Pooled analysis of venous thromboembolism (VTE) from four trials of necitumumab and chemotherapy for stage IV non-small cell lung cancer (NSCLC).
Bibliographic record
Abstract
e20534 Background: Metastatic NSCLC is a recognized risk factor for VTE. Some systemic treatments may increase this risk further. Here, we present the risk of VTE and its prognostic significance in patients treated with chemotherapy (chemo) and the EGFR monoclonal antibody necitumumab (neci) for metastatic NSCLC. Methods: Four trials of 1st-line treatment for Stage IV NSCLC were included in this analysis. SQUIRE (N = 1079) and INSPIRE (N = 616) were randomized phase 3 studies of cisplatin/gemcitabine +/- neci in squamous NSCLC and cisplatin/pemetrexed +/- neci in non-squamous NSCLC, respectively. JFCL (N = 161) was a randomized phase 2 study of carboplatin/paclitaxel +/- neci in squamous NSCLC. JFCK (N = 61) was a single arm study of cisplatin/gemcitabine+neci in squamous NSCLC. VTE risk was explored in each study in univariate analyses. A Cox proportional hazards model with treatment as a fixed covariate and any VTE (prior Hx and/or on-treatment) as a time-dependent covariate was used for survival (OS) analyses. Results: On-treatment VTE across studies ranged from 3.6-8.3% for chemo alone and 3.8-13.2% for neci+chemo. Neci+chemo was associated with increased VTE risk in SQUIRE (Relative Risk [RR] 1.699; CI 1.09-2.65), INSPIRE (RR 1.58; CI 0.99-2.52), and JFCL (RR 1.04; CI 0.20-5.49) compared to chemotherapy alone. Previous Hx of VTE was the strongest predictor of VTE in SQUIRE (RR 2.63; CI 1.296-5.34) and INSPIRE (RR 1.62; CI 0.79-3.33). In SQUIRE, other baseline risk factors with RR > 1.00 included age > 65, Hb < 10 g/dL, BMI > 35 kg/m2, and current smoking. Occurrence of VTE at any time was not associated with shorter OS in randomised trials: HR 1.06; CI 0.85-1.33 (SQUIRE), HR 0.99; CI 0.76-1.27 (INSPIRE), HR 1.16; CI 0.56-2.41 (JFCL). Conclusions: VTE was more frequent in patients on neci+chemo vs chemo alone, but was not associated with shorter OS. Hx of VTE was the most significant risk factor for VTE occurrence. A pooled analysis of all 4 trials is pending.
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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 | 0.021 | 0.021 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.022 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".