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Fulvestrant Is Effective for Patients Failing Other Hormonal Therapy

Fulvestrant Is Effective for Patients Failing Other Hormonal Therapy

BERN, Switzerland—The antiestrogen fulvestrant (Faslodex) is an effective
and well-tolerated treatment option for women with heavily pretreated,
hormone-sensitive advanced breast cancer, according to an interim analysis from
an ongoing study by the Swiss Group for Clinical Cancer Research (SAKK), based
in Bern, Switzerland. All of the patients in the study had failed both
tamoxifen and an aromatase inhibitor, but 11 of 32 patients (34%) had prolonged
clinical benefit on fulvestrant 250 mg every 28 days.

"As third-line therapy, we still see response or stabilization of the
disease in about one-third of patients in this cohort," said Dr. Lucien Perey,
a medical oncologist and investigator with SAKK. "It is a very well tolerated
drug, with very few side effects—mostly hot flashes and some reaction at the
injection site."

Fulvestrant, which has a strong binding affinity for the estrogen receptor
without any associated agonist activity, has been shown to have activity
comparable to the aromatase inhibitor anastrozole (Arimidex) in postmenopausal
women with advanced breast cancer who are progressing on endocrine therapy
(Howell A, et al: J Clin Oncol 20: 3396-3403, 2002). In a previously
reported study, fulvestrant demonstrated a clinical benefit of 69%, with median
response duration of 25 months, in postmenopausal women with tamoxifen-resistant
advanced breast cancer (Howell A, et al: Br J Cancer 74: 300-8, 1996).

The SAKK group sought to assess the efficacy of fulvestrant as third-line
treatment in patients who progress after both tamoxifen and aromatase
inhibitors.

Phase II Multicenter Study

The phase II multicenter study included 36 postmenopausal women (age range
39 to 86 years) with hormone-sensitive advanced breast cancer. All had received
one prior aromatase inhibitor (steroidal and nonsteroidal) and tamoxifen, and
had either progressed or had not responded to treatment.

Response data are available for 32 patients; 4 patients were not eligible
due to protocol violations. Among the 32 evaluable patients, 2 patients (6%)
had a partial response and 9 patients (28%) had stable disease for more than 24
weeks, according to Dr. Perey.

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