Health-related quality of life (HRQoL) in patients with advanced neuroendocrine tumors (NET) of gastrointestinal origin in the phase 3 RADIANT-4 trial.
Bibliographic record
Abstract
285 Background: In the RADIANT-4 trial, everolimus (EVE) plus best supportive care (BSC) improved progression-free survival (PFS) compared to placebo (PBO) plus BSC in 302 patients with advanced progressive nonfunctional NET of gastrointestinal (GI) or lung origin (Yao, Lancet 2015) and in patients of GI origin only (Singh, ASCO-GI 2016). In addition, HRQoL was maintained with no statistically or clinically relevant differences in patients receiving EVE compared to PBO in the full sample (Pavel, ASCO 2016) and in patients with NET of GI origin (Pavel, NANETS 2016). Complementary analyses are presented to assess treatment effect on HRQoL in the subpopulation of patients with NET of GI origin. Methods: HRQoL was measured with FACT-G, a 27-item validated questionnaire with 4 domains: physical (PWB), social/family (SWB), emotional (EWB), and functional wellbeing (FWB). FACT-G was completed at baseline and every 8 weeks until month 12, then every 12 weeks until study drug discontinuation. Linear mixed models (LMM) were fitted to analyze mean FACT-G total (scale: 0 – 108) and subscale scores over time. A responder analysis in terms of cumulative distribution functions (CDF) of patients mean change from baseline across the entire study period was also conducted. Results: The subgroup of patients with NET of GI origin included 211 patients (141 on EVE and 70 on PBO) with NET of ileum, rectum, jejunum, stomach, duodenum, colon, caecum, appendix, or cancer of unknown primary (CUP), generally known as GI origin. In LMM, FACT-G total score at week 8 was 79.9 (95% CI: 77.7, 81.1) for EVE and 79.9 (95% CI: 77.0, 82.8) for PBO, declining to 77.1 (95% CI: 73.9, 80.4) and 78.7 (95% CI: 73.4, 83.9) at week 48. At each time point, differences in mean scores between treatment arms were lower than the minimally important difference (MID) of 7 points. Differences in mean subscale scores between treatment arms also did not exceed the MID (3 points). CDF plots showed no differences in distributions for the FACT-G total score (p = 0.9348). Conclusions: In addition to PFS benefits, HRQoL is maintained in patients with NET of GI origin receiving EVE despite usual toxicities of active cancer treatment. Clinical trial information: NCT01524783.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.002 |
| 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".