Is Hormone Therapy + Everolimus Effective for Breast Cancer?
Is Hormone Therapy + Everolimus Effective for Breast Cancer?
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Is Hormone Therapy + Everolimus Effective for Breast Cancer?
On May 23, 2022, Thomas Bachelot and colleagues from Centre Leon Berard published the results of a Phase III clinical trial (NCT01805271) on the efficacy and safety of hormone therapy + Everolimus as adjuvant therapy in high-risk, hormone receptor-positive, HER2-negative primary breast cancer patients in the Journal of Clinical Oncology.
This Phase III clinical trial randomized high-risk, hormone receptor-positive, HER2-negative primary breast cancer patients (N = 1278) into two groups: hormone therapy + Everolimus (continued for 2 years) and hormone therapy + placebo (continued for 2 years). The primary endpoint was progression-free survival.
The trial results showed that for the primary endpoint, the 3-year progression-free survival rate was: hormone therapy + Everolimus group 88% versus hormone therapy + placebo group 89%, showing no significant difference between the two groups. Regarding safety, the incidence of Grade 3 or higher adverse events was: hormone therapy + Everolimus group 29.9% versus hormone therapy + placebo group 15.9%. The rate of treatment discontinuation early in the trial was: hormone therapy + Everolimus group 53.4% versus hormone therapy + placebo group 22.3%.
Based on the Phase III clinical trial results, Thomas Bachelot and colleagues concluded that high-risk, hormone receptor-positive, HER2-negative primary breast cancer patients receiving hormone therapy + Everolimus as adjuvant therapy showed no significant improvement in progression-free survival, and approximately half of patients discontinued Everolimus treatment. They do not recommend Everolimus as adjuvant therapy.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.21.02179
https://ascopubs.org/doi/abs/10.1200/JCO.21.02179
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