Effect of low-dose tamoxifen after surgical excision of ductal intraepithelial neoplasia: results of a large retrospective monoinstitutional cohort study.

Abstract

BACKGROUND:

Postsurgical treatment of ductal intraepithelial neoplasia (DIN) with standard doses of tamoxifen has not reached a consensus yet. Given positive results of low-dose tamoxifen on breast cancer biomarkers modulation, we analyzed a large cohort of DIN patients treated with low-dose tamoxifen or no treatment as per institutional guidelines.

PATIENTS AND METHODS:

All consecutive women operated on at the European Institute of Oncology for estrogen receptor (ER)-positive DIN (474 treated with low-dose tamoxifen and 509 untreated patients) were followed up for a median of 7 years.

RESULTS:

Compared with untreated patients, a significant 30% reduction in breast cancer risk was observed on low-dose tamoxifen with an adjusted hazard ratio (HR) = 0.70 [95% confidence interval (CI) 0.51-0.94], with a greater benefit in postmenopausal (HR = 0.57; 95% CI 0.34-0.94) than in premenopausal women (HR = 0.79; 95% CI 0.54-1.17). Treated patients with ER and progesterone receptor (PgR) >50% DIN had a lower incidence of breast events than untreated ones (HR = 0.61; 95% CI 0.40-0.94), whereas no protective effect has been observed in patients with ER or PgR <50% DIN. Drug discontinuation resulted in a doubled risk of recurrence in premenopausal women only (HR = 1.95; 95% CI 0.98-3.89). No excess of endometrial cancer occurred.

CONCLUSIONS:

Low-dose tamoxifen is a promising and safe strategy for highly endocrine responsive DIN. Treatment adherence is crucial in premenopausal women. A definitive trial is ongoing.

• Authors: A Guerrieri-Gonzaga, M Lazzeroni, E Botteri, D Serrano, N Rotmensz, M-C Varricchio, M Cazzaniga, G Bollani, S Mora, C Montefrancesco, G Pruneri, G Viale, M Intra, V Galimberti, A Goldhirsch, V Bagnardi, B Bonanni, A DeCensi
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 24 Issue 7 Pg. 1859-1866 (Jul 2013) ISSN: 1569-8041 [Electronic] England
• PMID: 23532115 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Hormonal
• Tamoxifen

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (administration & dosage)
• Breast Neoplasms (drug therapy, pathology, surgery)
• Carcinoma in Situ (drug therapy, pathology, surgery)
• Carcinoma, Ductal, Breast (drug therapy, pathology, surgery)
• Chemotherapy, Adjuvant
• Clinical Trials as Topic
• Disease-Free Survival
• Female
• Humans
• Kaplan-Meier Estimate
• Mastectomy, Segmental
• Middle Aged
• Neoplasm Recurrence, Local (prevention & control)
• Retrospective Studies
• Tamoxifen (administration & dosage)
• Treatment Outcome