High-Dose Fulvestrant Postpones Disease Progression in Advanced Breast Cancer: Presented at SABCS

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Janette
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High-Dose Fulvestrant Postpones Disease Progression in Advanced Breast Cancer: Presented at SABCS

Postby Janette » Sat Dec 19, 2009 11:12 am

By Jill Stein

SAN ANTONIO, Tex -- December 11, 2009 -- Increasing the dose of fulvestrant from the approved 250-mg dose to 500 mg reduces the risk of disease progression by 20% in postmenopausal women with oestrogen receptor (ER)-positive advanced breast cancer without increasing toxicity, according to a study presented here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS).

For the multicentre, phase 3 Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) study, Angelo DiLeo, MD, Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Prato, Italy, and colleagues randomised 736 women to receiving either fulvestrant 500 mg or fulvestrant 250 mg.

"If a patient has aggressive disease and is expected to progress in 4 months, the 20% reduction in disease progression that occurs with fulvestrant 500 mg means that the patient will gain roughly 1 month," said Dr. DiLeo on December 10. "But if the patient has slow-growing disease that is going to progress in about 1.5 years, the 20% reduction means that the patient will gain about 4 months. So treatment benefit depends on the biology of the disease."

All women were postmenopausal with oestrogen receptor-positive advanced breast cancer that had recurred or progressed after prior endocrine therapy.

The 500-mg dose was administered as two 250-mg intramuscular injections on day 0, 14, and 28 and then 500 mg once every 28 days thereafter.

Treatment with fulvestrant continued until disease progression, or discontinuation for any other reason. Patients were assessed for tumour progression every 12 weeks.

The primary efficacy endpoint was the time to progression (TTP).

The study found that the TTP was 6.5 months in the high-dose fulvestrant group versus 5.5 months in the low-dose fulvestrant group (P = .006), for a 20% reduction in risk of progression.

The analysis also showed a nonsignificant 16% reduction in the risk of death in the high-dose compared with the low-dose fulvestrant group.

Fulvestrant 500 mg was well tolerated, with a safety profile in line with that of fulvestrant 250 mg and no evidence of dose-dependence for any adverse event.

Dr. DiLeo said that the TTP improvement seems to be a consequence of an increase in the rate, and of a prolongation in duration, of disease stabilisation.

Funding for this study was provided by AstraZeneca Pharmaceuticals.
Janette


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