Exemestane as neoadjuvant hormonotherapy for locally advanced breast cancer: results of a phase II trial

Anticancer Res. 2007 Jul-Aug;27(4C):2689-96.

Abstract

Background: Neoadjuvant hormonotherapy has recently been used for downstaging large or locally advanced (LA) breast cancer in postmenopausal women.

Patients and methods: A phase II study was conducted in postmenopausal, hormone-receptor (HR) positive, T2-T4 patients, receiving 25 mg/day exemestane for 16 weeks.

Results: Among 42 patients, 57.1% underwent conservative surgery. The clinical objective response rate (ORR) was 73.3%, without progression. A pathological partial response was achieved in 16.7% of the patients. Exemestane significantly reduced the expression of Ki-67 and progesterone receptors (PgR) (p<0.001). A significant decrease in PgR was correlated with clinical ORR (p=0.028). The responders presented higher baseline PgR levels (p=0.017). No relationship was found between ORR and mRNA expression of aromatase or oestrogen receptors beta (ER-beta).

Conclusion: Neoadjuvant exemestane provided satisfactory efficacy and safety profiles in LA breast cancer. The main biological effects consisted of a reduction in PgR expression for responders and a decrease in Ki-67 expression.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Androstadienes / therapeutic use*
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / metabolism
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery
  • Estrogen Receptor alpha / biosynthesis
  • Estrogen Receptor alpha / genetics
  • Estrogen Receptor beta / biosynthesis
  • Estrogen Receptor beta / genetics
  • Female
  • Humans
  • Immunohistochemistry
  • Ki-67 Antigen / biosynthesis
  • Ki-67 Antigen / genetics
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Postmenopause
  • RNA, Messenger / biosynthesis
  • RNA, Messenger / genetics
  • Receptor, ErbB-2 / biosynthesis
  • Receptor, ErbB-2 / genetics
  • Receptors, Progesterone / biosynthesis
  • Receptors, Progesterone / genetics
  • Reverse Transcriptase Polymerase Chain Reaction

Substances

  • Androstadienes
  • Antineoplastic Agents, Hormonal
  • Estrogen Receptor alpha
  • Estrogen Receptor beta
  • Ki-67 Antigen
  • RNA, Messenger
  • Receptors, Progesterone
  • Receptor, ErbB-2
  • exemestane