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Novel steroidal compound has clinical activity in advanced breast cancer
Buzdar A. Cancer. 2011;epub ahead of print.
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TAS-108, a novel steroidal compound that has bone-protective effects, has clinical activity at 40 mg and 80 mg in women with advanced hormone-responsive breast cancer, according to the results of a phase 2 study.
Because other selective ER modulators such as tamoxifen or aromatase inhibitors have known side effects, researchers sought to examine the clinical efficacy and safety profile of TAS-108, a compound with both ER alpha antagonist activity and partial ER beta agonist activity.
In the study, researchers tested three daily doses of TAS-108: 40 mg, 80 mg and 120 mg. They enrolled postmenopausal women with locally advanced, inoperable or metastatic hormone receptor-positive breast cancer.
The study had two stages.
In the first stage, 19 patients were enrolled into each dose group. If at least three patients in that dose group achieved a clinical benefit, further patients could be enrolled.
Clinical benefit was defined as the total number of patients who achieved complete response, partial response or stable disease for 24 weeks or longer.
The 120-mg dose group (n=19) was stopped early due to a lack of response.
In the 40-mg dose group (n=61), 21.7% of patients reported clinical benefit, with 8.3% achieving complete response or partial response and 13.3% achieving stable disease.
In the 80-mg group (n=66), 20% of patients achieved clinical benefit, with 5% achieving partial or complete response and 15% achieving stable disease.
Median time to progression was 15 weeks for the 40-mg group and 15.9 weeks for the 80-mg group.
“On the basis of the acceptable clinical benefit in the current study with no clear dose effect between the tested doses of 40 mg daily and 120 mg daily, the safety profile demonstrating a possible increase in treatment-emergent adverse events with increasing dose, and the TAS-108 pharmacokinetic profile, the 40-mg dose of TAS-108 is an appropriate dose for further testing,” the researchers concluded.
Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.
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