Randomized phase II-III study of matrix metalloproteinase inhibitor (MMPI) BMS-275291 in combination with paclitaxel (P) and carboplatin (C) in advanced non-small cell lung cancer (NSCLC): NCIC-CTG BR.18
Bibliographic record
Abstract
7038 Background: BMS- 275291 is a broad spectrum MMPI that was not associated with the dose-limiting joint toxicity seen with other MMPIs in phase I studies. Methods: Chemotherapy-naive patients with Stage IIIB/IV NSCLC, performance status (PS) 0–2 and adequate organ function were eligible. All patients received P (225 mg/m2) + C (AUC 6) IV q21d (max 8 cycles), and were randomized (double-blind) to receive BMS-275291, 1200 mg PO daily or placebo until disease progression. The primary study endpoint was survival (OS); secondary endpoints included progression-free survival (PFS), response rates (RR), toxicity, and quality of life (QoL). Results: From 2000 to 2002, 774 pts were randomized from 76 centres in North America and Europe (planned accrual 750 in 26 m). Pretreatment characteristics were well balanced between arms: median age 61; male 73%; stage IV 79%; PS 0/1 88%. 614 deaths have occurred, with median follow-up of 18 mos. Interim analysis revealed no survival advantage and increased toxicity in the experimental arm, and study treatment was stopped. Median OS in the final analysis was 8.6 mos in the BMS-275291 arm, 9.2 mos in the control arm (p=0.3). Median PFS and RR were 4.9 mos, 25.8% in the BMS 275291 arm, and 5.3 mos, 33.7% in the control arm. Toxicity was significantly higher in the BMS-275291 arm vs control: flu-like symptoms 8.1% v 4.5%; hypersensitivity reactions 8.6% vs. 2.4%; febrile neutropenia 9.7% vs. 5.5%; rash 12.2% vs. 0.8%; treatment stopped for toxicity 33.3% vs 23.5%. QoL scores during chemotherapy were similar in both arms, with deterioration in the experimental arm post-chemotherapy. Conclusions: BMS-275291 added to chemotherapy increases toxicity and does not improve survival in advanced NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".