Preoperative trial of neoadjuvant abiraterone plus or minus cabazitaxel: Early results.
Bibliographic record
Abstract
98 Background: High-risk prostate cancer (PC) has a significant risk of recurrence when treated with unimodal therapy. The utility of neoadjuvant therapy, prior to RP has yet to be defined. The Princess Margaret Cancer Centres’ ACDC study investigates the application of agents used for castration resistant PC in the neoadjuvant setting by comparing the use of abiraterone (AA) + prednisone (P) + leuprolide (LHRH) with or without cabazitaxel (CA) prior to RP in 76 high-risk patients. Herein, we report early results and protocol modifications. Methods: This phase II trial will randomize patients to two treatment arms: Arm A (AA/P + LHRH + CA 25 mg/m2 with peg-filgrastim 6 cycles) or Arm B (AA/P + LHRH) for 6 months prior to RP. The primary objective is to compare the pathological complete response (CR) between the treatment arms. We present the RP outcomes and safety data for the first 13 participants. Results: Out of 13 randomized participants, 10 completed study procedures and underwent RP. One participant (Arm B) completed study drug treatment, but opted for radiation therapy, while 2 participants (both in Arm B) were discontinued due to hepatoxicity. At RP, 2 participants exhibited CR (1 in each group) and an additional 3 patients exhibited near CR (less than 5% tumor volume). The Table demonstrates patient characteristics, pathologic results and Grade 3 adverse events rates. Of note, 2 patients (both in CA arm) developed post-operative thrombo-embolic events post RP and two experienced febrile neutropenia. Conclusions: Early findings indicate significant tumor response with 50% of patients exhibiting CR or near CR. Reduction in dosage of Cabazitaxel to 20 mg/m2 as well as need for extended post-operative thromboembolic prophylaxis have been implemented. ACDC early outcomes. [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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 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".