Abstract P6-18-04: Ribociclib with a non-steroidal aromatase inhibitor and goserelin in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: MONALEESA-7 age subgroup analysis
Bibliographic record
Abstract
Abstract Background: Younger patients (pts) with breast cancer may experience more aggressive disease and are more likely to die from their cancer vs older pts. In the Phase III MONALEESA-7 study (NCT02278120), the addition of ribociclib (RIB; cyclin-dependent kinase 4/6 inhibitor) to a non-steroidal aromatase inhibitor (NSAI) or tamoxifen (TAM) + goserelin significantly prolonged progression-free survival (PFS) in premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC; hazard ratio 0.553; p<0.0001). RIB treatment benefit was observed irrespective of endocrine partner (NSAI or TAM). Here we report results from a MONALEESA-7 subgroup analysis in pts aged <40 yrs and ≥40 yrs who received RIB or placebo (PBO) in combination with an NSAI + goserelin. Methods: Pre- or perimenopausal women with HR+, HER2– ABC who had received no prior endocrine therapy and ≤1 line of chemotherapy for ABC were enrolled. Of the 672 pts randomized, 495 (74%) received RIB (600 mg/day, 3-weeks-on/1-week-off) or PBO + an NSAI (letrozole [2.5 mg/day] or anastrozole [1 mg/day]) and goserelin (3.6 mg every 28 days). The primary endpoint was locally assessed PFS; secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), and safety. A prespecified subgroup analysis was performed in pts aged <40 yrs and ≥40 yrs. Results: A total of 144 pts were aged <40 yrs (RIB vs PBO arm: 78 vs 66) and 351 were aged ≥40 yrs (170 vs 181). As of August 20, 2017, in the RIB vs PBO arms, treatment was ongoing in 50% vs 23% of pts aged <40 yrs and 54% vs 43% of pts aged ≥40 yrs; disease progression was the most common reason for treatment discontinuation (<40 yrs: 37% vs 68%; ≥40 yrs: 35% vs 44%). Median PFS was prolonged in the RIB vs PBO arms both in pts aged <40 yrs (not reached vs 10.8 months; hazard ratio 0.435; 95% confidence interval [CI] 0.276–0.686) and in pts aged ≥40 yrs (27.5 vs 19.1 months; hazard ratio 0.625; 95% CI 0.449–0.870). In pts with measurable disease, the ORR (RIB vs PBO arm) was 49% vs 32% in pts aged <40 yrs and 51% vs 38% in pts aged ≥40 yrs; CBR was 81% vs 61% and 82% vs 65%, respectively. The most common Grade 3 adverse events (AEs; ≥5% of pts in either arm; RIB vs PBO arm) were neutropenia (<40 yrs: 47% vs 5%; ≥40 yrs: 58% vs 3%), leukopenia (<40 yrs: 18% vs 2%; ≥40 yrs: 14% vs 1%), diarrhea (<40 yrs: 5% vs 0; ≥40 yrs: 1% vs 0), and increased alanine aminotransferase (<40 yrs: 4% vs 2%; ≥40 yrs: 5% vs 1%); neutropenia was the only Grade 4 AE occurring in ≥5% of pts in either arm (<40 yrs: 15% vs 0; ≥40 yrs: 8% vs 1%). New post-baseline QTcF >480 ms (RIB vs PBO arm) occurred in 3% vs 2% of pts aged <40 yrs and 7% vs 1% of pts aged ≥40 yrs. Conclusions: Consistent treatment benefit was observed with RIB + NSAI vs PBO + NSAI in premenopausal women with HR+, HER2– ABC irrespective of age. RIB + NSAI had a manageable safety profile in pts aged <40 yrs and in those aged ≥40 yrs, with a safety profile similar to that observed in the full study population. Citation Format: Tripathy D, Campos-Gomez S, Lu Y-S, Franke F, Bardia A, Wheatley-Price P, Cruz FM, Hegg R, Cardoso F, Gaur A, Kong O, Diaz-Padilla I, Miller M, Hurvitz S. Ribociclib with a non-steroidal aromatase inhibitor and goserelin in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: MONALEESA-7 age subgroup analysis [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-04.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| 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 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".