Comparison of Ductal Lavage and Random Periareolar Fine Needle Aspiration as Tissue Acquisition Methods in Early Breast Cancer Prevention Trials

Abstract

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.

Is There a Future for Ductal Lavage?

“…For their report, they combined the results of two pilot chemoprevention trials in which both ductal lavage and RPFNA were done as baseline tissue eligibility screening procedures in 86 women with a median age of 53 years. Their results in this largely postmenopausal cohort for whom both ductal lavage and RPFNA were attempted indicate that ductal lavage produces sufficient cells for cytomorphology analysis in 31% of women compared with 96% for RPFNA (14). The proportion with evaluable cytomorphology is lower than that reported by others for a mix of premenopausal and postmenopausal women (7, 9, 10, 15) but is within range of what others report for postmenopausal women (11).…”

“…In this issue, Arun et al (14) report that the efficiency of ductal lavage in producing evaluable benign epithelial specimens for chemoprevention trials in high-risk women is dramatically less than for RPFNA. For their report, they combined the results of two pilot chemoprevention trials in which both ductal lavage and RPFNA were done as baseline tissue eligibility screening procedures in 86 women with a median age of 53 years.…”

Short-Term Biomarker Modulation Prevention Study of Anastrozole in Women at Increased Risk for Second Primary Breast Cancer

“…The FNA procedure was carried out as previously described (11). Briefly, patients with previous history of breast cancer underwent the procedure in their intact opposite breast.…”

Molecular Analysis of Nipple Fluid for Breast Cancer Screening

“…Arun et al [11] recently reported that the efficiency of RPFNA in producing evaluable specimens for chemoprevention trials in high-risk women is higher than for ductal lavage, making RPFNA a more practical option for breast cancer prevention trials. Still, the invasiveness of the procedures may preclude a role in population-wide screening of high-risk women that requires repeated harvesting of material.…”