Adjuvant treatment and outcomes in patients with stage III colon cancer (CC) who do not fit clinical trial eligibility criteria (CTEC).
Bibliographic record
Abstract
486 Background: Trials have strict inclusion and exclusion criteria to maintain internal validity. However, study findings are often applied to pts in clinical practice who do not satisfy all of the CTEC. Whether these pts benefit from treatment is unclear. Our objectives were 1) to characterize cancer-specific (CSS) and overall survival (OS) in a population-based cohort of trial-eligible (TE) and trial-ineligible (TI) pts receiving adjuvant chemotherapy (CT) and 2) to compare their outcomes with those not treated with CT. Methods: Pts diagnosed with stage III CC between 2006 and 2008, referred to 1 of 5 regional cancer centers in British Columbia, and evaluated for possible adjuvant CT within 12 weeks of curative surgery were reviewed. Pts were defined as TE if aged 18 to 79 years, ECOG 0 to 1, CEA <10 ng/ml, had not received prior CT or radiation, and had adequate blood counts, cardiac, liver, and kidney function. All other pts were considered TI. Using Kaplan-Meier and Cox regression analyses, we compared outcomes between TE and TI pts who received CT vs. those who did not. Results: A total of 821 pts were identified: median age was 68 years, 52% were men, 85% were ECOG 0 to1, and 71% received adjuvant CT. Among pts treated with CT, 405 (70%) were TE and 177 (30%) were TI. Compared to TI pts, those who were TE were younger (p<0.01) and more likely to receive FOLFOX than capecitabine (65 vs. 46%, p<0.01). CSS and OS were significantly different among pts who were TE, TI, and those who did not receive CT (p<0.01) (Table). In multivariate analyses that adjusted for confounders, both TI pts and those not treated with CT had worse prognoses than TE pts (HR for CC deaths 1.32, 95%CI 0.86-2.02 and 2.77, 95%CI 1.92-3.99, respectively, p trend <0.01; HR for all deaths 1.24, 95%CI 0.85-1.80 and 2.95, 95%CI 2.17-4.00, respectively, p trend <0.01). Conclusions: A considerable number of stage III CC pts who did not fit CTEC were treated with adjuvant CT. While outcomes in the TI group were worse than those in the TE group, CSS and OS were still better than the subset that did not receive any CT. [Table: see text]
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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 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".