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 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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 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 | 0.000 | 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".