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FACT: Addition of fulvestrant to anastrozole showed no advantage for breast cancer
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Adding the ER antagonist fulvestrant to anastrozole provided no benefit to women with hormone-receptor-positive breast cancer, according to first results from the Fulvestrant and Anastrozole in Combination Trial (FACT).
Jonas Bergh, MD, PhD, professor of oncology at the Karolinska Institute in Stockholm, Sweden, presented findings from this phase-3 trial.
“Despite favorable preconditions and with mature study data without an interim analysis, time to progression and OS were almost identical between the two therapy arms,” Bergh said during the presentation. “We cannot recommend this type of therapy for further use.”
Researchers investigated the combination of fulvestrant (Faslodex, AstraZeneca) plus anastrozole vs. anastrozole alone at first relapse in hormone-receptor-positive breast cancer.
They randomly assigned postmenopausal or premenopausal women receiving a gonadotropin-releasing hormone agonist to fulvestrant loading dose 500 mg on day zero, 250 mg on day 14 and 28 and 250 mg monthly thereafter plus anastrozole 1 mg daily (n=258) or to anastrozole 1 mg daily alone (n=256). The primary endpoint was time to progression.
The disease progression rates were similar between groups with 77.5% progressing in the combination group and 78.1% progressing in the anastrozole alone group (HR=0.99; 95% CI, 0.81-1.20).
The objective response rate was also similar between the combination group and anastrozole alone group (31.8% vs. 33.6%; OR=0.92; 95% CI, 0.54-1.58). The clinical benefit rate was 55% for patients treated with combination therapy and 55.1% for patients treated with anastrozole alone.
Both treatments were well-tolerated and had similar reports of adverse events, according to researchers.
For more information:
- Bergh J. #23.