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Fulvestrant, Exemestane Show Equivalent Survival in Relapsed Aromatase Inhibitor-Treated Breast Cancer: Presented at SABCS

By John Gever

SAN ANTONIO, TX -- December 16, 2007 -- Breast cancer patients who relapse on aromatase inhibitor therapy survive as long with fulvestrant as with exemestane, according to new data from the phase 3 Evaluation of Fulvestrant versus Exemestane Clinical Trial (EFECT).

The results were presented here on December 14 at the 30th Annual San Antonio Breast Cancer Symposium (SABCS) by Stephen Chia, MD, Senior Scientist, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.

Median overall survival rates were similar with the two treatments; 23.1 months for exemestane and 24.3 months for fulvestrant (hazard ratio [HR] 1.012; 95% confidence interval [CI]: 0.833-1.229 favoring exemestane).

These are the first survival data reported from the closely watched EFECT. The trial is a randomized, double-blind, placebo-controlled trial in 693 postmenopausal women with hormone-receptor-positive breast cancer who had disease progression or recurrence while taking a nonsteroidal aromatase inhibitor such as anastrozole or letrozole.

Patients in the fulvestrant arm received an initial intramuscular loading dose of 500 mg followed by injections of 250 mg on study days 14 and 28 and every 4 weeks thereafter. Exemestane was given orally at 25 mg/day.

Median follow-up in the most recent data analysis was 20.9 months, with some patients followed for more than 43 months.

The researchers said no survival differences have emerged between treatments in subgroups defined by hormone receptor status. Median overall survival was about 24 months with both treatments in patients who were positive or negative for estrogen receptors (ER) and progesterone receptors (PgR), according to the researchers.

The two treatments were well tolerated. The most common treatment-related adverse effects were similar between groups, the researchers said. However, rates of hot flashes, fatigue, and pain in joints and extremities were more common by at least 2% with exemestane.

Other common adverse effects included injection-site pain, nausea, myalgia, diarrhea, and asthenia.

Data on progression-free survival were released a year ago, with median follow-up of 13 months. At that time, progression rates were similar: 87.4% with exemestane and 82.1% with fulvestrant, with median time to progression of 3.7 months in both arms.

Despite the relatively short progression-free and overall survival times, the researchers said that "fulvestrant and exemestane are valid treatment options for the control of advanced breast cancer after nonsteroidal aromatase inhibitor therapy."

Funding for the EFECT study was provided by AstraZeneca, which markets fulvestrant under the trade name Faslodex.


[Presentation title: Fulvestrant vs Exemestane Following Non-Steroidal Aromatase Inhibitor Failure: First Overall Survival Data From the EFECT trial. Abstract 2091]

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