From clinical trials to clinical practice: the use of everolimus and exemestane in the treatment of hormone receptor-positive metastatic breast cancer: real-world data.
Hikmat Abdel-RazeqBaha' SharafHazem AbdulelahNayef Abdel-RazeqMourad SalamBayan InseratRayan BaterPublished in: Journal of chemotherapy (Florence, Italy) (2021)
Everolimus combined with exemestane can modulate endocrine resistance. The combination showed significant improvement in progression-free survival (PFS) in phase III clinical trials for hormone receptor positive metastatic breast cancer patients. It also showed serious adverse events. We evaluate the efficacy and prevalence of serious adverse events in a real-world setting. We retrospectively examined 91 breast cancer patients; all were previously treated with chemotherapy and fulvestrant (84% and 59%, respectively). After a 13-month median follow-up, 29% had a partial response, and 32% had stable disease. The PFS was 7.8 months. Due to adverse events, 19% of patients stopped the treatment, while 31% required a dose reduction. Despite enrolling heavier-pretreated patients, our real-world outcome for the efficacy and safety of the exemestane and everolimus match those of the clinical trials. Such results should assure clinicians and lead to wider adoption of this oral, chemotherapy-sparing regimen.
Keyphrases
- clinical trial
- metastatic breast cancer
- end stage renal disease
- phase iii
- newly diagnosed
- ejection fraction
- chronic kidney disease
- clinical practice
- free survival
- peritoneal dialysis
- prognostic factors
- small cell lung cancer
- squamous cell carcinoma
- open label
- phase ii
- risk factors
- electronic health record
- locally advanced
- patient reported outcomes
- minimally invasive