Quality of life in a multicenter phase II trial of metastasectomy for intra- and extra-hepatic metastases from colorectal adenocarcinoma.
Bibliographic record
Abstract
e14573 Background: The combination of intra- and extra-hepatic metastases (IHM and EHM) from colorectal cancer (CRC) has traditionally been considered a contraindication for surgery. Currently there is a growing interest in resecting IHM and EHM. The purpose of this study was to evaluate the health related quality of life (HRQoL) of patients with IHM and EHM from CRC undergoing complete metastasectomy. Methods: Participants with any number of CRC IHM and up to 3 foci of EHM, resectable with RO intent were eligible for the HRQoL component of a Phase-II multi-institutional trial. The effects of therapy on HRQoL were evaluated using: EORTC-QLQ C30, EORTC-LMC21 and FACT-HEP at baseline, prior to surgery and at 4, 8 and 12 months following complete metastasectomy. Results were compared to baseline. >10% mean score change was considered a minimally important clinical difference (MICD). Results: Twenty-five participants were enrolled with a median age: 57 (range: 32-84) years. Protocol surgery was completed in 18/25 (72%) including 11/25 (44%) staged resections. Perioperative morbidity and mortality was 11/25 (44%) and 1/25 (4%), respectively. Median disease-free survival was 6 (range: 0-17) months. 22/25, 88% participants underwent perioperative chemotherapy. EORTC-QLQ C30 Global-HRQoL remained statistically and clinically unchanged compared to baseline at 4 and 8 months but had a MCID decrease at 12 months (mean score change: 15.3) that was not statistically significant. This was associated with a significant decrease in social and role functioning and an increase in fatigue, pain and dyspnea. FACT-Hep score was statistically lower at 4 months post surgery, without reaching a MICD. There was no difference in any of the subscales analyzed in regards to sex, age or the presence of peri-operative complications. Conclusions: Aggressive metastasectomy of multi-site CRC is feasible and safe. Despite disease recurrence in the majority of patients there was no significant deterioration of Global HRQoL as a result of treatment. There was a transient effect on symptoms including fatigue, pain dyspnea and role functioning, which improved by 12 months. Clinical trial information: NCT00606398.
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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 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".