Efficacy and safety of low-dose everolimus combined with endocrine drugs for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer

Abstract

Background: To analyze the efficacy and safety of everolimus 5 mg/day in combination with endocrine drugs in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)negative metastatic breast cancer using real-world clinical data.Methods: Clinical data of hormone receptor (HR)-positive and HER2-negative patients with advanced breast cancer treated with everolimus combined with endocrine drugs in our center between August 2012 and May 2017 were retrospectively analyzed. Curative effect and adverse reactions were evaluated.Results: A total of 110 patients were enrolled in this study, and 87.3% received salvage chemotherapy.The median number of salvage treatment lines was 5 (range: 1-19). The median follow-up duration was 12 months (range: 1-56.3 months), the overall response rate (ORR) was 6.4%, the clinical benefit rate (CBR) was 31.8%, the median progression-free survival (mPFS) was 4.0 months (95% CI: 2.9-5.1 months), and the median overall survival (OS) was 17 months (95% CI: 12.1-21.9 months). The mPFS for patients who received ≤2 treatment line was 11.8 months (95% CI: 4.3-19.3 months). Univariate and multivariate analyses suggested that absence of liver metastases, secondary endocrine resistance, and number of metastasis sites <3 were the main factors influencing the benefit of everolimus combined with endocrine therapy. The most common adverse events of grade 3 were: stomatitis (5.5%), non-infectious pneumonia (1.8%), and erythra (1.8%). No grade 4 adverse reactions were observed.Conclusions: Our results showed that everolimus (5 mg/day) combined with endocrine therapy was effective and relatively safe for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

BOLERO-5: a phase II study of everolimus and exemestane combination in Chinese post-menopausal women with ER + /HER2- advanced breast cancer

“…The BOLERO-2 Asian subgroup analysis case retrieval strategy included hyperglycemia, diabetes mellitus, blood glucose increased, glycosuria, type 2 diabetes mellitus, and glucose urine present under the AESI of hyperglycemia/new onset diabetes mellitus, while the BOLERO-5 case retrieval strategy included hyperglycemia, diabetes mellitus, blood glucose increased, diabetic ketosis, glucose tolerance impaired, and glycosylated hemoglobin increased [ 26 ]. Of note, starting treatment with EVE at 5 mg/day rather than 10 mg/day may increase treatment compliance due to good tolerability and similar effectiveness [ 31 ].…”

Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer: a long-term safety and overall survival update from the randomised, double-blind, placebo-controlled, phase 3 trial

“…Nevertheless, the ACE study represents a clear step forward in the development of HDAC inhibitors as epigenetic therapy in advanced HR + /HER2 − breast cancer ( 10 ). Meanwhile, ongoing efforts have been taken on the potential identification of reliable biomarkers, as well as the best treatment plans or sequencing (e.g., post CDK4/6 inhibitor therapy), to select patients who could benefit most from the tucidinostat combination regimens in advanced HR + breast cancer ( 11 ).…”