The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials
Bibliographic record
Abstract
8054 Background: Outcomes in lung cancer may differ by sex, with some studies reporting longer survival in women. Increased chemotherapy (CT) toxicity has been reported in women with small cell lung-cancer. We investigated the influence of sex on efficacy, toxicity, quality of life (QoL) and dose-delivery in NSCLC. Methods: This is a pooled analysis of three NCIC CTG phase III clinical trials: BR.10 (Stage I/II: adjuvant vinorelbine/cisplatin vs. observation), BR.14 (Stage IIIB/IV: vinorelbine/gemcitabine vs. gemcitabine/cisplatin or vinorelbine/cisplatin) and BR.18 (Stage IIIB/IV: carboplatin/paclitaxel plus BMS 275291 or placebo). Endpoints included overall survival (OS), progression free survival (PFS), response rate (BR.14 and BR.18 only), QoL, dose intensity (DI) and toxicity. Results: Of 1090 patients who received chemotherapy, 320 (29%) were women. At entry, women were more likely to have adenocarcinoma (70% vs. 44%, p<0.0001), be normal or underweight (60% vs. 49%, p<0.0001), and less likely to have anemia (29% vs. 55%, p<0.0001), diabetes or chronic lung disease compared to men. There were no significant differences in chemotherapy DI other than higher gemcitabine DI in women in BR.14, although there were trends for lower DI in women in BR.10, and more treatment delays and carboplatin omissions in BR.18. Women were less likely to have mild anemia and renal toxicity on treatment, but more likely to have mild nausea and vomiting. There were no differences in grade 3 or 4 toxicities. Response rates were similar in both sexes in BR.14 and BR.18 (27.4% vs. 31.2%, p = 0.27). Women had longer OS (HR 0.79 [0.67–0.93], p=0.007) and PFS (HR 0.79 [95% CI 0.68–0.92] p=0.002). In multivariate analyses, female sex remained a significant predictor of prolonged PFS, while anemia and non- squamous/adenocarcinoma pathology predicted shortened PFS; only anemia was predictive of shortened OS. There was no difference in global QoL changes. Conclusions: Women in these studies have a modest PFS benefit from CT for NSCLC, but no major differences in OS, response rate, DI, severe toxicity or QoL. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration OSI Oncology, Roche Lilly Oncology, OSI Oncology, Roche Roche
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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 | 0.054 | 0.069 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.007 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".