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Fulvestrant May Be Effective After Endocrine Treatment Failure in Advanced Breast Cancer: Presented at SABCS

By Charlene Laino

SAN ANTONIO, TX -- December 12, 2002 -- Fulvestrant may be effective in the treatment of postmenopausal women with advanced breast cancer that progresses despite intervention with aromatase inhibitor therapy, preliminary results of a new study suggest.

In a phase II, open-label, multicentre, noncomparative study of postmenopausal women with advanced breast cancer that did not respond to endocrine treatment, a clinical benefit was observed in 34 percent of eligible patients treated with fulvestrant, reported Lucien Perey, MD, of the Centre Pluridisciplinaire d'Oncologie in Lausanne, Switzerland.

Dr. Perey presented the data here on behalf of the Swiss Group for Clinical Cancer Research (SAKK) on December 11^th at a poster session during the 25^th Annual San Antonio Breast Cancer Symposium.

Fulvestrant (Faslodex®, AstraZeneca) is a member of a new class of oestrogen receptor antagonists that downregulate the oestrogen receptor and, unlike tamoxifen, have no known agonist effects. In studies of postmenopausal women with advanced breast cancer progressing on prior endocrine therapy, the drug has shown activity similar to that seen with the aromatase inhibitor anastrozole, Dr. Perey said.

The ongoing SAKK trial is designed to assess the efficacy of fulvestrant as third-line therapy in patients progressing after treatment with tamoxifen and aromatase inhibitors. At the Symposium, Dr. Perey reported on the first 36 patients treated for at least six months. The majority of patients (25 of 36) had bone metastases. Ten patients had liver metastases, nine had skin metastases and 14 had lymph node metastases.

Twenty-one patients received prior chemotherapy, 24 had prior hormonal therapy other than aromatase inhibitors for metastatic disease and 28 women had prior aromatase inhibitor treatment for metastatic disease.

Patients received 250 mg of fulvestrant as a single 5 mL intramuscular injection on day 1, and then every 28 days until objective evidence of disease progression or withdrawal from the trial.

In this heavily pretreated population, two patients showed a partial response and nine patients had stable disease for 24 weeks, which represents 34 percent of eligible patients, Dr. Perey said. Four patients were ineligible, and 21 showed a progression of their disease.

Fulvestrant was well tolerated: Only grade 1 and grade 2 side effects were seen, including fatigue in six patients, loss of appetite in four patients, nausea and vomiting in four and hot flashes in seven women.

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