NCIC-CTG MA14 Trial: Tamoxifen (tam) vs. tam + octreotide (oct) for adjuvant treatment of stage I or II postmenopausal breast cancer

摘要: 532 Background: Our preclinical data (Cancer Res. 54:6334,1994) suggested mechanisms involving insulin/IGF physiology by which a somatostatin analogue + tam combination might be superior to alone for adjuvant BC therapy. Methods: In 1996, we began Phase 3 trial randomizing stage I or II postmenopausal patients 20mg daily 5 yr with without oct (monthly 90mg depot injection) yr, later reduced 2 due concern regarding cholelithiasis. Stratification factors included chemotherapy, axillary nodal status, and ER status. Primary endpoint was event-free survival (EFS), defined as time from randomization recurrence, second malignancy, death any cause, assessed the adjusted log-rank test statistic an step-wise forward Cox regression. Objectives studies of relevant biomarkers in relation treatment outcomes. Results: 667 women were accrued (333 tam, 334 +oct), median follow-up 7.9 years 220 events: 112 ...