PURPOSE: Short-term phase I and phase II breast cancer prevention trials require tissue acquisition at baseline and after intervention to evaluate modulation of potential biomarkers. Currently used tissue acquisition methods include ductal lavage (DL), random periareolar fine needle aspiration (RPFNA), and core needle biopsy. The optimum method to retrieve adequate samples and the most accepted method by study participants is not known. EXPERIMENTAL DESIGN: We compared RPFNA and DL as breast tissue acquisition methods for short-term breast cancer prevention trials by evaluating sample adequacy and tolerability in subjects who participated in two prospective phase II breast cancer prevention trials. Eighty-six women at increased risk for breast cancer were included in this study and underwent baseline DL and RPFNA. High risk was defined as having a 5-year Gail score of >1.67% or a history of atypical hyperplasia (AH), lobular carcinoma, or breast cancer. RESULTS: Median age was 54.5 years (range, 39-75 years); 75% of the women were postmenopausal. About 51% of the women yielded nipple aspiration fluid, and breast fluid samples via DL were retrieved in 73% of these subjects. Of these samples, 71% were adequate samples (greater than 10 epithelial cells). However, when the entire cohort was considered, only 31% of the subjects had adequate samples. RPFNA was also attempted in all subjects, and sample retrieval rate was 100%. Out of these, 96% of the subjects had adequate samples. In DL samples, AH rate was 3.7% was and hyperplasia (H) rate was 11.1%. In RPFNA samples, AH rate was 12.9%, and H rate was 24.7%. Cytology findings in RPFNA samples correlated with age, menopausal status, and breast cancer risk category (previous history of lobular carcinoma in situ). Both procedures were well tolerated, and no complications occurred among participants. CONCLUSIONS: Considering that the main end point for short-term prevention trials is the modulation of biomarkers, it is important to optimize adequate sample acquisition; therefore, RPFNA is a more practical option for future phase I and II breast cancer prevention trials compared with DL.
PURPOSE: Short-term phase I and phase II breast cancer prevention trials require tissue acquisition at baseline and after intervention to evaluate modulation of potential biomarkers. Currently used tissue acquisition methods include ductal lavage (DL), random periareolar fine needle aspiration (RPFNA), and core needle biopsy. The optimum method to retrieve adequate samples and the most accepted method by study participants is not known. EXPERIMENTAL DESIGN: We compared RPFNA and DL as breast tissue acquisition methods for short-term breast cancer prevention trials by evaluating sample adequacy and tolerability in subjects who participated in two prospective phase II breast cancer prevention trials. Eighty-six women at increased risk for breast cancer were included in this study and underwent baseline DL and RPFNA. High risk was defined as having a 5-year Gail score of >1.67% or a history of atypical hyperplasia (AH), lobular carcinoma, or breast cancer. RESULTS: Median age was 54.5 years (range, 39-75 years); 75% of the women were postmenopausal. About 51% of the women yielded nipple aspiration fluid, and breast fluid samples via DL were retrieved in 73% of these subjects. Of these samples, 71% were adequate samples (greater than 10 epithelial cells). However, when the entire cohort was considered, only 31% of the subjects had adequate samples. RPFNA was also attempted in all subjects, and sample retrieval rate was 100%. Out of these, 96% of the subjects had adequate samples. In DL samples, AH rate was 3.7% was and hyperplasia (H) rate was 11.1%. In RPFNA samples, AH rate was 12.9%, and H rate was 24.7%. Cytology findings in RPFNA samples correlated with age, menopausal status, and breast cancer risk category (previous history of lobular carcinoma in situ). Both procedures were well tolerated, and no complications occurred among participants. CONCLUSIONS: Considering that the main end point for short-term prevention trials is the modulation of biomarkers, it is important to optimize adequate sample acquisition; therefore, RPFNA is a more practical option for future phase I and II breast cancer prevention trials compared with DL.
Authors: Kari B Wisinski; Adrienne Faerber; Stephanie Wagner; Thomas C Havighurst; Jane A McElroy; Kyungmann Kim; Howard H Bailey Journal: Clin Med Res Date: 2013-04-11
Authors: Seema A Khan; Heather A Lankes; Deepa B Patil; Michele Bryk; Nanjiang Hou; David Ivancic; Ritu Nayar; Shahla Masood; Alfred Rademaker Journal: Cancer Prev Res (Phila) Date: 2009-02-17
Authors: Banu K Arun; Yun Gong; Diane Liu; Jennifer K Litton; Angelica M Gutierrez-Barrera; J Jack Lee; Lana Vornik; Nuhad K Ibrahim; Terri Cornelison; Gabriel N Hortobagyi; Brandy M Heckman-Stoddard; Kimberly B Koenig; Ricardo R Alvarez; James L Murray; Vicente Valero; Scott M Lippman; Powel Brown; Nour Sneige Journal: Breast Cancer Res Treat Date: 2016-06-10 Impact factor: 4.872
Authors: Jennifer T Loud; Anne C M Thiébaut; Andrea D Abati; Armando C Filie; Kathryn Nichols; David Danforth; Ruthann Giusti; Sheila A Prindiville; Mark H Greene Journal: Cancer Epidemiol Biomarkers Prev Date: 2009-03-31 Impact factor: 4.254
Authors: Jennifer T Loud; Ellen Burke Beckjord; Kathryn Nichols; June Peters; Ruthann Giusti; Mark H Greene Journal: BMC Womens Health Date: 2009-07-14 Impact factor: 2.809