Updated analysis of the NCIC CTG MA.17 randomized placebo (P) controlled trial of letrozole (L) after five years of tamoxifen in postmenopausal women with early stage breast cancer
Bibliographic record
Abstract
847 Background: Over half of recurrences and two thirds of deaths from hormone dependent breast cancer occur after completion of 5 years of adjuvant tamoxifen. We previously reported an improvement in disease free survival in women receiving extended adjuvant treatment with L after tamoxifen. Toxicities reported up until February 2003, 8 months prior to unblinding of the study medication, were low grade and included vasomotor symptoms, arthritis, joint and muscle pain. Hypercholesterolemia and cardiovascular events were similar in both arms and while new patient-reported diagnoses of osteoporosis were slightly more common (5.8% vs 4.5% L vs P), clinical fracture rate was unchanged by L. Methods: The study database was locked as of August 2003 for analysis of events in disease free survival (DFS) which were local or distant recurrence or new contralateral breast cancer. A subset analysis of outcome according to nodal status was performed. A full and updated analysis of all study endpoints, including safety and quality of life, as of the date of unblinding the trial (October 9 2003) will be conducted in mid-January 2004. Results: 5187 patients were randomized. Demonstration of an improvement in DFS was achieved earlier than anticipated (P = 0.00008 at the first interim analysis) with a hazard rate of 0.57, indicating a 43% reduction in risk. L decreased the risk of events by 53% and 40% for node negative and node positive patients respectively. This translated into an absolute improvement in 3-year disease free survival of 3% and 7% in node negative and node positive patients, respectively. Conclusions: Letrozole is indicated as extended adjuvant therapy for the majority of breast cancer patients completing about 5 years of tamoxifen regardless of nodal status. Further data from the updated analysis will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis; Pfizer Novartis; Pfizer AstraZeneca; Novartis
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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 | 0.009 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".