A phase II study of pre- and post-operative gemcitabine and erlotinib plus pancreaticoduodenectomy (PD) for patients with resectable pancreatic ductal adenocarcinoma (PDAC): ACOSOG Z5041 trial (Alliance).
Bibliographic record
Abstract
4112 Background: For resectable PDAC (without vascular involvement) postoperative adjuvant therapy remains the standard, though there is considerable interest in a neoadjuvant approach. This study evaluates overall survival (OS) with perioperative gemcitabine + erlotinib (G+E) combined with PD for resectable PDAC. Methods: ACOSOG Z5041 was a prospective, multicenter, single-arm phase II trial of pre- and postoperative G+E for resectable PDAC. Key eligibility requirements were localized biopsy-confirmed PDAC in the pancreatic head, resectable without evidence of tumor involvement of major mesenteric vessels. Patients (pts) received standard G+E (100 mg days 1-43) prior to and following surgery. The primary endpoint was 2-year overall survival (OS); secondary endpoints included toxicity profile, response rate, resection rate and time to progression. The study was closed early due to slow accrual; no formal hypothesis testing was performed. Results: 116 meeting eligibility requirements were enrolled; 114 who initiated treatment were evaluable. By central radiologic review, 97 pts met protocol resectability criteria, 17 pts were beyond. Median age was 66 years (39-88); 55 females (48%). Grade 3+ toxicity was reported in 68 (60%) and 90 (79%) pts during the neoadjuvant phase and overall. 22 (19%) pts did not proceed to surgery. 92 (81%) pts had surgery; 83 (73%) were resected with PD, 9 (8%) were unresectable. R0 and R1 margins were 67 (81%) and 15 (18%) of resected pts, respectively. 54 received postoperative G+E (65% resected, 47% evaluable). 2-year OS for evaluable pts was 40% (95%CI 31-49%) with median OS 21.3 (95%CI 17-26) months. 2-year OS for resected pts was 52% (95%CI 37-59%) with median OS 25.4 (95%CI 22-30) months. Conclusions: For resectable PDAC, neoadjuvant therapy provides 2-year OS similar to pts able to receive standard adjuvant therapy. Importantly, futile PD was avoided in 27% pts. Further evaluation of neoadjuvant therapy in resectable PDAC is warranted as more active chemotherapy regimens emerge. Support: U10CA180821, U10CA180882; Clinical trial information: NCT00733746.
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".