培训资料王树森乳腺癌内分泌治疗.ppt

* NSABP, National Surgical Adjuvant Breast and Bowel Project. This slide displays the schema of NSABP B33. The presentation at this year’s breast cancer meeting is the first?report of the results from this study. Patients completing 5 years of tamoxifen were randomized to receive either placebo or exemestane treatment. Initially, the investigators designed the study to accrue 3000?patients. However, during the early part of the trial, after only 17?months and accrual of approximately one half of the planned patients, the results of the MA.17 study were announced. The results from MA.17 demonstrated that letrozole conferred a clinical benefit in this patient setting. The investigators determined that it was unethical to continue this trial. The MA.17 study results were made known to the patients, the trial was unblinded, and all patients were offered exemestane. Approximately one half of the placebo patients crossed over to receive exemestane. Overall, most of the patients actually ended up getting exemestane. * CCO would like to thank Terry P. Mamounas, MD, for his permission to use this figure. RR, relative risk. This next slide shows the effects of exemestane on overall survival. There is a slight trend for the patients who were given placebo to actually have better overall survival, but the difference between the 2 arms is not statistically significant. Of note, the total number of events is very low at this short reporting time (29?events). I would say that this study endpoint is dramatically underpowered, and any conclusions drawn on treatment impact on the overall survival of patients are premature. * * MA.17: Trial Design MA.17 is a phase 3 randomized, double-blind, placebo-controlled trial of letrozole in postmenopausal women with primary breast cancer completing approximately 5 years (4.5 to 6 years) of early adjuvant tamoxifen. Patients were randomized to receive either placebo or letrozole 2.5 mg orally, dailyfor 5 years. Stratification factors included