Randomized trials of adjuvant tamoxifen versus tamoxifen and octreotide LAR in early-stage breast cancer: NCIC CTG MA.14 and NSABP B-29.
Bibliographic record
Abstract
538 Background: MA.14 and B-29 examined whether the addition of Octreotide (SMS 201-995 pa LAR; OCT) to 5 years adjuvant tamoxifen (TAM) prolonged disease-free survival (DFS). Excessive gallbladder (GB) toxicity in B-29 led to DMC recommended stopping of OCT and MA.14 shortening of OCT to 2 years. Data for the 2 trials were pooled. Methods: Median follow-up of the 667 MA.14 patients was 9.8 years, and of the 893 B-29 patients, 6.8 years for ITT analysis. The primary endpoint was DFS, defined as time from randomization to time of (local, regional or distant) breast cancer recurrence; any second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death. The primary test statistic was a pooled stratified log-rank test, with stratification within each trial by applicant stratification factors. Multivariate assessment was with Cox regression. Results: MA.14 patients were all postmenopausal with 97% ≥50 years of age while 62% of B-29 women were ≥50. 53% of MA.14 patients were lymph node negative (LN-), while all of B-29 patients were LN-. 33% of MA.14 patients received adjuvant chemotherapy, 2% concurrently, while 53% of B-29 received concurrent chemotherapy. 90% of MA.14 patients were hormone receptor positive while 100% of B-29 were positive. MA.14 patients experienced a 5 year DFS rate of 80% on TAM and 76% on TAM+OCT, while B-29 patients had a 5 year rate of 88% for both arms. The pooled 5 year rates were 85% and 83%. Pooled univariate stratified Cox HR of TAM+OCT to TAM was 0.99 (95% CI 0.81-1.20; p-value= 0.69). The HR for MA.14 was 0.93 (0.72-1.19; p= 0.50) and for B-29 was 1.09 (0.80-1.50; p=0.59). Multivariate pooled HR of TAM+OCT to TAM was 0.98 (0.81-1.20; p=0.84). Patients who were older (p=0.0006), and had higher T stage (p<0.0001) with LN+ (p=0.0008) had shorter DFS. Conclusions: OCT did not significantly improve DFS for women who were a broad spectrum of patients: pre- or post-menopausal, LN- or LN+, and received sequential, concurrent or no adjuvant chemotherapy. Neither study had the intended duration of OCT due to GB toxicity; thus, the results do not negate targeting the insulin - IGF-I receptor family.
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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 | 0.014 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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".