Everolimus in Metastatic Breast Cancer: Clinical Experience as a Late Treatment Line

Abstract

Background: Everolimus (Afinitor®) plus exemestane are indicated for hormone receptor-positive, HER2/neu-negative metastatic breast cancer (MBC), in menopausal women without symptomatic visceral disease after recurrence or progression following aromatase inhibitors. But everolimus efficacy as late treatment has not been explored. Methods: Sixty-three MBC patients progressing under hormonotherapy (HT; n = 30) or after chemotherapy (CT; n = 32) received everolimus plus HT (EHT) and were analyzed for safety, efficacy and overall survival (OS). This cohort was compared with our previous 530 MBC patients stratified by line (PMID 21852136). Results: The median duration of EHT was 27.8 weeks at 5-10 mg/day until clinical progression or toxicity. Median OS was not reached (median follow-up 18 months). Twelve-month survival was 100, 79 and 49% for patients treated with 0 (n = 13), 1-2 (n = 18) and >3 CT (n = 32), respectively. Median time-to-treatment failure was 6.4 months. In 62 EHT patients randomly matched 1:7 with 421 previous patients for age and number of CT, OS improved compared with patients receiving a new CT (p = 0.062). In patients pretreated with <2 CT, EHT gave a better OS than in those with a new CT (p = 0.026). Conclusions: These results may support the use of EHT whatever the number of previous lines.

Clinical Predictive Factors for the Efficacy of Everolimus in Patients With Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer: A Multicenter Retrospective Cohort Study in Japan

“…In this study, the median TTF in unelected patients was 5.2 months, which is similar to that reported in previous real-world cohort studies (4.0-5.7 months). 13–15 The shorter treatment duration compared to that in the BOLERO-2 trial can be attributed to the high proportion of heavily treated patients in our study (ie, 14.2% of patients had PS 2 or 3 and 53.7% of patients had more than 4 previous treatments of EVE). The reason why EVE was administered to more than half of the patients with the later treatment line was that EVE was used immediately after being approved to the later line patients who had been waiting for this drug in this cohort.…”

“…One of the interesting results is that in the multivariate analysis, dose reduction from any initial dose of EVE was associated with a longer TTF. Pouget et al 13 also showed that patients with dose adaptation tended to have a longer TTF in their cohort study. The reason by which dose reduction is correlated with a longer TTF is uncertain.…”

New oral targeted therapies for metastatic breast cancer disrupt the traditional patients’ management-A healthcare providers’ view

“…There is an increasing number of patients under treatment, for increasingly longer periods (Ferlay et al, 2013). However, current treatments for metastatic breast cancer seldom lead to patients' recovery (French NCI, 2014;Pouget et al, 2015). They usually have the effect of delaying the progression of cancer, reducing symptoms and improving the patients' quality of life (Maher, 2014;Piccart et al, 2014).…”