Phase III randomized anastrozole exercise (RAE) trial: First planned interim analysis
Bibliographic record
Abstract
e20674 Background: Adjuvant anastrozole (aA) is associated with arthralgias/myalgias (A/M), bone density loss, and hot flushes. Analgesics offer limited relief of musculoskeletal (MSK) symptoms and are associated with side effects of their own. The benefit of exercise on bone health, muscle strength, hot flushes, and quality of life (QOL) has been demonstrated; the objective of this trial is to determine if an exercise program improves anastrozole related A/M. Methods: This is a phase III, randomized trial of standard of care (observation) vs 48 weeks (wks) of exercise for women with BC on aA. Subjects in the control group receive literature about AIs (information on bone health, management of SEs of AIs). Subjects in the intervention group participate in a semi-supervised, individualized, and graduated 3x/wk exercise program (aerobic, resistance training, stretching) for 24 wks. From wks 25–48 independent exercise is recommended 3x/wk. The 10 endpoint is change in MSK symptoms as measured by 12 wk SF-36v2 bodily pain scores, NCI CTG toxicity, and visual analogue scale. 20 endpoints are QOL, hot flushes, bone density, and body mass. Physical activity and compliance with aA was monitored in both arms. The 1st interim analysis was planned after 10 patients were enrolled to evaluate accrual, compliance, and rate of discontinuation. Results: Accrual commenced December, 2007. Fourteen of a planned 72 patients have been enrolled (baseline data available for 13); 7 pts in the control arm (A) and 6 in the exercise arm (B). Median age was 59 (A) and 58 (B). Nine pts had baseline and 12 wk data available [5 (A), 4 (B)]. There were no withdrawals and compliance with scheduled exercise was 100%. Of the NCI CTG A/M deemed probably/definitely related to aA, there is no change in the number reported at baseline vs wk 12 in Arm A. In Arm B, 2 of 4 pts report a decrease in the number of A/M at wk 12. Mean norm-based wk 12 SF-36v2 bodily pain domain scores worsened by 4.1 in Arm A; an improvement of 1.9 in mean scores was observed in Arm B. Conclusions: Interim results show that a structured exercise program is well tolerated and compliance is high among women with aA related MSK symptoms. Early results point to a positive impact of exercise on MSK symptoms in women with early BC. Updated data will be presented. [Table: see text]
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.003 |
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".