Quality of life in a multicenter phase II trial of neoadjuvant full-dose gemcitabine, oxaliplatin, and radiation in patients with resectable or borderline resectable pancreatic adenocarcinoma.
Bibliographic record
Abstract
226 Background: Pancreatic cancer remains incurable for the great majority of patients afflicted with the disease. The purpose of this study was to evaluate health related quality of life (HRQoL) following neoadjuvant full dose gemcitabine, oxaliplatin and radiation therapy (30 Gy) for pancreatic adenocarcinoma in a multi-institutional Phase-II trial. Methods: Fifty-seven patients were evaluable for the HRQoL component of this trial that consisted of two cycles of neoadjuvant chemoradiation with gemcitabine and oxaliplatin followed by pancreatectomy and two additional cycles of adjuvant chemotherapy. The effects of therapy on HRQoL were evaluated using: EORTC-C30, EORTC-PAN26 and FACT-HEP. Results: There were 20 patients (35%) with untreated resectable and 37 (65%) with borderline resectable pancreatic cancer. Thirty-nine patients (69%) completed two cycles of preoperative chemotherapy and surgery, 26 (40%) underwent a pancreaticoduodenectomy and 9 (14%) a distal pancreatectomy. Twenty-six patients completed postoperative adjuvant therapy. The median age was 64 (range 42-82); patients younger than 65 had a higher global HRQoL score at 6 months (p=0.046) following the initiation of treatment. There was no difference in the HRQoL according to type of operation performed. EORTC-C30 Global HRQoL remained statistically and clinically unchanged compared to baseline levels at all time-points. FACT-Hep Trial Outcome Index and Total score showed a statistically significant but not clinically meaningful decline following cycle 2 of neoadjuvant treatment (p=0.002 and p=0.004), returning back to baseline levels after 6 months. This may in part be explained by a decrease in the functional (p=0.004) and physical (p=0.001) wellbeing, an increase in diarrhea (p=0.044), digestive symptoms (p=0.037) and an increased fatigue (p<0.001). Conclusions: We report that this neoadjuvant chemoradiation protocol did not have a clinical impact on global HRQoL. Overall this regimen was well tolerated with no negative effect on quality of life following the conclusion of treatment. Clinical trial information: NCT00456599.
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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 | 0.004 | 0.002 |
| 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".