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


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%).


CONCLUSIONS
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.
Mustacchi
G
G
Cattedra di Oncologia Medica-Centro Oncologico, Università di Trieste, Trieste, Italy. g.mustacchi@fmc.units.it
Mansutti
M
M
Sacco
C
C
Barni
S
S
Farris
A
A
Cazzaniga
M
M
Cozzi
M
M
Dellach
C
C
D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D016896:Treatment Outcome
D000730:Androstadienes; D000970:Antineoplastic Agents; C056516:exemestane