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Real-World Treatment Patterns and Outcomes of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
Affiliation:1. Texas Oncology-Austin Central, Austin, TX;2. Pfizer Inc, New York, NY;3. The University of Texas MD Anderson Cancer Center, Houston, TX;4. UPMC Hillman Cancer Center, University of Pittsburgh Medical Center, College of Medicine, Pittsburgh, PA;1. Department of Radiation Oncology, Dana-Farber Cancer Institute, Harvard University, Boston, MA;2. Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;3. Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ;4. Department of Surgery, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ;1. The University of Cambridge, The Old Schools, Cambridge, United Kingdom;2. Cambridge University Hospitals, Breast Unit, Cambridge Biomedical Research Centre, Cambridge, United Kingdom;1. Department of Internal Medicine, University Hospitals Leuven, Leuven, Belgium;2. Department of General Medical Oncology/Multidisciplinary Breast Center, University Hospitals Leuven – Campus Gasthuisberg, Leuven, Belgium;3. Surgical Oncology/Multidisciplinary Breast Center, University Hospitals Leuven – Campus Gasthuisberg, Leuven, Belgium;4. Department of Gynaecological Oncology/Multidisciplinary Breast Center, University Hospitals Leuven – Campus Gasthuisberg, Leuven, Belgium;5. Department of Radiotherapy/Multidisciplinary Breast Center, University Hospitals Leuven – Campus Gasthuisberg, Leuven, Belgium;6. Department of Public Health and Primary Care, Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Catholic University Leuven, Leuven, Belgium;1. Department of Bioresources, School of Biological Sciences, University of Kashmir, Srinagar-190006, J&K India;2. Department of Medical Laboratory Sciences, CAMS, Majmaah University, Almajmaah, KSA;3. Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, KSA;4. Department of Translational Medicine, Research Branch, Sidra Medicine, Doha, Qatar;5. Department of Diagnostic Imaging, St. jude Children''s Research Hospital, Memphis, TN;6. Department of Biotechnology, School of Life Sciences, Central University of Kashmir, Ganderbal, J&K, India;1. Cancer Biology Laboratory, Department of Biochemistry and Bioinformatics, GITAM School of Science, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India;2. Department of Bioscience and Biotechnology, Banasthali University, Vanasthali, Rajasthan, India;3. Department of Hematology and Oncology, School of medicine, University of Alabama, Birmingham, Birmingham, AL
Abstract:IntroductionTo describe real-world treatment patterns and effectiveness of first-line palbociclib plus an aromatase inhibitor (PAL+AI) and examine the association between PAL initial dose and effectiveness among patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic/advanced breast cancer (HR+/HER2– MBC) in routine clinical practice.Patients and MethodsThis retrospective analysis used Flatiron Health's database of electronic health records from >280 cancer clinics representing >2.4 million actively treated cancer patients in the United States. Women with HR+/HER2− MBC who received first-line PAL+AI were included. Real-world progression-free survival (rwPFS) was defined as the time from starting PAL+AI to death or disease progression. Real-world best tumor response (rwBTR) was assessed based on the treating clinician's assessment of radiologic evidence for change in disease burden.ResultsOf 813 eligible patients, median age was 65.0 years, and median follow-up was 21.0 months. PAL was initiated at 125 mg/d and 75/100 mg/d in 86.5% and 13.5% of patients, respectively. Median duration of PAL+AI was 16.3 months. 43.0% of patients discontinued PAL+ AI; 11.0% discontinued because of toxicity. Median time to subsequent therapy and chemotherapy was 24.6 and 36.6 months, respectively. Median rwPFS was 20.0 months, and best rwBTR rate was 51.9%. Patients starting PAL at 125 versus 75/100 mg/d had longer median rwPFS (27.8 vs. 18.6 months) and higher rwBTR rate (54.0% vs. 40.4%).ConclusionThese data demonstrate the benefit of PAL+AI in routine clinical practice and may support the initiation of palbociclib at the recommended dose of 125 mg/d for HR+/HER2− MBC.Trial Registration Number and Date of RegistrationNCT04176354, November 25, 2019
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