Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review
AimSince 2021, additional real-world evidence (RWE) has emerged on the effectiveness of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as first-line treatment of HR-positive/HER2-negative (HR+/HER2−) advanced/metastatic breast cancer (A/MBC), necessitating this updated review.MethodsMEDLINE®, Emba...
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-03-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2025.1530391/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850252842788454400 |
|---|---|
| author | Nadia Harbeck Adam Brufsky Chloe Grace Rose Beata Korytowsky Connie Chen Krista Tantakoun Endri Jazexhi Do Hoang Vien Nguyen Meaghan Bartlett Imtiaz A. Samjoo Timothy Pluard |
| author_facet | Nadia Harbeck Adam Brufsky Chloe Grace Rose Beata Korytowsky Connie Chen Krista Tantakoun Endri Jazexhi Do Hoang Vien Nguyen Meaghan Bartlett Imtiaz A. Samjoo Timothy Pluard |
| author_sort | Nadia Harbeck |
| collection | DOAJ |
| description | AimSince 2021, additional real-world evidence (RWE) has emerged on the effectiveness of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as first-line treatment of HR-positive/HER2-negative (HR+/HER2−) advanced/metastatic breast cancer (A/MBC), necessitating this updated review.MethodsMEDLINE®, Embase®, and Cochrane Databases (07/06/2019–01/09/2024), and key congresses (2020–2024) were searched. Studies reporting first-line CDK4/6i use, over 100 participants, and progression-free survival (PFS) and/or overall survival (OS) data were included.ResultsThis update included 82 unique studies, 42.7% for palbociclib, 7.3% for ribociclib, and 3.7% for abemaciclib; 46.3% assessed multiple CDK4/6i. In studies including multiple CDK4/6is, median PFS was 23.4–31.0 months for palbociclib, 19.8–44.0 for ribociclib, and 14.0–39.5 for abemaciclib. When reached, median OS was 38.0–58.0 months, 40.4–52.0 months, and 34.4 months, respectively. These real-world PFS and OS results were within the range of single-arm and CDK4/6i versus endocrine therapy (ET) studies, where CDK4/6i demonstrated greater benefits than ET alone.ConclusionFirst-line CDK4/6i RWE demonstrates significant clinical benefits in HR+/HER2− A/MBC. These data are important to guide clinical decision-making, as they include patients who are not adequately represented in clinical trials. Studies with longer follow-up are needed to assess long-term benefits of all three CDK4/6i therapies in HR+/HER2− A/MBC. |
| format | Article |
| id | doaj-art-13d5909989ff4263bab059daf2fc8c17 |
| institution | OA Journals |
| issn | 2234-943X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj-art-13d5909989ff4263bab059daf2fc8c172025-08-20T01:57:32ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-03-011510.3389/fonc.2025.15303911530391Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic reviewNadia Harbeck0Adam Brufsky1Chloe Grace Rose2Beata Korytowsky3Connie Chen4Krista Tantakoun5Endri Jazexhi6Do Hoang Vien Nguyen7Meaghan Bartlett8Imtiaz A. Samjoo9Timothy Pluard10Breast Center, Department of Gynecology and Obstetrics and Comprehensive Cancer Center Munich, LMU University Hospital, Munich, GermanyUPMC Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA, United StatesPfizer, Inc., New York, NY, United StatesPfizer, Inc., New York, NY, United StatesPfizer, Inc., New York, NY, United StatesValue & Evidence, EVERSANATM, Burlington, ON, CanadaValue & Evidence, EVERSANATM, Burlington, ON, CanadaValue & Evidence, EVERSANATM, Burlington, ON, CanadaValue & Evidence, EVERSANATM, Burlington, ON, CanadaValue & Evidence, EVERSANATM, Burlington, ON, CanadaHematology and Medical Oncology, St. Luke's Cancer Institute, Kansas City, MO, United StatesAimSince 2021, additional real-world evidence (RWE) has emerged on the effectiveness of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as first-line treatment of HR-positive/HER2-negative (HR+/HER2−) advanced/metastatic breast cancer (A/MBC), necessitating this updated review.MethodsMEDLINE®, Embase®, and Cochrane Databases (07/06/2019–01/09/2024), and key congresses (2020–2024) were searched. Studies reporting first-line CDK4/6i use, over 100 participants, and progression-free survival (PFS) and/or overall survival (OS) data were included.ResultsThis update included 82 unique studies, 42.7% for palbociclib, 7.3% for ribociclib, and 3.7% for abemaciclib; 46.3% assessed multiple CDK4/6i. In studies including multiple CDK4/6is, median PFS was 23.4–31.0 months for palbociclib, 19.8–44.0 for ribociclib, and 14.0–39.5 for abemaciclib. When reached, median OS was 38.0–58.0 months, 40.4–52.0 months, and 34.4 months, respectively. These real-world PFS and OS results were within the range of single-arm and CDK4/6i versus endocrine therapy (ET) studies, where CDK4/6i demonstrated greater benefits than ET alone.ConclusionFirst-line CDK4/6i RWE demonstrates significant clinical benefits in HR+/HER2− A/MBC. These data are important to guide clinical decision-making, as they include patients who are not adequately represented in clinical trials. Studies with longer follow-up are needed to assess long-term benefits of all three CDK4/6i therapies in HR+/HER2− A/MBC.https://www.frontiersin.org/articles/10.3389/fonc.2025.1530391/fullCDK4/6 inhibitorsquality assessmentbreastmetastasisreal-world evidencesystematic literature review |
| spellingShingle | Nadia Harbeck Adam Brufsky Chloe Grace Rose Beata Korytowsky Connie Chen Krista Tantakoun Endri Jazexhi Do Hoang Vien Nguyen Meaghan Bartlett Imtiaz A. Samjoo Timothy Pluard Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review Frontiers in Oncology CDK4/6 inhibitors quality assessment breast metastasis real-world evidence systematic literature review |
| title | Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review |
| title_full | Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review |
| title_fullStr | Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review |
| title_full_unstemmed | Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review |
| title_short | Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review |
| title_sort | real world effectiveness of cdk4 6i in first line treatment of hr her2 advanced metastatic breast cancer updated systematic review |
| topic | CDK4/6 inhibitors quality assessment breast metastasis real-world evidence systematic literature review |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2025.1530391/full |
| work_keys_str_mv | AT nadiaharbeck realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT adambrufsky realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT chloegracerose realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT beatakorytowsky realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT conniechen realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT kristatantakoun realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT endrijazexhi realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT dohoangviennguyen realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT meaghanbartlett realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT imtiazasamjoo realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview AT timothypluard realworldeffectivenessofcdk46iinfirstlinetreatmentofhrher2advancedmetastaticbreastcancerupdatedsystematicreview |