A multicenter phase III comparison of docetaxel (D) + prednisone (P) and mitoxantrone (MTZ) + P in patients with hormone-refractory prostate cancer (HRPC)
Bibliographic record
Abstract
4 Background: Docetaxel-based regimens have shown encouraging anti-tumor activity in phase II trials in HRPC. This study compared two schedules of D+P to MTZ+P, an accepted standard in HRPC. Methods: Patients (pts) with histologically-proven metastatic HRPC, testosterone <50 ng/ml, adequate hematologic and organ function, clinical and/or biochemical (PSA) progression, and no antiandrogens within 6 wk, were stratified by pain and KPS and randomized to daily prednisone (5mg po bid) plus D (ARM A-75mg/m2 q3wk x 10 cycles; ARM B-30mg/m2/wk x 5 of 6 wk x 5 cycles) or MTZ (ARM C-12mg/m2 q3wk x 10 cycles). Primary endpoint was survival; secondary endpoints included PSA response (≥50% decrease for at least 4 wk), pain response, and toxicity. A modified Bonferroni method was used to adjust for multiple comparisons. Results: 1,006 pts were randomized. Median follow up was 20.7 mo. Pts in all arms had similar baseline characteristics. Planned treatment was delivered to 98%, 96% and 99% pts in A, B, and C, respectively. Grade 3/4 toxicities (% pts A, B, C): overall (45.8%, 43.0%, 34.6%), including bone pain (7.8%, 7.3%, 9.9%), infection (5.7%, 5.5%, 4.2%), fatigue (4.5%, 5.5%, 5.1%), and diarrhea (2.1%, 4.8%, 1.2%). The most common laboratory grade 3/4 toxicity was neutropenia (32.0%, 1.5%, 21.7%). Conclusions: The D q3wk +P schedule improved overall survival and increased pain response and PSA response vs MTZ+P. It was well tolerated, but with more grade 3/4 neutropenia than MTZ+P. This is the first phase III study to show a significant survival benefit in HRPC. (Supported by Aventis) Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Aventis Research
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".