ABSTRACT
Purpose@#Intraoperative frozen section biopsy is used to reduce the margin positive rate and re-excision rate and has been reported to have high diagnostic accuracy. A majority of breast surgeons in the Republic of Korea routinely perform frozen section biopsy to assess margins intraoperatively, despite its long turnaround time and high resource requirements. This study aims to determine whether omitting frozen section biopsy for intraoperative margin evaluation in selected patients is non-inferior to performing frozen section biopsy in terms of resection margin positivity rate. @*Methods@#This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial. Patients meeting the inclusion criteria and providing written informed consent will be randomized to the “frozen section biopsy” or “frozen section biopsy omission” group after lumpectomy. Patients with clinical stage T1–T3 disease who are diagnosed with invasive breast cancer by core-needle biopsy and plan to undergo breast-conserving surgery will be included in this study. If a daughter nodule, non-mass enhancement, or microcalcification is identified on preoperative imaging, these features must be within 1 cm of the main mass for inclusion in the trial. The target sample size is 646 patients per arm. The primary endpoint will be the resection margin positive rate, and the secondary endpoints include the reoperation rate, operating time, residual cancer after reoperation, residual cancer after re-excision according to the frozen section biopsy result, resection volume, patient quality of life, and cost-effectiveness.Discussion: This is the first randomized clinical trial utilizing frozen section biopsy for intraoperative margin evaluation and aims to determine the non-inferiority of omitting frozen section biopsy in selected patients compared to performing frozen section biopsy.We expect that this trial will help surgeons perform the procedure more efficiently while ensuring patient safety.
ABSTRACT
PURPOSE: The aim of this study is to evaluate the relationship of menopause and serum follicle stimulating hormone (FSH) level and estradiol (E2) in Korean women with breast cancer. METHODS: We reviewed 1,404 women aged from 20- to 82-year-old (median 47 years) with breast cancer who had got surgery at Asan Medical Center in 2008. All patients were checked serum FSH before the operation. Three hundred fifty-three patients were in postmenopause state at the time of surgery. Their ages were from 40- to 60-year-old (median 50.3 years). RESULTS: The proportion of postmenopausal status in each age-group were 5.1% (45- to 49-year-old), 41% (50- to 54-year-old), 86.1% (55- to 59-year-old), and 100% over the age of 60, respectively. And the proportion of the patients with FSH over 30 mUI/mL were 68.6% (45- to 49-year-old), 87.5% (55- to 59-year-old), 75.0% (55- to 59-year-old) and 30.0% (over the age of 60), respectively. CONCLUSION: Our study shows that even though patients had been in amenorrhea over 1 year, not all patients have their FSH level over 30 mUI/mL. And this finding is more prominent in age group from 45- to 49-year-old.