Global, multicenter, open-label, randomized phase II trial comparing gemcitabine (G) with. G plus AGS-1C4D4 (A) in patients (pts) with metastatic pancreatic cancer (mPC).
Bibliographic record
Abstract
4031 Background: A is a fully human monoclonal antibody directed against prostate stem cell antigen (PSCA), a cell surface protein expressed on pancreatic cancer cells. Methods: Previously untreated pts with pathologically- confirmed mPC and ECOG performance status (PS) of 0-1 were randomized 1:2 to G (1000 mg/m2 IV over 30 minutes weekly x7, 1 week rest, then weekly x3 q4weeks) or G plus A (48 mg/kg loading dose, then 24 mg/kg q3weeks over 60 minutes IV), stratified by region (North America vs. Europe/Russia). Primary endpoint was 6-month (mo) overall survival (OS) in the intention-to-treat population. With a planned sample size of 185 pts, the study was designed to detect an improvement in 6-mo OS from 45% to 65% with 90% power and one-sided α=0.10. Tumor samples were collected for pre-planned secondary analyses by PSCA expression. Results: 196 pts (63 in G arm, 133 in G+A arm) were enrolled from 04/09-05/10 at 55 centers in U.S., Canada, Spain, France, and Russia. For G/G+A arms: median age 63/62 years, male 40/56%, PS 1 83/73%, deaths to date 73/67%. Grade 3/4 adverse events (G/G+A; %): any 63/78%, neutropenia 14/26%, thrombocytopenia 2/9%, and pulmonary embolism 2/6%. Tumor tissue was available from 118 pts (60%) for immunohistochemistry (IHC): 64 pts strong/moderate (pos) and 54 weak/no staining (neg) for PSCA. Efficacy data for 6-mo OS are shown in the table. Disease control rates (PR+SD) and 95% CI were 49% (36, 62) for G arm and 50% (41, 58) for G+A arm in the full population, and 57% (34, 78) for G arm and 70% (54, 83) for G+A arm in the PSCA pos population. Conclusions: The addition of A to G is well-tolerated and resulted in a trend toward improved 6-mo OS, primarily in patients with moderate or strong tumor PSCA expression. Follow-up is ongoing for secondary endpoints. Population 6-mo OS (%) (95% CI) Difference (95% CI) P value* G G+A (G+A) - A Full 44 (32, 58) 56 (47, 64) 11 (-4, 26) 0.07 PSCA pos 57 (34, 78) 74 (59, 87) 17 (-10, 42) 0.08 PSCA neg 32 (13, 57) 34 (19, 52) 3 (-25, 30) 0.42 PSCA not available 44 (23, 66) 55 (41, 68) 11 (-13, 35) 0.19 *One-sided Cochran-Mantel-Haenszel test.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".