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Exemestane May Help Downgrade Tumours Scheduled for Mastectomy to Breast-Conserving Surgery: Presented at EBCC

By Paula Moyer

NICE, FRANCE -- March 27, 2006 -- The aromatase inhibitor exemestane (Aromasin(R)) could make breast-conserving surgery possible in breast cancer patients with large hormone receptor-positive tumours who are scheduled for mastectomy, according to research presented here at the 5^th European Breast Cancer Conference (EBCC).

The findings show that neoadjuvant treatment with exemestane could shrink tumours in these patients, said principal investigator Hidefumi Takei, MD, consultant medical oncologist, division of breast surgery, Saitama Cancer Center, Saitama, Japan.

In his presentation on March 23^rd, Dr. Takei said his team was interested in exemestane's potential because earlier research had shown that other aromatase inhibitors could be used in the neoadjuvant setting for the purpose of shrinking the volume of operable tumours.

In the multicentre, phase 2 Saitama Breast Cancer Clinical Study Group (SBCCSG) 03 trial, Dr. Takei and colleagues evaluated the efficacy and tolerability of neoadjuvant exemestane in 44 postmenopausal women with oestrogen receptor-positive tumours.

Patients had tumours that were 3 cm or larger and were stage II to IIIB. Median patient age was 60 years (range 48 to 88 years).

The study defined pathological response as grade 1b, 2, or 3, and clinical response was determined as being complete or partial by caliper, mammography, or ultrasound.

Twenty-six patients had tumours that were stage IIA and 8 had stage IIB tumours. Of the remaining 10 patients, 4 had stage IIIA tumours and 6 had stage IIIB disease. Within this group, 32 had tumours that were positive for both oestrogen and progesterone receptors, and the remaining 12 were positive for oestrogen receptors and negative for progesterone receptors.

All patients received 25 mg of exemestane daily for 4 months before surgery. In this group, 3 patients discontinued treatment due to adverse events, 1 each experienced a grade 3 haematological disorder, grade 2 dizziness, and grade 1 vaginal bleeding, respectively.

Among the 41 treated patients, there were no complete responses, and 27 had a partial response, for an overall clinical response rate of 66%. Among the remaining patients, 22% had stable disease and 12% had progressive disease.

Three patients went on to undergo chemotherapy due to disease progression. Eight patients refused surgery due to either a partial response or stable disease after treatment and continued on exemestane.

In the 30 patients who had surgery but did not have chemotherapy, 93% were able to have breast-conserving surgery. Within the cohort of 30 patients, 43% had a pathological response.

The investigators observed a response of grade 1b in 9 patients and grade 2 in 4 patients.

Aromasin is manufactured by Pfizer.


[Presentation: Multicenter Phase II Trial of Neoadjuvant Exemestane for Postmenopausal Patients With Hormone-Sensitive, Operable Breast Cancer: Saitama Breast Cancer Clinical Study Group (SBCCSG-03). Abstract 386]

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