Tolerability of [<sup>177</sup>Lu]Lu-PSMA-617 by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): A VISION study subgroup analysis.
Bibliographic record
Abstract
5047 Background: In the phase 3 VISION study, lutetium (177Lu) vipivotide tetraxetan ([177Lu]Lu-PSMA-617; 177Lu-PSMA-617) + protocol-permitted standard of care (SoC) improved clinical benefit and was generally well tolerated despite a higher rate of adverse events (AEs) than SoC alone. Here we assess AE incidence by exposure to 177Lu-PSMA-617. Methods: VISION was an international, open-label study of 177Lu-PSMA-617 in adults with PSMA-positive mCRPC previously treated with ≥ 1 androgen receptor pathway inhibitor and 1–2 taxane regimens. Patients received 177Lu-PSMA-617 (7.4 GBq every 6 weeks, ≤ 6 cycles) + SoC or SoC alone. rPFS and OS were primary endpoints; safety was a secondary endpoint. AE analysis by exposure to 177Lu-PSMA-617 was carried out in pre-specified subgroups. 177Lu-PSMA-617 cycle duration was generally ̃6 weeks and cycle 6 duration was until the earliest date of subsequent treatment, and date of last administration of randomized treatment (including SoC) + 30 days. The cycle of onset in which an AE first occurred in a patient at maximum grade was assessed. Results: The median duration of cycle of onset for cycles 1 to 5 was 6 weeks; for cycle 6, it was 26.6 weeks (Table). Of the 529 patients in the 177Lu-PSMA-617 group, 240 (45.4%) received ≤ 4 cycles and 289 (54.6%) received 5–6 cycles of treatment. In patients who received ≤ 4 or 5–6 cycles, 234 (97.5%) and 285 (98.6%) treatment-emergent AEs (TEAEs); 100 (41.7%) and 92 (31.8%) serious TEAEs; 205 (85.4%) and 246 (85.1%) treatment-related AEs; and 13 (5.4%) and 6 (2.1%) fatal TEAEs, respectively, were observed. Number of TEAEs and serious TEAEs by cycle of onset are shown in the Table. Conclusions: Over 50% of patients with mCRPC received 5–6 cycles of 177Lu-PSMA-617. For cycles 1–5, TEAEs occurred at every cycle, with similar frequency. More TEAEs were observed in cycle 6, reflecting its longer median duration than other cycles. Clinical trial information: NCT03511664. [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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.005 |
| 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) | 0.003 | 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".