Reproducibility of ductal lavage cytology and cellularity over a six month interval in high risk women.
BACKGROUND
Ductal lavage (DL) allows repeat sampling of breast epithelium for serial observation in a chemoprevention setting; however, the reproducibility of duct cannulation, cell yield and cytology has not been addressed.


METHODS
We conducted a Phase 2 trial, wherein high risk women chose tamoxifen treatment or observation following an entry DL procedure. We present data from the non-intervention arm of our study to assess the reproducibility of cannulation, cell yield, and cytologic diagnosis from DL of the same duct at two time-points. Inter-observer variability was assessed by a blinded review of Papanicoloau-stained slides by two cytopathologists.


RESULTS
Sixty-five women had a successful lavage of 187 ducts at baseline and chose observation; 63/65 (97%) had a successful lavage 6 months later. Successful recannulation of the same duct was accomplished in 63 women (97%) and162 ducts (87%). Total epithelial cell yields >or=100 were obtained from 57/65 women (88%) and 129/187 ducts (69%) at baseline, and 46/63 women (73%) and 80/162 ducts (49%) at both time-points. Cytologic diagnosis was reproducible in 27/63 (43%) women and 77/162 (48%) ducts. Inter-observer variability for cytologic diagnosis between two observers showed good agreement (kappa = 0.62).


CONCLUSIONS
Recannulation and lavage of the same duct after a 6 month interval can be achieved with high frequency; however, reproducibility of cell yield and cytologic findings from the same duct is sub-optimal, leading to significant attrition of evaluable subjects. The utility of DL for the serial monitoring of breast epithelium is therefore limited.
Patil
Deepa B
DB
Department of Surgery, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
Lankes
Heather A
HA
Nayar
Ritu
R
Masood
Shahla
S
Bryk
Michelle
M
Hou
Nanjiang
N
Rademaker
Alfred
A
Khan
Seema A
SA
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000628:therapy; D003584:Cytological Techniques / Q000379:methods*; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D042361:Mammary Glands, Human / Q000473:pathology; D008875:Middle Aged; D009558:Nipples / Q000166:cytology / Q000473:pathology; D015588:Observer Variation; D015203:Reproducibility of Results; D012306:Risk; D013629:Tamoxifen / Q000627:therapeutic use*; D007507:Therapeutic Irrigation / Q000379:methods*
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen