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 |
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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. |
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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.) |
Author_xml | – sequence: 1 givenname: Jeanna Wallenta surname: Law fullname: Law, Jeanna Wallenta organization: Syapse, San Francisco, CA 94107, USA – sequence: 2 givenname: Debanjali surname: Mitra fullname: Mitra, Debanjali organization: Pfizer Inc., New York, NY 10017, USA – sequence: 3 givenname: Henry G surname: Kaplan fullname: Kaplan, Henry G organization: Swedish Cancer Institute, Seattle, WA 98104, USA – sequence: 4 givenname: Tamuno surname: Alfred fullname: Alfred, Tamuno organization: Pfizer Inc., New York, NY 10017, USA – sequence: 5 givenname: Adam M orcidid: 0000-0001-8080-7960 surname: Brufsky fullname: Brufsky, Adam M organization: Comprehensive Breast Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA – sequence: 6 givenname: Birol surname: Emir fullname: Emir, Birol organization: Pfizer Inc., New York, NY 10017, USA – sequence: 7 givenname: Haley surname: McCracken fullname: McCracken, Haley organization: Syapse, San Francisco, CA 94107, USA – sequence: 8 givenname: Xianchen surname: Liu fullname: Liu, Xianchen organization: Pfizer Inc., New York, NY 10017, USA – sequence: 9 givenname: Ronda G surname: Broome fullname: Broome, Ronda G organization: Syapse, San Francisco, CA 94107, USA – sequence: 10 givenname: Chenan orcidid: 0000-0003-1773-4441 surname: Zhang fullname: Zhang, Chenan organization: Syapse, San Francisco, CA 94107, USA – sequence: 11 givenname: Caroline orcidid: 0000-0002-2317-5976 surname: DiCristo fullname: DiCristo, Caroline organization: Pfizer Inc., New York, NY 10017, USA – sequence: 12 givenname: Connie surname: Chen fullname: Chen, Connie organization: Pfizer Inc., New York, NY 10017, USA |
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Cites_doi | 10.1080/14656566.2017.1351947 10.1001/jama.2018.10136 10.3390/curroncol28030209 10.1002/cncr.25677 10.1158/1078-0432.CCR-15-1185 10.1016/j.ejca.2018.08.011 10.1056/NEJMoa1810527 10.1016/j.breast.2018.10.009 10.1158/1538-7445.AM2020-CT086 10.1002/cnr2.1388 10.1200/CCI.20.00143 10.2217/fon-2020-0744 10.1158/1078-0432.CCR-16-0493 10.1007/s10549-017-4529-5 10.1186/s13058-021-01409-8 10.6004/jnccn.2018.7094 10.1056/NEJMoa1505270 10.1007/s10549-019-05176-1 10.1007/s10549-018-05125-4 10.3322/caac.21708 10.1186/s13058-018-0958-2 10.1007/s10549-020-05755-7 10.1016/S1470-2045(14)71159-3 10.1056/NEJMoa1607303 10.1200/JCO.2021.39.15_suppl.1000 10.1200/JCO.2020.38.15_suppl.9606 10.1016/j.breast.2020.11.008 |
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Keywords | real-world data palbociclib HR+/HER2 metastatic breast cancer aromatase inhibitor |
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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 |
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