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Annals of Oncology Advance Access published online on October 25, 2009
Annals of Oncology, doi:10.1093/annonc/mdp408
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Low-dose tamoxifen in the treatment of breast ductal intraepithelial neoplasia: results of a large observational study

A. Guerrieri-Gonzaga1, E. Botteri2, M. Lazzeroni1,3, N. Rotmensz2, A. Goldhirsch4, C. Varricchio1, D. Serrano1, M. Cazzaniga1, F. Bassi5, A. Luini5, V. Bagnardi2, G. Viale6,7, S. Mora1, G. Bollani1, E. Albertazzi2, B. Bonanni1 and A. Decensi1,8,*

1 Division of Cancer Prevention and Genetics
2 Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan
3 Department of Oncology, University of Rome Tor Vergata School of Oncology, Rome
4 Department of Medicine
5 Division of Breast Surgery
6 Division of Pathology, European Institute of Oncology, Milan
7 Department of Pathology, University of Milan School of Medicine, Milan
8 Division of Medical Oncology, Galliera Hospital, Genoa, Italy

* Correspondence to: Dr A. Decensi, Division of Medical Oncology, Galliera Hospital, Mura Le Capuccine 14, 16128 Genoa, Italy. Tel: +39-0105634501; Fax: +39-01057481090; E-mail: andrea.decensi{at}galliera.it

Background: Tamoxifen's cost–benefit ratio for breast ductal intraepithelial neoplasia (DIN) is unclear. Since low-dose tamoxifen showed a favorable modulation of breast cancer biomarkers in phase II trials, a monoinstitutional cohort of women with DIN treated with low-dose tamoxifen or no systemic treatment was analyzed.

Patients and methods: A total of 309 patients with DIN received low-dose tamoxifen as part of institutional guidelines and were compared with 371 patients with DIN who received no systemic treatment after surgery.

Results: Women with estrogen receptor (ER)/progesterone receptor (PgR) >50% DIN who were not treated had a higher incidence of breast events than women on tamoxifen [hazard ratio (HR) 1.76; 95% confidence interval (CI) 1.00–3.12] or women with ER/PgR <50% DIN (HR 1.72; 95% CI 1.14–2.58). Among untreated patients with ER >50% DIN, recurrence was higher in PgR ≥50% DIN than in PgR <50% DIN, whereas it was similar among low PgR (<50%) DIN against which tamoxifen had no effect. No difference in endometrial cancer incidence was noted.

Conclusions: High ER and especially high PgR expression is a significant adverse prognostic indicator of DIN, and low-dose tamoxifen appears to be an active treatment. Women with low-expression ER or PgR DIN do not seem to benefit from tamoxifen. A definitive clinical trial is warranted.

breast cancer, DCIS, ductal intraepithelial neoplasia, low-dose tamoxifen

Received for publication July 3, 2009. Accepted for publication July 14, 2009.


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