Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC): MONALEESA-7 patient-reported outcomes (PROs)
Bibliographic record
Abstract
Background: In the Phase III MONALEESA-7 trial (NCT02278120), RIB + TAM/NSAI + goserelin (GOS) significantly improved progression-free survival vs placebo (PBO) + TAM/NSAI + GOS in premenopausal pts with HR+, HER2– ABC; here we report key PRO data. Methods: Pre/perimenopausal pts (N = 672; ≤1 line of prior chemotherapy and no prior endocrine therapy for ABC) were randomized 1:1 to RIB (600 mg/day; 3 weeks on/1 week off) or PBO + TAM (20 mg/day) or an NSAI (letrozole [2.5 mg/day]/anastrozole [1 mg/day]) + GOS (3.6 mg every 28 days). Primary endpoint: PFS. PROs were a secondary endpoint and were evaluated using EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, and WPAI-GH questionnaires. Changes from baseline and time to 10% deterioration (TTD) in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively. Results: Questionnaire compliance was high (>75%). On-treatment HRQoL (EORTC QLQ-C30 global health status/QoL score) was maintained up to Cycle (C) 17 in both arms. From C18 onwards, HRQoL improved in the RIB arm (clinically meaningful improvements [>5 points] at C5 and from C19 to C31), but numerically worsened in the PBO arm. Median TTD in HRQoL was not reached (NR) in the RIB arm (95% CI 22.2–NR) vs 21.2 months in the PBO arm (95% CI 15.4–23.0; hazard ratio 0.699; 95% CI 0.533–0.916; p = 0.004). EORTC QLQ-C30 physical, social, and role functioning domains, and WPAI-GH % work time missed were maintained in the RIB arm; physical and role functioning were maintained for a longer duration in the RIB vs PBO arm. WPAI-GH % activity impairment was maintained in the RIB vs PBO arm. Reductions in EORTC QLQ-C30 pain score were observed up to C28 in the RIB arm and up to C17 in the PBO arm; clinically meaningful reductions were observed in the RIB arm from C3 to C11 and C22 to C28. Conclusions: RIB + TAM/NSAI + GOS improves HRQoL and maintains functioning, work productivity, and activity in premenopausal pts with HR+, HER2– ABC. RIB + TAM/NSAI + GOS is also associated with a clinically meaningful reduction in pain vs PBO + TAM/NSAI + GOS. Clinical trial identification: NCT02278120, 29 October 2014. Editorial acknowledgement: Bhavika Modasia PhD of ArticulateScience Ltd. Legal entity responsible for the study: Novartis Pharmaceuticals Corporation. Funding: Novartis Pharmaceuticals Corporation. Disclosure: N. Harbeck: Personal fees for lectures/consulting: Eli-Lilly, Novartis, Pfizer, during the conduct of the study. P. Wheatley-Price: Personal fees for advisory boards: Novartis, AstraZeneca, Lilly Oncology, Bristol-Myers Squibb, Merck, Takeda, during the conduct of the study. B. Lanoue: Employed by Novartis Pharmaceuticals Corporation, during the conduct of the study. J. Alam: Employment: Novartis. D. Chandiwana: Employment and stock ownership: Novartis. M. Colleoni: Fees for advisory boards: AstraZeneca, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, and Celldex; Honoraria: Novartis, outside the submitted work. All other authors have declared no conflicts of interest.
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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) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| 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) | 0.000 | 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".