Real-World Outcomes of Everolimus and Exemestane for the Treatment of Metastatic Hormone Receptor-Positive Breast Cancer in Patients Previously Treated With CDK4/6 Inhibitors |
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| Affiliation: | 1. Department of Pharmacy, Cleveland Clinic, Cleveland, OH;2. Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;3. Department of Medical Oncology, University Hospitals Seidman, Cancer Center, Cleveland, OH;4. Department of Quantitative Health Sciences, Cleveland Clinic Lerner Research Institute, Cleveland, OH;1. Penn State Health Milton S Hershey Medical Center, Hershey, PA;2. Penn State College of Medicine, Hershey, PA;1. Department of Surgery, Mayo Clinic, Phoenix, AZ;2. Mayo Clinic Alix School of Medicine, Scottsdale, AZ;3. Department of Research, Mayo Clinic, Phoenix, AZ;4. Division of Surgical Oncology & Endocrine Surgery, Mayo Clinic, Phoenix, AZ;5. Division of Hematology/Oncology, Mayo Clinic, Phoenix, AZ;6. Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, AZ;1. Department of Gynaecology and Obstetrics, Faculty of Medicine, Federal University of Goiás, Goiânia, Brazil;2. Department of Gynaecology and Obstetrics, Faculty of Medicine, Federal University of São Paulo, São Paulo, Brazil;3. Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia, Brazil;4. Discipline of Oncology, Department of Radiology and Oncology, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil;5. Laboratory of Molecular Genetics, Center for Translational Research in Oncology (LIM24), Cancer Institute of Sao Paulo, Sao Paulo, Brazil;1. Department of Breast Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China;3. The First Clinical College, Zhejiang Chinese Medical University, Hangzhou, 310053, China;1. Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI;2. Department of Surgery, Division of Surgical Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI;1. Department of Breast Imaging;2. Department of Breast Surgical Oncology;3. Department of Biostatistics;4. Department of Anatomical Pathology;5. Department of Abdominal Imaging;6. Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX |
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| Abstract: | ![]()
PurposeEverolimus with exemestane (EVE+EXE) was FDA-approved to treat metastatic hormone receptor-positive breast cancer (mHRBC) based on BOLERO-2. However, none of those patients received prior CDK4/6 inhibitors. The purpose of this study is to evaluate the efficacy of EVE+EXE in mHRBC after CDK4/6 inhibitors.MethodsA retrospective review of patients ≥18 years old with mHRBC treated with EVE+EXE, for ≥30 days, at our institution from January 1, 2012, to April 1, 2020 was conducted. Primary objective was to compare progression free survival (PFS) for EVE+EXE between patients with and without prior exposure to CDK4/6 inhibitors. Secondary outcomes included overall survival and safety.Results192 patients were included in the study (n = 79, prior CDK4/6 inhibitor use; n = 113, no prior CDK4/6 inhibitor use). Baseline patient characteristics were similar between groups. Greater number of prior therapies before EVE+EXE use increased risk of disease progression (P = .017). Patients with prior CDK4/6 inhibitor use had a lower median PFS of 3.8 months (95% CI: 3.4-4.7) vs. 5.4 months (95% CI: 3.9-6.2) for patients without prior CDK4/6 inhibitor use, with a HR for progression of 1.46 (95% CI: 1.08 to 1.97, P = .013). Overall survival between groups was not significantly different.ConclusionPatients who received a prior CDK4/6 inhibitor had a lower median PFS benefit from EVE+EXE compared to those who did not, without differences in overall survival. Although PFS is expected to decrease with subsequent lines of therapy, it is reasonable to use EVE+EXE after CDK4/6 inhibitors in selected patients, recognizing that additional benefit is modest. |
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