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Everolimus plus hormone therapy had clinical benefit in aromatase inhibitor-resistant metastatic breast cancer
Everolimus in combination with tamoxifen is a safe and effective treatment for women with aromatase inhibitor-resistant metastatic breast cancer, according to results of the phase-2 GINECO study.
The results suggest “tamoxifen combined with everolimus may reverse hormone resistance and lead to increased clinical benefit rate, time to progression and OS compared with tamoxifen alone in postmenopausal women with aromatase inhibitor-resistant metastatic breast cancer,” the researchers concluded.
In the study, researchers randomly assigned postmenopausal women to treatment with tamoxifen plus everolimus (n=54) or tamoxifen alone (n=57). All women were hormone receptor-positive, HER-2–negative and aromatase inhibitor-resistant. The primary endpoint was clinical benefit rate, which was a composite of any patient with a complete response or partial response or stable disease at 6 months.
Source: Bachelot T. J Clin Oncol. 2012;doi:10.1200/JCO.2011.39.0708.
At 6 months, 61% of women in the intent to treat population assigned to the combination had clinical benefit, compared with 42% of women assigned to tamoxifen alone. Women assigned to the combination also had an increase in time to progression compared with those assigned to tamoxifen alone (8.6 months vs. 4.5 months), which conferred a 46% decreased risk for progression (95% CI, 0.36-0.81). The combination treatment also led to a 55% decreased risk for death (95% CI, 0.24-0.81).
Data also indicated that those women with secondary resistance to aromatase inhibitors had more benefit from the combination treatment than women with primary resistance (see chart).
Adverse effects for both groups were manageable. The primary toxicities in the combination group were fatigue, stomatitis, rash, anorexia and diarrhea.
References:
- Bachelot T. J Clin Oncol. 2012;doi:10.1200/JCO.2011.39.0708.