The reliability of ductal lavage in women at high risk for breast cancer

Visvanathan, Kala; Santor, Deborah; Ali, Shatha Ahmed Mohammed; Brewster, Alison; Arnold, Antje; Armstrong, D. K.; Helzlsouer, Kathy J.

doi:10.1200/jco.2005.23.16_suppl.1001

Cited by 2 publications

(2 citation statements)

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“…First, DL provides cells from a specific duct system such that the finding of highly abnormal cells might be investigated via ductoscopy. Second, presuming the same duct can be reliably recannulated, DL has the potential to minimize sampling variance in prevention trials although this has not been observed in a small study reported in abstract form [25]. However, if an evaluable specimen cannot be obtained in a sizable proportion of high-risk subjects on whom the procedure is attempted, then DL becomes a less attractive procedure for risk assessment or prevention.…”

Section: Discussionmentioning

confidence: 96%

Comparison of cytomorphology in specimens obtained by random periareolar fine needle aspiration and ductal lavage from women at high risk for development of breast cancer

Zalles

Kimler

Simonsen

et al. 2005

Breast Cancer Res Treat

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Ductal lavage (DL) and random periareolar fine needle aspiration (RPFNA) are both being used to harvest epithelial cells for risk assessment as well as response evaluation in chemoprevention trials. The magnitude of increase in relative risk has been defined in a prospective study for RPFNA but not for DL atypia. We attempted both procedures in 26 women at high risk for development of breast cancer. Median age was 43 (range 32-57); 15 women were premenopausal, with 6 of the postmenopausal women on HRT. Collection of nipple aspirate fluid (NAF) was attempted and, if successful, was followed by DL; RPFNA was then performed on all women. Both procedures were attempted the same day (follicular phase of menstrual cycle if premenopausal) in 24 subjects and within three months for two subjects. Twenty-three subjects produced NAF, 17 of the 23 (74%) had a successful duct cannulation as part of the DL procedure, with 16 yielding sufficient (10) ductal cells for morphologic assessment. Twenty-five of 26 (96%) subjects had a successful RPFNA procedure with adequate cellularity for morphology. There was concordance between DL and RPFNA specimens for traditional cytologic category assessment in 10/16 (63%), Masood index score in 13/16 (82%), and Consensus Panel assessment in 12/16 (75%) of specimens. We conclude that same day DL and RPFNA is feasible, with 62% and 96% of high-risk women having a successful procedure with evaluable cytomorphology. RPFNA was more likely to yield an evaluable specimen, but if a cellular DL specimen was obtained, morphology was generally similar.

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Section: Discussionmentioning

confidence: 96%

Comparison of cytomorphology in specimens obtained by random periareolar fine needle aspiration and ductal lavage from women at high risk for development of breast cancer

Zalles

Kimler

Simonsen

et al. 2005

Breast Cancer Res Treat

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“…Bhandare and Khan that further studies with Ki-67 are required before it can be considered a validated risk biomarker, we would not agree that their experience with Ki-67 reproducibility in ductal lavage specimens would necessarily translate into RPFNA specimens. Ductal lavage often samples material from a single duct and there are multiple issues related to the ability to even repeatedly cannulate and harvest epithelial cells from the same duct over time (7). Furthermore, the low mean baseline level of Ki-67 in ductal lavage samples and the low minimum number (100) of ductal lavage epithelial cells required in Drs.…”

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confidence: 99%

Ki-67 Expression in Benign Breast Ductal Cells Obtained by Random Periareolar Fine Needle Aspiration

Bhandare¹

2005

Cancer Epidemiology, Biomarkers &Amp; Prevention

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To the Editors: Robust and reversible biomarkers are needed for the successful completion of phase II prevention trials, an area where Fabian and colleagues have made enormous contributions. One potential marker is cell proliferation, measured by Ki-67 labeling; Khan et al. present data obtained by random periareolar fine-needle aspiration in 147 women at high-risk, which they interpret as providing preliminary support for use of Ki-67 as a response biomarker in prevention trials (1). They base this on an association between morphologically defined hyperplasia with atypia, and Ki-67 labeling index. These results are based on a single random periareolar fine-needle aspiration procedure, so that a key attribute of a useful biomarker (reproducibility; ref.2) remains untested.Our experience at Northwestern University using ductal lavage for similar analyses has both similarities and differences to these data. In an ongoing phase II chemoprevention study with tamoxifen as the intervention agent, we found a mean Ki-67 labeling index in ductal lavage samples of 0.72% (based on results from 117 women with >100 cells at baseline lavage). Although we observed a good correlation of Ki-67 labeling index with total epithelial cell yield (P = 0.001), no correlation was seen with cytological atypia. In agreement with Khan et al., we see a very strong correlation between cytology and total cell number, and note with interest that when Khan et al. performed a multivariate analysis to predict Ki-67 expression, a significant correlation of Ki-67 with cytomorphology was seen only after cell number was excluded from the analysis. This, together with our own findings in relation to the correlation of cell number with biomarkers such as endoplasmic reticulum, cyclooxygenase-2, and Ki-67 expression, suggests that epithelial cell yield is at least as good a biomarker of response to preventive intervention as Ki-67 labeling.We have compared the mean Ki-67 labeling index in women who did not take tamoxifen with those who accepted tamoxifen therapy, at baseline and 6 months later. In the no-intervention group, Ki-67 labeling index dropped from 0.73 to 0.27 (P = 0.003) while in the tamoxifen group, comparable values were 0.55 and 0.37 (P = 0.35; ref. 3). In phase Ia and Ib studies of women with hormone receptorpositive breast cancer, Fabian et al. found no significant difference in Ki-67 labeling, although proliferating cell nuclear antigen -labeled cells decreased significantly following arzoxifene intervention (4).Considering these results together, we remain skeptical whether parameters such as Ki-67 labeling and morphological atypia are robust and reproducible indicators of response. In Response: Drs. Bhandare and Khan in their letter to the editor question whether Ki-67 labeling and cytomorphologic evidence of atypia in cytology specimens are sufficiently robust biomarkers to be used as response end points in early phase prevention trials. This is based on their experience with a limited number of ductal lavage specimens in which sampl...

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The reliability of ductal lavage in women at high risk for breast cancer

Cited by 2 publications

References 0 publications

Comparison of cytomorphology in specimens obtained by random periareolar fine needle aspiration and ductal lavage from women at high risk for development of breast cancer

Comparison of cytomorphology in specimens obtained by random periareolar fine needle aspiration and ductal lavage from women at high risk for development of breast cancer

Ki-67 Expression in Benign Breast Ductal Cells Obtained by Random Periareolar Fine Needle Aspiration

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