Aims. To investigate the efficacy of letrozole 2.5 mg and 10 mg used as pri
mary neoadjuvant therapy for patients with locally advanced and large opera
ble breast cancer.
Patients and Methods. Twenty-four postmenopausal patients with locally adva
nced or large operable breast cancer were treated in two consecutive series
with letrozole 2.5 mg (n = 12) or letrozole 10 mg (n = 12). Response at th
ree months was measured by change in tumor volume according to WHO criteria
(partial response was defined as a reduction in tumor volume greater than
or equal to 65%). Tumor volumes were assessed clinically, by ultrasound and
mammography, and pathologically.
Results. All 24 patients were estrogen receptor-positive, were considered '
receptor-rich', and mean age was 77.6 years and 71.6 years in the letrozole
2.5 mg and 10 mg treatment groups, respectively. There were five complete
clinical responses and seven partial clinical responses in the patients tre
ated with 2.5 mg letrozole, and nine partial responses and three patients w
ith stable disease in patients treated with 10 mg letrozole. Assessed by ul
trasound and mammography, the 12 patients treated with 2.5 mg had one compl
ete response, nine partial responses and two with no change. In the 12 pati
ents treated with 10 mg letrozole, imaging gave eight partial responses and
four with no change. One patient treated with the 2.5 mg dose had a comple
te clinical and pathological response. There was no significant difference
between the two doses in effect on tumor volume, and no recordable side eff
ects associated with either dose.
Conclusion. Letrozole used in a neoadjuvant setting is highly effective, pr
oducing clinically beneficial reductions in tumor volume allowing all patie
nts to have breast conserving surgery, and has an acceptable safety profile
.