Tumor burden (TB) and treatment exposure (TE) in patients (pts) with malignant pleural mesothelioma (MPM) receiving nintedanib (N)/placebo (P) in combination with first-line pemetrexed/cisplatin (PEM/CIS) in phase II of the LUME-Meso study.
Bibliographic record
Abstract
8566 Background: In the double-blind, placebo-controlled phase II/III LUME-Meso trial, N was combined with up to 6 cycles of PEM/CIS, followed by N monotherapy until progression or toxicity. The primary analysis of phase II showed improved progression-free survival (primary endpoint) with N vs P (hazard ratio (HR) = 0.56; 95% confidence interval (CI): 0.34–0.91; p = 0.017); for overall survival HR = 0.77; 95% CI 0.46–1.29. We evaluated outcomes in the combination and monotherapy phases to understand better the overall study results. Methods: Pts with unresectable MPM (ECOG PS 0–1), stratified by histology, were randomized 1:1 to receive ≤6 cycles PEM (500 mg/m2)/CIS (75 mg/m2) Day 1 + N or P; 200 mg bid, Days 2–21), followed by N or P monotherapy maintenance. TE was analyzed for PEM/CIS, N and P. TB, measured using sum of diameter by modified RECIST 1.0, was analyzed over time, using a mixed-effects model in pts with at least two imaging datapoints. Results: 87 pts were randomized: 85 pts (N: 44, P: 41) were treated; 61 pts (N: 34, P: 27) received maintenance; median follow-up was 29 months. Both groups received a median of 6 cycles of PEM/CIS. In the combination phase, greater and longer reduction in TB was seen with N. Average TB reduction from baseline to nadir was 46% greater for N vs P (33.1 vs 22.6 mm). The nadir occurred at 4.1 vs 2.3 months for N vs P. In the monotherapy phase, treatment with N vs P showed markedly slower tumor regrowth from nadir (e.g. +46% vs +112% at 12 months). Median TE (N vs P) was 7.8 vs 5.3 months over the full treatment period. In the monotherapy phase, TE was 5.3 vs 2.8 months. The proportion of pts with serious AEs (N vs P) was similar between treatment groups during combination (34% vs 32%); during monotherapy the rate was 15% vs 26%. Conclusions: Pts receiving N had greater, more sustained reduction in TB than those receiving P and remained on active therapy for longer. AEs were manageable in both phases of the trial. Together with the primary study results, these analyses show that combination of N + PEM/CIS followed by N maintenance delivers clinical benefit to pts with MPM. Clinical trial information: NCT01907100.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".