Exemestane (Exe) as primary treatment in hormonosensible early breast cancer of the elderly: Preliminary results of a phase II multicenter open Italian study

Autor:	C. Dellach, Antonio Farris, Mauro Mansutti, Sandro Barni, Marina Elena Cazzaniga, Cosimo Sacco, R. Ceccherini, Giorgio Mustacchi
Rok vydání:	2006
Předmět:	Gynecology Oncology Cancer Research medicine.medical_specialty Phase iii trials business.industry chemistry.chemical_compound Exemestane chemistry Internal medicine medicine Primary treatment business Tamoxifen Early breast cancer medicine.drug
Zdroj:	Journal of Clinical Oncology. 24:10689-10689
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2006.24.18_suppl.10689
Popis:	10689 Background: In the late 90s two large phase III trials (GRETA & CRC) showed that tamoxifen as sole treatment was a possible alternative to surgery in old women. Two Phase III neoadjuvant trials showed recently that letrozole is superior and anastrozole is not inferior to tamoxifen.A few phase II and a small fase III trials showed interesting results also with the steroidal inactivator exemestane. Methods: We are running a fase II open trial in early breast cancer patients aged over 70 with receptor rich tumors, treated with exemestane 25 mgs/day for 6 months before surgery. Primary endpoints are clinical response, breast conservative surgery (BCS) rate and safety. Results: Of the planned 100 patients we report preliminary results on 50 patients (mean age 81 , range 70–92) evaluable for clinical and mammographic response. 33/50 had a partial response (66%), 2/50 PD on treatment. Clinical basal mean size of tumors was 4.4 cms (4,81 in responders) and 2,67 cms the final in responders patients. Eight patients refused surgery, 12 are too early, 23/30 underwent BCS where 17 of them (74%) were unfit for BCS at basal evaluation. No remarcable exemestane related toxicity was recorded. Conclusions: As expected from published data of phase III trials in metastatic and adjuvant setting, exemestane appears to be very active also in the neoadjuvant setting. Probably there is no more need of large phase III trials in order to consider exemestane in the preoperative setting in rich receptor tumors. In old and frail patients this could also be considered as sole treatment. [Table: see text]
Databáze:	OpenAIRE
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