196P Efficacy and safety of first-line (1L) ribociclib (RIB) + letrozole (LET) in patients (pts) with de novo metastatic disease and late recurrence from (neo)adjuvant therapy (tx) in MONALEESA (ML)-2
Bibliographic record
Abstract
In ML-2, RIB + LET demonstrated statistically significant overall survival (OS) vs placebo (PBO) + LET (median [m], 63.9 vs 51.4 mo) in postmenopausal pts with HR+/HER2− advanced breast cancer (ABC). Pts in ML-2 were in the 1L (no prior endocrine tx for ABC). Prior (neo)adjuvant tx was allowed; however, for pts treated with a prior nonsteroidal aromatase inhibitor, a treatment-free interval (TFI; time from end of [neo]adjuvant tx to disease recurrence) > 12 mo was required. Here we present a subgroup analysis of pts in ML-2 with de novo metastatic disease and late recurrence (TFI > 12 mo from end of any [neo]adjuvant tx). Pts in ML-2 were randomized 1:1 to 1L LET + RIB or PBO. Pts with de novo disease or late recurrence were analyzed for OS, progression-free survival (PFS), time to chemotherapy (TTC), and chemotherapy-free survival (CFS). Of 668 pts, 18.4% had TFI ≤ 12 mo and were excluded from the analysis. A total of 545 pts were analyzed; 41.7% had de novo disease and 58.3% had late recurrence. Among pts with late recurrence, mTFI was 52.8 mo; 271/318 (85.2%) had a disease-free interval (DFI; time from initial diagnosis to disease recurrence) > 5 y and 148/318 (46.5%) had a DFI > 10 y. Baseline characteristics, including percentage of pts with de novo disease and late recurrence (Table), were balanced between arms. mOS with RIB vs PBO was 69.2 vs 54.3 mo (HR, 0.75 [0.60-0.93]; P = .005). TTC (m, 54.1 vs 40.9 mo; P = .004) and CFS (m, 42.5 vs 36.1 mo; P = .002) both favored RIB vs PBO. Additional efficacy outcomes are shown in the table. No new safety signals were observed. This exploratory analysis of ML-2, which excluded pts with TFI ≤ 12 mo (known poorer prognosis in 1L), demonstrated an OS HR consistent with that for the overall population. mOS surpassed that in the overall population (RIB, 69.2 mo vs PBO, 54.3 mo: an ≈15-mo improvement with 1L RIB over PBO).
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".