BOLERO-2: Everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone receptor-positive breast cancer.
Bibliographic record
Abstract
540 Background: Estrogen-receptor–positive (ER+) breast tumors can become refractory to aromatase inhibitor (AI) therapy. The mTOR pathway plays a critical role in hormone-resistant advanced breast cancer (ABC). Accordingly, the addition of everolimus (EVE) to exemestane (EXE) was evaluated in an international, phase III study (BOLERO-2) in patients with ER+ aBC refractory to letrozole or anastrozole. This report presents updated analyses from the population of Asian patients enrolled in this study. Methods: Eligible patients were randomized (2:1) to EXE (25 mg/day) with EVE (10 mg/day) or with matching placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, quality of life, and safety. Results: EVE + EXE significantly improved PFS versus EXE alone (HR = 0.44; 95% CI, 0.36-0.53; P < .0001) in the overall study population at median follow-up of 12.5 months. Of 143 patients of Asian origin (n = 106; 74% Japanese) enrolled in this study, 98 received EVE + EXE and 45 received EXE + placebo. At the time of database lock, 55 Asian patients (56%) in the combination arm had experienced disease progression compared with 34 patients (76%) in the EVE + placebo arm. Combination therapy reduced the risk of disease progression versus EXE alone by 44% among Asian patients (HR = 0.56; 95% CI, 0.37-0.87; P < .05). Commonly reported adverse events in the combination arm were consistent with previous clinical studies of mTOR inhibitors and included stomatitis (80%), rash (49%), dysgeusia (31%). Adverse events that occurred more frequently in the Asian subset versus Caucasians included stomatitis (80% vs 54%) and rash (49% vs 37%), whereas dyspnea (8% vs 24%) and asthenia (1% vs 17%) occurred less frequently in the Asian subset versus Caucasians. Conclusions: The addition of EVE to EXE significantly prolonged PFS in Asian patients versus EXE alone. Adverse events were higher in the combination arm but generally manageable. Combining EVE with an AI is a safe and effective treatment option for Asian women with non-steroidal AI resistant/refractory ER+ ABC.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".