Health-related quality of life of postmenopausal women with hormone receptor–positive, HER2- advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2.
Bibliographic record
Abstract
133 Background: In the MONALEESA-2 trial, ribociclib + letrozole significantly improved progression-free survival and showed higher overall response rates vs placebo + letrozole in hormone receptor–positive, HER2– advanced breast cancer. Here, we present key patient-reported outcomes including health-related quality of life (HRQoL). Methods: Six hundred sixty-eight patients were randomized (n = 334 for each treatment group). Patient-reported outcomes were evaluated during treatment and at progression using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23. Changes from baseline in all subscales were analyzed using a linear mixed-effects model, and time to 10% deterioration was compared between treatment arms using the stratified log-rank test. Results: Questionnaire adherence rates were high ( > 90%). During treatment, HRQoL (global health status/QoL score) was maintained and similar in both treatment arms. At progression/end of treatment, HRQoL worsened numerically in both arms. Time to definitive 10% deterioration of HRQoL was similar between treatment groups, slightly favoring the ribociclib + letrozole arm (hazard ratio, 0.944; 95% confidence interval, 0.720–1.237). No statistically or clinically relevant differences were observed for key symptoms using EORTC QLQ-C30 including fatigue, nausea, and vomiting. There was clinically relevant improvement ( > 5 points) in pain from baseline to post baseline (through cycle 15) in the ribociclib + letrozole arm, but only mild improvement (≤5 points) in the placebo + letrozole arm. Conclusions: Ribociclib + letrozole maintained HRQoL, and a numerical trend favoring ribociclib + letrozole was observed for pain reduction and delay. Clinical trial information: NCT01958021.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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".