Analyses of updated overall survival (OS) and prognostic effect of neutrophil-to-lymphocyte ratio (NLR) and CA 19-9 from the phase III MPACT study of <i>nab</i>-paclitaxel (<i>nab</i>-P) plus gemcitabine (Gem) versus Gem for patients (pts) with metastatic pancreatic cancer (PC).
Bibliographic record
Abstract
4027^ Background: In the phase III MPACT trial, nab-P + Gem demonstrated superior OS vs Gem (primary endpoint; median 8.5 vs 6.7 months; HR 0.72; P< 0.001) with manageable toxicity in pts with metastatic PC. The primary analyses were based on a cutoff of Sep 17, 2012, at which time 80% of pts had died. Here, we report an updated OS analysis (post hoc) and an assessment of pts with elevated NLR or elevated CA 19-9 at baseline, 2 accepted markers of poor prognosis. Methods: 861 pts with metastatic PC and a Karnofsky performance status ≥ 70 were randomized at 151 community and academic centers 1:1 to receive nab-P 125 mg/m2 + Gem 1,000 mg/m2 on days 1, 8, and 15 of each 28-day cycle or Gem 1,000 mg/m2weekly for 7 wks followed by 1 wk of rest (cycle 1) and then days 1, 8, and 15 of each 28-day cycle (cycle ≥ 2). The data for the OS analysis were collected through May 9, 2013. Baseline NLR and CA19-9 were measured in blood samples collected before treatment. Results: As of the updated data cutoff, 380 of 431 pts (88%) in the nab-P + Gem arm and 394 of 430 pts (92%) in the Gem-alone arm had died. OS was superior for nab-P + Gem in the intent-to-treat (ITT) population, and longer follow-up identified > 3-yr survivors in the nab-P + Gem arm (Table). In a pooled–treatment-arm analysis, a NLR ≤ 5 was associated with longer OS vs a NLR > 5 (median 9.1 vs 5.0 months; HR 1.839; P < 0.001). Median OS was longer with nab-P + Gem vs Gem for pts with a NLR > 5 and pts with CA 19-9 > 59 × upper limit of normal (ULN; Table). Conclusions: Updated data confirmed the treatment effect favoring nab-P + Gem for OS. Additional follow-up has identified long-term survivors in the nab-P + Gem arm. The improved OS for pts treated with nab-P + Gem who have a NLR > 5 or an elevated CA 19-9 supports the relative benefit of the combination, even for pts with markers of poor prognosis. Clinical trial information: NCT00844649.Updated OS (May 9, 2013). nab-P+ Gem n = 431 Gem n = 430 HR P value ITT population Median OS, mo 8.7 6.6 0.72 < 0.001 OS rates by mo, % 6 66 55 12 35 22 24 10 5 36 4 — 40 3 — 42 3 — Subsets with markers of poor prognosis Median OS, mo NLR > 5 (n = 309) 5.6 4.3 0.81 0.079 CA 19-9 ≥ 59 × ULN (n = 392) 8.4 5.7 0.61 < 0.001
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".