The impact of brain metastases on overall survival (OS) in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) clinical trials (CT) in advanced non-small cell lung cancer (NSCLC)
Bibliographic record
Abstract
8075 Background: NSCLC patients (pts) with brain metastases (BMet) commonly are excluded from participating in clinical trials (CTs), based on perceptions of inferior outcomes. We evaluated the validity of this exclusion criterion, by investigating the OS of stage IV NSCLC pts with (BMet) and without (non-BMet) a prior history of BMet recruited to NCIC CTG CTs. Methods: This pooled analysis utilized data from BR.18 (paclitaxel/ carboplatin [PC] ± MMPI [BMS275291]), BR.21 (erlotinib vs. placebo), BR.24 (PC± VEGFR TKI [AZD2171]). Each trial permitted entry of pts with neurologically stable BMet, provided they had been treated and off corticosteroids (BR.24), or either treated or not but without corticosteroids (BR.18), or on a stable corticosteroid dose (BR.21). The primary end-point of these analyses was OS, evaluated in the pooled pt cohorts stratified by treatment arm, and in each trial individually. Results: Of 1,349 stage IV pts, 131 had a history of BMet. Of these, 103 (78%) pts had cranial radiation prior to randomization and 15 (11%) prior craniotomy. The median age of the BMet cohort was 56yrs vs. 61yrs for non-BMet cohort. There was no difference in baseline PS (BMet: PS 0–1 vs. 2 vs. 3 =74% vs. 21% vs.5%; non-BMet: 81% vs. 16% vs. 4%, p=0.16), weight loss (p=0.73) or hemoglobin (p=0.80) between the two cohorts. Female gender (41% vs. 33%, p=0.04) and adenocarcinoma (66% vs. 51%, p=0.005) was more common in the BMet cohort. There was no OS difference between the BMet and non-BMet cohort in the pooled analysis, stratified by trial (HR 1.05, 95%CI 0.85–1.28, stratified log-rank p=0.67), or in multivariate analysis adjusted for baseline covariates (AHR 1.12, 95%CI 0.91–1.37, p=0.31). There was also no OS difference between BMet and non-BMet pts when evaluated in each individual trial separately. Conclusions: Pts with a prior history of BMet have a similar OS to those pts without BMet in NSCLC in NCIC CTG CTs. In neurologically stable pts, BMet, should not be an exclusion criterion, while discontinuation or stable dose of corticosteroids appears a reasonable eligibility requirement. No significant financial relationships to disclose.
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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 | 0.073 | 0.085 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.006 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".