Association between progression-free survival (PFS) rate (PFSR) and overall survival (OS) in LUME-Meso, a study of nintedanib (N) vs. placebo (P) in combination with first-line pemetrexed/cisplatin (PEM/CIS) in patients (pts) with malignant pleural mesothelioma (MPM).
Bibliographic record
Abstract
8568 Background: We evaluated the relationship between PFSR and OS in the Phase II part of LUME-Meso, a double-blind, placebo-controlled study that showed improved PFS (primary endpoint; hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.34–0.91; p = 0.017), for N vs P; for OS HR = 0.77; 95% CI 0.46–1.29. Methods: Pts with unresectable MPM (ECOG PS 0–1), stratified by histology (epithelioid/biphasic), were randomized 1:1 to receive ≤6 cycles PEM (500 mg/m2)/CIS (75 mg/m2) on Day 1 + N or P (200 mg bid on Days 2–21), followed by N or P monotherapy maintenance. PFSR was defined as the proportion of pts who did not meet criteria for progressive disease (PD) at the specified time point (a ‘landmark analysis’). PFSR was assessed at 6 (PFSR6) and 8 (PFSR8) months. The association with OS was then evaluated based on the progression status at the landmark. Pts who died prior to the landmark were excluded from analysis. Results: 87 pts were randomized (N: 44; P: 43). The PFSR6 analysis included 71 pts (28 with PD and 43 without PD); subsequently there were 52 deaths. The PFSR8 analysis included 63 pts (32 with PD and 31 without PD); subsequently there were 45 deaths. There were more pts treated with N vs P who had not progressed at 6 (63% vs 37%) and 8 (71% vs 29%) months. Both PFSR6 and PFSR8 predicted OS (HR for PFSR6: 0.19; 95% CI: 0.11–0.35; HR for PFSR8: 0.18; 95% CI: 0.09–0.37). In the PFSR6 analysis, median OS was 22.8 months (95% CI: 15.6–28.4) in pts without PD prior to the landmark vs 6.1 months (95% CI: 3.3–7.0) in pts with PD prior to the landmark. In the PFSR8 analysis, median OS was 23.9 months (95% CI: 15.6–28.4) in pts without PD prior to the landmark vs 5.0 months (95% CI: 3.9–11.6) in pts with PD prior to the landmark. PFSR also predicted OS in pts with epithelioid histology at 6 months (n = 63; HR = 0.19; 95% CI: 0.10–0.36) and at 8 months (n = 57; HR = 0.20; 95% CI: 0.09–0.40). Conclusions: In our study in pts with MPM, landmark PFSR at 6 and 8 months predicts OS. These data are consistent with previously published findings. Phase III of LUME-Meso is ongoing (NCT01907100). 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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| 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".