Erlotinib added to bevacizumab as maintenance therapy and health-related quality of life in patients with metastatic colorectal cancer: Results of the GERCOR DREAM phase III trial.
Bibliographic record
Abstract
3553 Background: The DREAM phase III clinical trial aimed to assess the efficacy and tolerability of maintenance bevacizumab (B) plus erlotinib (E) after a bevacizumab-based induction therapy in patients with unresectable metastatic colorectal cancer (Tournigand C. et al. Lancet Oncol. 2015). The addition of E to B improved maintenance progression-free survival (PFS) (median B: 4.9months; median B+E: 5.4 months; Hazard Ratio (HR) = 0.78 [0.68-0.96], P = 0.036) and overall survival (OS). This study presents the results of health-related quality of life (HRQoL) data (secondary endpoint). Methods: HRQoL was assed using EuroQoL EQ-5D generic questionnaire before maintenance randomization (T0), at 2 (T1) and 4 months (T2). Analysis of baseline missing data profile was done comparing responders to non responders according to baseline patients’ characteristics and OS. The longitudinal analysis of the visual analogue scale (VAS) of the EQ-5D was done with a linear mixed model (LMM) by including the arm, the time and their interaction. Time to HRQoL deterioration (TTD) was defined as the time from randomization to the first deterioration of 5-point at least of the VAS score as compared to T0. Univariate cox regression analyses were performed to estimate HR of the treatment effect with its 95% confidence interval. Results: Between 2007 and 2011, 700 patients were included. After induction therapy, 452 patients without disease progression were randomized in B arm (N = 228) or B+E arm (N = 224). Among them, 111 patients (24.5%) completed the EQ-5D at T0, 78 (17.3%) at T1 and 54 (11.9%) at T2. Effects introduced in the LMM were not significant: arm effect (coeff = 0.93 (ref = Arm A), P = 0.83), time effect (coeff = 0.25, P = 0.88) and treatment by time interaction (coeff = 1.80, P = 0.42) reflecting a similar HRQoL among arms throughout its measurement. Median of TTD was 4.5 months (2.7-NA) for B vs. 4.1 months (2.3-NA) for B+E (HR = 1.46 [0.67-3.19], P = 0.34). Conclusions: These HRQoL results suggest that the added value of erlotinib to bevacizumab is not associated with a HRQoL deterioration, while it allows to improve maintenance PFS and OS. Clinical trial information: NCT00265824.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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".