Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study
Background and purpose: Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, combined with aromatase inhibitors (AI), can be used in first-line treatment for estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) normal advanced breast cancer (ABC). This study aim...
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Medical Journals Sweden
2025-06-01
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| Series: | Acta Oncologica |
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| Online Access: | https://medicaljournalssweden.se/actaoncologica/article/view/43226 |
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| author | Alan Celik Laurits Sebastian Dahl Rasmus Garly Vesna Glavicic Maja Bendtsen Sharma Sophie Yammeni Humma Khan Daniel Sloth Hauberg Hanne Schultz Kapel Ann Knoop Tobias Berg |
| author_facet | Alan Celik Laurits Sebastian Dahl Rasmus Garly Vesna Glavicic Maja Bendtsen Sharma Sophie Yammeni Humma Khan Daniel Sloth Hauberg Hanne Schultz Kapel Ann Knoop Tobias Berg |
| author_sort | Alan Celik |
| collection | DOAJ |
| description | Background and purpose: Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, combined with aromatase inhibitors (AI), can be used in first-line treatment for estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) normal advanced breast cancer (ABC). This study aims to assess the impact of age and comorbidities on the progression-free survival (PFS) and overall survival (OS) of patients treated with palbociclib and AI.
Materials and methods: This nationwide, retrospective cohort study included 604 women with ER positive, HER2 normal ABC treated with palbociclib and an AI between 2017 and 2021. Data were obtained from the Danish Breast Cancer Group database. Survival outcomes were analyzed based on age, Charlson Comorbidity Index (CCI), number of comorbidities, and comorbidity type. PFS and OS were estimated using the Kaplan–Meier method.
Results: Median PFS for all patients was 30.6 months (95% confidence interval [CI], 27.4–34.2), and median OS was 55.6 months (95% CI, 51.8–58.9). Patients aged 65–75 years had significantly longer PFS and OS (p = 0.031 and p = 0.012) than patients aged under 65 and over 75 years. Visceral metastases were associated with shorter PFS and OS (p = 0.005). Comorbidity burden, including CCI score and comorbidity type, did not significantly affect survival outcomes.
Interpretation: In our data set, univariate analyses suggest age and visceral metastases to be potential factors influencing outcomes in patients with ABC treated with palbociclib plus an AI. Comorbidities, did not significantly impact survival, suggesting that palbociclib is well-tolerated in patients with varying health profiles.
ClinicalTrials.gov ID: NCT06307457.
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| format | Article |
| id | doaj-art-90a7d6851e4b4a218ce24dc5eeff8429 |
| institution | Kabale University |
| issn | 1651-226X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Oncologica |
| spelling | doaj-art-90a7d6851e4b4a218ce24dc5eeff84292025-08-20T03:25:15ZengMedical Journals SwedenActa Oncologica1651-226X2025-06-016410.2340/1651-226X.2025.43226Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective studyAlan Celik0https://orcid.org/0000-0001-9952-6472Laurits Sebastian Dahl1Rasmus Garly2Vesna Glavicic3Maja Bendtsen Sharma4Sophie Yammeni5Humma Khan6Daniel Sloth Hauberg7Hanne Schultz Kapel8Ann Knoop9https://orcid.org/0000-0003-2898-1093Tobias Berg10https://orcid.org/0000-0003-2006-6616Danish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Zealand University Hospital, Emergency Department, Nykoebing F, DenmarkDanish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkDanish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Oncology, Zealand University Hospital, Naestved, DenmarkDepartment of Oncology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Oncology, Aalborg University Hospital, Aalborg, DenmarkPfizer ApS, Ballerup, DenmarkPfizer ApS, Ballerup, DenmarkPfizer ApS, Ballerup, DenmarkDepartment of Clinical Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkDanish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkBackground and purpose: Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, combined with aromatase inhibitors (AI), can be used in first-line treatment for estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) normal advanced breast cancer (ABC). This study aims to assess the impact of age and comorbidities on the progression-free survival (PFS) and overall survival (OS) of patients treated with palbociclib and AI. Materials and methods: This nationwide, retrospective cohort study included 604 women with ER positive, HER2 normal ABC treated with palbociclib and an AI between 2017 and 2021. Data were obtained from the Danish Breast Cancer Group database. Survival outcomes were analyzed based on age, Charlson Comorbidity Index (CCI), number of comorbidities, and comorbidity type. PFS and OS were estimated using the Kaplan–Meier method. Results: Median PFS for all patients was 30.6 months (95% confidence interval [CI], 27.4–34.2), and median OS was 55.6 months (95% CI, 51.8–58.9). Patients aged 65–75 years had significantly longer PFS and OS (p = 0.031 and p = 0.012) than patients aged under 65 and over 75 years. Visceral metastases were associated with shorter PFS and OS (p = 0.005). Comorbidity burden, including CCI score and comorbidity type, did not significantly affect survival outcomes. Interpretation: In our data set, univariate analyses suggest age and visceral metastases to be potential factors influencing outcomes in patients with ABC treated with palbociclib plus an AI. Comorbidities, did not significantly impact survival, suggesting that palbociclib is well-tolerated in patients with varying health profiles. ClinicalTrials.gov ID: NCT06307457. https://medicaljournalssweden.se/actaoncologica/article/view/43226Advanced Breast CancerPalbociclibCDK4/6 inhibitorsurvivalagecomorbidity |
| spellingShingle | Alan Celik Laurits Sebastian Dahl Rasmus Garly Vesna Glavicic Maja Bendtsen Sharma Sophie Yammeni Humma Khan Daniel Sloth Hauberg Hanne Schultz Kapel Ann Knoop Tobias Berg Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study Acta Oncologica Advanced Breast Cancer Palbociclib CDK4/6 inhibitor survival age comorbidity |
| title | Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study |
| title_full | Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study |
| title_fullStr | Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study |
| title_full_unstemmed | Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study |
| title_short | Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study |
| title_sort | impact of age and comorbidities on real world outcomes in advanced breast cancer patients treated with palbociclib in first line a nation wide danish retrospective study |
| topic | Advanced Breast Cancer Palbociclib CDK4/6 inhibitor survival age comorbidity |
| url | https://medicaljournalssweden.se/actaoncologica/article/view/43226 |
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