Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network

This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (A/MBC) who received palbociclib plus an aromatase inhibitor as...

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Published in:Current oncology (Toronto) Vol. 29; no. 2; pp. 1047 - 1061
Main Authors: Law, Jeanna Wallenta, Mitra, Debanjali, Kaplan, Henry G, Alfred, Tamuno, Brufsky, Adam M, Emir, Birol, McCracken, Haley, Liu, Xianchen, Broome, Ronda G, Zhang, Chenan, DiCristo, Caroline, Chen, Connie
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Published: Switzerland MDPI 12-02-2022
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Abstract This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (A/MBC) who received palbociclib plus an aromatase inhibitor as first-line therapy in US community health systems. Using electronic health records from the Syapse Learning Health Network, 242 patients were identified as having received first-line palbociclib plus an aromatase inhibitor between 3 February 2015, and 31 July 2019 (data cutoff 1 February 2020) resulting in a minimum potential 6-month follow-up period. In total, 56.6% of patients had de novo A/MBC at initial breast cancer diagnosis, 50.8% had bone-only disease, and 32.2% had visceral disease. Median follow-up was 22.4 months. Disease progression (26.4%) and intolerance/toxicity (14.9%) were the main reasons for treatment discontinuation. The median (95% CI) real-world progression-free survival was 31.7 (27.9-not estimable (NE)) months and 2-year estimated overall survival (OS) rate was 78.0%. In total, 25.6% of patients died; however, OS data are limited by the small population size and insufficient follow-up time. These real-world effectiveness outcomes complement findings from other real-world studies and randomized controlled trials and support palbociclib plus an aromatase inhibitor as first-line therapy for HR+/HER2- A/MBC.
AbstractList This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor—positive/human epidermal growth factor receptor 2—negative (HR+/HER2−) advanced/metastatic breast cancer (A/MBC) who received palbociclib plus an aromatase inhibitor as first-line therapy in US community health systems. Using electronic health records from the Syapse Learning Health Network, 242 patients were identified as having received first-line palbociclib plus an aromatase inhibitor between 3 February 2015, and 31 July 2019 (data cutoff 1 February 2020) resulting in a minimum potential 6-month follow-up period. In total, 56.6% of patients had de novo A/MBC at initial breast cancer diagnosis, 50.8% had bone-only disease, and 32.2% had visceral disease. Median follow-up was 22.4 months. Disease progression (26.4%) and intolerance/toxicity (14.9%) were the main reasons for treatment discontinuation. The median (95% CI) real-world progression-free survival was 31.7 (27.9—not estimable (NE)) months and 2-year estimated overall survival (OS) rate was 78.0%. In total, 25.6% of patients died; however, OS data are limited by the small population size and insufficient follow-up time. These real-world effectiveness outcomes complement findings from other real-world studies and randomized controlled trials and support palbociclib plus an aromatase inhibitor as first-line therapy for HR+/HER2− A/MBC.
This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (A/MBC) who received palbociclib plus an aromatase inhibitor as first-line therapy in US community health systems. Using electronic health records from the Syapse Learning Health Network, 242 patients were identified as having received first-line palbociclib plus an aromatase inhibitor between 3 February 2015, and 31 July 2019 (data cutoff 1 February 2020) resulting in a minimum potential 6-month follow-up period. In total, 56.6% of patients had de novo A/MBC at initial breast cancer diagnosis, 50.8% had bone-only disease, and 32.2% had visceral disease. Median follow-up was 22.4 months. Disease progression (26.4%) and intolerance/toxicity (14.9%) were the main reasons for treatment discontinuation. The median (95% CI) real-world progression-free survival was 31.7 (27.9-not estimable (NE)) months and 2-year estimated overall survival (OS) rate was 78.0%. In total, 25.6% of patients died; however, OS data are limited by the small population size and insufficient follow-up time. These real-world effectiveness outcomes complement findings from other real-world studies and randomized controlled trials and support palbociclib plus an aromatase inhibitor as first-line therapy for HR+/HER2- A/MBC.
Author Emir, Birol
McCracken, Haley
Liu, Xianchen
DiCristo, Caroline
Alfred, Tamuno
Mitra, Debanjali
Zhang, Chenan
Law, Jeanna Wallenta
Brufsky, Adam M
Broome, Ronda G
Chen, Connie
Kaplan, Henry G
AuthorAffiliation 3 Swedish Cancer Institute, Seattle, WA 98104, USA; hank.kaplan@swedish.org
2 Pfizer Inc., New York, NY 10017, USA; debanjali.mitra@pfizer.com (D.M.); tamuno.alfred@pfizer.com (T.A.); birol.emir@pfizer.com (B.E.); jasonxc.liu@pfizer.com (X.L.); caroline.dicristo@pfizer.com (C.D.); connie.chen@pfizer.com (C.C.)
4 Comprehensive Breast Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA; brufskyam@upmc.edu
1 Syapse, San Francisco, CA 94107, USA; haley.huston@syapse.com (H.M.); ronda.broome@syapse.com (R.G.B.); chenan.zhang@syapse.com (C.Z.)
AuthorAffiliation_xml – name: 4 Comprehensive Breast Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA; brufskyam@upmc.edu
– name: 3 Swedish Cancer Institute, Seattle, WA 98104, USA; hank.kaplan@swedish.org
– name: 1 Syapse, San Francisco, CA 94107, USA; haley.huston@syapse.com (H.M.); ronda.broome@syapse.com (R.G.B.); chenan.zhang@syapse.com (C.Z.)
– name: 2 Pfizer Inc., New York, NY 10017, USA; debanjali.mitra@pfizer.com (D.M.); tamuno.alfred@pfizer.com (T.A.); birol.emir@pfizer.com (B.E.); jasonxc.liu@pfizer.com (X.L.); caroline.dicristo@pfizer.com (C.D.); connie.chen@pfizer.com (C.C.)
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Keywords real-world data
palbociclib
HR+/HER2
metastatic breast cancer
aromatase inhibitor
Language English
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Snippet This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor-positive/human epidermal...
This retrospective single-arm study assessed real-world treatment patterns and clinical outcomes in patients with hormone receptor—positive/human epidermal...
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SubjectTerms Antineoplastic Combined Chemotherapy Protocols
aromatase inhibitor
Aromatase Inhibitors - therapeutic use
Breast Neoplasms - pathology
Female
HR+/HER2
Humans
metastatic breast cancer
palbociclib
Piperazines
Pyridines
real-world data
Receptors, Estrogen - metabolism
Retrospective Studies
Treatment Outcome
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Title Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network
URI https://www.ncbi.nlm.nih.gov/pubmed/35200588
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Volume 29
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