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Annals of Oncology Advance Access originally published online on January 15, 2009
Annals of Oncology 2009 20(4):655-659; doi:10.1093/annonc/mdn687
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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

breast cancer

Neo-adjuvant exemestane in elderly patients with breast cancer: a phase II, multicentre, open-label, Italian study

G. Mustacchi1,*, M. Mansutti2, C. Sacco2, S. Barni3, A. Farris4, M. Cazzaniga3, M. Cozzi2 and C. Dellach1

1 Cattedra di Oncologia Medica-Centro Oncologico, Trieste
2 Dipartimento Interaziendale di Oncologia, Udine
3 UO Oncologia Medica, Azienda Ospedaliera, Treviglio
4 Cattedra Oncologia Medica, Università di Sassari, Sassari, Italy

* Correspondence to: Prof. G. Mustacchi, Centro Oncologico, Università di Trieste, Via Pietà 19, 34100 Trieste, Italy. Tel: +39-040-3992232l; Fax: +39-040-7606111; E-mail: g.mustacchi{at}fmc.units.it

Background: The steroidal aromatase inhibitor exemestane has demonstrated efficacy for the treatment of breast cancer in the metastatic and adjuvant settings. Smaller trials have also reported efficacy in the neo-adjuvant setting.

Patients and methods: This phase II, open-label, multicentre study examined the efficacy and safety of neo-adjuvant exemestane in women aged >70 years with operable, receptor-rich breast cancer. Consecutive eligible patients received exemestane 25 mg/day for 6 months before planned surgery. The primary end point was clinical response.

Results: Overall, 117 patients were recruited (median age 80 years). The objective response rate in 112 assessable patients (85 with clinical and mammographic evaluation; 27 with clinical evaluation only) was 69.6% (two complete responses; 76 partial responses). In patients who responded, median tumour size reduced from 4.81 to 2.12 cm. Seventy-seven patients (68.7%) continued to surgery. Of the 40 patients eligible for breast-conserving surgery, 34 (85%) deemed unfit for this procedure at baseline. Exemestane-related adverse events were unremarkable except for grade 3 allergic skin reactions in two patients (1.8%).

Conclusion: Neo-adjuvant exemestane given for 6 months appears to be effective for receptor-rich breast cancer in older patients. There may now be sufficient evidence to support the use of neo-adjuvant in this patient population.

Key words: aromatase inhibitor, breast cancer, endocrine therapy, exemestane, neo-adjuvant

Received for publication May 9, 2008. Revision received September 24, 2008. Accepted for publication September 29, 2008.


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