Anticoagulation and bleeding: A pooled analysis of lung cancer trials of the National Cancer Institute of Canada Clinical Trials Group
Bibliographic record
Abstract
8065 Background: Clinical trials may mandate LMW heparin (LMWH) rather than coumadin (C) for patients (pts) requiring anticoagulation; lower risks of bleeding and drug-drug interactions are reported. Pts on lung cancer chemotherapy (CT) trials are at risk for venous thromboembolism and frequently are anticoagulated. Using data from three lung cancer trials conducted by NCIC CTG we analyzed bleeding in participating patients using LMWH, C or non-steroidal anti-inflammatories (NSAID). Methods: 3 lung cancer (small cell (SCCL) and non-small-cell (NSCLC)) trials with concomitant medication data were identified: BR18 (774 pts) compared BMS-275291 to placebo in NSCLC pts receiving 1st line platinum based CT, BR20 (107 pts) compared vandetanib to placebo in SCLC pts who had completed primary CT while BR21 (731 pts) compared erlotinib to placebo in 2nd or 3rd line NSCLC. Mantel-Haentzel test stratified by trial was used to analyse the prevalence of bleeding according to LMWH, C or NSAID usage. Analyses were also conducted including bleeding grade 3 or higher, stratified by treatment group. Logistic regression predicting bleeding was used to analyse the use of concomitant drugs adjusted on baseline characteristics (age, sex, performance status, creatinine, platelets). Results: Bleeding was associated with C (p = 0.014) in both the stratified by trial and by treatment received analyses. Bleeding grade 3 or higher (hemoptysis, CNS, gastrointestinal) was higher with C or LMWH and platelet higher than 100 during treatment, although only 37 pts had grade 3 or higher bleeding. C remained the only drug leading to significantly higher risk of bleeding (odds ratio 1.6 [95% Confidence Interval: 1.1 - 2.4], p = 0.02) in the adjusted analysis. Conclusions: C increases bleeding in lung cancer pts enrolled in clinical trials. Clinical trials should consider requiring LMWH usage rather than C if anticoagulation is required. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration AstraZeneca, Roche AstraZeneca
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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 | 0.029 | 0.063 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.009 | 0.019 |
| Bibliometrics | 0.006 | 0.011 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".