Breast Cancer Research and Treatment

, Volume 112, Issue 1, pp 203–213 | Cite as

Exemestane as primary systemic treatment for hormone receptor positive post-menopausal breast cancer patients: a phase II trial of the Austrian Breast and Colorectal Cancer Study Group (ABCSG-17)

  • Brigitte Mlineritsch
  • Christoph Tausch
  • Christian Singer
  • Gero Luschin-Ebengreuth
  • Raimund Jakesz
  • Ferdinand Ploner
  • Michael Stierer
  • Elisabeth Melbinger
  • Christian Menzel
  • Andrea Urbania
  • Michael Fridrik
  • Günther Steger
  • Peter Wohlmuth
  • Michael Gnant
  • Richard Greil
  • on behalf of the Austrian Breast, Colorectal Cancer Study Group (ABCSG)
Clinical Trial

Abstract

Background A multicenter phase II study was conducted to analyze the clinical activity of the steroidal aromatase inhibitor exemestane in the neoadjuvant treatment of post-menopausal women with strongly ER- and/or PgR- positive operable breast cancer. Patients and methods From September 2000 to December 2003, 80 women were recruited for treatment with exemestane 25 mg once daily for 4 months. The primary end-point was the clinical response rate according the WHO criteria; the secondary end-points included toxicity and the number of patients who qualified for breast conserving surgery at the end of treatment, comparability of evaluation methods for response, potential alterations of hormone receptor and Her2/neu status during treatment. Results On an intention to evaluate analysis, according to the prespecified criteria the overall clinical objective response rate was 34%, the pCR rate was 3% and the rate of breast conserving surgery was 76%. When sonographic and mammographic longitudinal measurements were included in patients with missing palpation data, response rates were 38% and 41%, respectively. The tumor response was independent of the Her2/neu status which remained unchanged during treatment. In contrast, while the ER expression remained unaltered, downregulation of the PgR was observed. The treatment was well tolerated with no grade 3 and 4 toxicities except gastrointestinal (one grade 3 case) and hot flushes (two grade 3 cases). Conclusion This study shows that exemestane is effective and safe as a preoperative therapy in post-menopausal patients with strongly hormone receptor-positive breast cancer.

Keywords

Exemestane Neoadjuvant systemic therapy Post-menopausal breast cancer Surgery Her2/neu status 

Notes

Acknowledgements

We thank Karin Wetzlinger for her secretarial assistance, Rajam Csordas-Iyer for helpful comments and Michaela Schachner for her assistance in preparation this article. We also would like to acknowledge Pfizer Austria for their contribution to this study.

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Copyright information

© Springer Science+Business Media, LLC. 2007

Authors and Affiliations

  • Brigitte Mlineritsch
    • 1
  • Christoph Tausch
    • 2
  • Christian Singer
    • 3
  • Gero Luschin-Ebengreuth
    • 4
  • Raimund Jakesz
    • 5
  • Ferdinand Ploner
    • 6
  • Michael Stierer
    • 7
  • Elisabeth Melbinger
    • 8
  • Christian Menzel
    • 9
  • Andrea Urbania
    • 10
  • Michael Fridrik
    • 11
  • Günther Steger
    • 12
  • Peter Wohlmuth
    • 5
  • Michael Gnant
    • 5
  • Richard Greil
    • 1
  • on behalf of the Austrian Breast, Colorectal Cancer Study Group (ABCSG)
    • 13
  1. 1.IIIrd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectious Disease, Laboratory of Immunological and Molecular Cancer ResearchParacelsus Medical University SalzburgSalzburgAustria
  2. 2.Department of SurgeryBHS HospitalLinzAustria
  3. 3.Division of Special Gynaecology, General HospitalMedical University of ViennaViennaAustria
  4. 4.Department of GynaecologyMedical University of GrazGrazAustria
  5. 5.Department of SurgeryMedical University of ViennaViennaAustria
  6. 6.Department of Internal Medicine, Division of OncologyMedical University of GrazGrazAustria
  7. 7.Department of SurgeryHanusch Medical CenterViennaAustria
  8. 8.Department of SurgeryWolfsberg HospitalWolfsbergAustria
  9. 9.Department of Special GynaecologyParacelsus Medical University SalzburgSalzburgAustria
  10. 10.Department of SurgeryKlagenfurt HospitalKlagenfurtAustria
  11. 11.Department of Internal Medicine 3, Center for Hematology and Medical OncologyGeneral Hospital LinzLinzAustria
  12. 12.Department of Oncology, General HospitalMedical University of ViennaViennaAustria
  13. 13.ViennaAustria

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