<i>nab</i>-paclitaxel (<i>nab</i>-P) plus gemcitabine (Gem) vs Gem alone as adjuvant treatment for resected pancreatic cancer (PC) in a phase III trial (APACT).
Bibliographic record
Abstract
TPS4153 Background: Adjuvant chemotherapy for resected PC has been shown to decrease recurrence and increase survival. Gem alone is a standard adjuvant therapy option. nab-P + Gem was superior to Gem alone as first-line treatment in a phase III trial in patients (pts) with metastatic PC, including the primary endpoint of overall survival (median, 8.5 vs 6.7 months; HR 0.72; P < 0.001). Toxicities were manageable. Based on these findings in the metastatic setting, the APACT trial will compare nab-P + Gem vs Gem alone in the adjuvant setting. Methods: Pts with histologically confirmed PC who underwent macroscopic complete resection (R0 or R1) within 12 weeks of randomization, with no evidence of metastasis at screening, are eligible for enrollment. Other eligibility criteria include staging of T1-3, N0-1, M0; Eastern Cooperative Oncology Group performance status of 0 or 1; acceptable hematologic function; CA19-9 < 100 U/mL prior to randomization; and no prior neoadjuvant therapy or radiation for PC. Pts with neuroendocrine tumors, any other malignancy within 5 years of randomization, infection with HIV or hepatitis B or C, or prior neoadjuvant treatment or radiation therapy for PC are ineligible. The planned enrollment of ≈ 800 pts will allow 90% power to detect an HR for disease-free survival (DFS) of 0.74 at a 2-sided significance level of 0.05. One interim safety analysis and 2 interim efficacy analyses (the first for futility and the second for futility and efficacy) will be performed. Pt enrollment is ongoing. Clinical trial NCT01964430. Clinical trial information: NCT01964430. Planned N ≈ 800 Investigational arm nab-P 125 mg/m2 plus Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle × 6 cycles Control arm Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle × 6 cycles Randomization 1:1 Stratification factors Resection status (R0 vs R1) Nodal status (lymph node + vs lymph node −) Geographic region (North America vs Europe vs Australia vs Asia Pacific) Primary endpoint DFS (independently assessed) Secondary endpoints OS, safety Exploratory endpoints Molecular profiling of tumor tissue to correlate tumor heterogeneity with clinical outcome Quality of life as assessed by the EORTC questionnaires QLQ-C30 and QLQ-PAN26
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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 | 0.002 |
| 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 | 0.004 |
| 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".