symptomatic and 135 (19%) were defined as asymptomatic. Asymptomatic pts had more favorable baseline characteristics than symptomatic pts (table). Fewer asymptomatic pts had received prior abiraterone (34 pts, 25% vs 190, 35%), enzalutamide (5 pts, 4% vs 43, 8%) and prior docetaxel (70 pts, 52% vs 339, 62%). More asymptomatic pts received 6 cycles of Ra-223 (96, 71% vs 300, 55%). Adverse events (AEs) were reported for fewer pts with asymptomatic vs symptomatic disease: any grade, 61% vs 79%; grade 3/4, 29% vs 40% and serious AEs, 22% vs 38%. OS was longer in asymptomatic pts and ALP normalization was more common (table). Conclusions: Asymptomatic pts were more likely to have a better prognosis and to complete all 6 cycles of Ra-223. Ongoing first-line combination studies (ERA-223: NCT02043678 and PEACE-3: NCT02194842) may show whether Ra-223 administered early in the disease course will lead to better outcomes. Clinical trial information: NCT01618370. [Table: see text]
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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".