Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer
ABSTRACT Introduction Cyclin‐dependent kinase 4/6 inhibitors (CDK4/6is) in combination with endocrine therapy are the current standard of care for first‐line (1L) treatment of hormone receptor–positive and human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC)....
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| Format: | Article |
| Language: | English |
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Wiley
2025-04-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.70719 |
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| author | Adam M. Brufsky Rickard Sandin Stella Stergiopoulos Connie Chen Siddharth Karanth Benjamin Li Elizabeth Esterberg Doris Makari Sean D. Candrilli Ravi K. Goyal Hope S. Rugo |
| author_facet | Adam M. Brufsky Rickard Sandin Stella Stergiopoulos Connie Chen Siddharth Karanth Benjamin Li Elizabeth Esterberg Doris Makari Sean D. Candrilli Ravi K. Goyal Hope S. Rugo |
| author_sort | Adam M. Brufsky |
| collection | DOAJ |
| description | ABSTRACT Introduction Cyclin‐dependent kinase 4/6 inhibitors (CDK4/6is) in combination with endocrine therapy are the current standard of care for first‐line (1L) treatment of hormone receptor–positive and human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC). To investigate the effectiveness of palbociclib, the first‐in‐class CDK4/6i, plus an aromatase inhibitor (AI) in older patients, we compared overall survival (OS) in a Medicare population treated with 1L palbociclib + AI versus an AI alone. Methods Patients aged ≥ 65 years who were diagnosed with de novo HR+/HER2– mBC from 2015 to 2019 were identified from the Surveillance, Epidemiology, and End Results (SEER)–linked Medicare database and were eligible if they initiated 1L palbociclib + AI or an AI alone. The primary endpoint was OS. Stabilized inverse probability of treatment weighting (sIPTW) was used to balance baseline patient characteristics. Results Of 779 eligible patients, 296 received palbociclib + AI and 483 received AI alone as 1L treatment. After sIPTW, the median follow‐up was 23.1 months with palbociclib + AI and 18.2 months with AI alone. Adjusted median OS was longer with palbociclib + AI versus AI alone (sIPTW: 37.6 vs. 25.5 months, HR = 0.73 [95% CI, 0.59–0.91]). In multivariable Cox proportional hazards regression, patients treated with palbociclib + AI versus AI alone had a 39% lower risk of death (HR = 0.61 [95% CI, 0.48–0.77]). Conclusion In routine US clinical practice, palbociclib + AI was associated with significantly prolonged OS versus AI alone in 1L treatment of patients aged ≥ 65 years with de novo HR+/HER2– mBC, adding to the growing body of evidence on the survival benefit of palbociclib + AI in this patient population. Trial Registration ClinicalTrials.gov identifier: NCT06086340 |
| format | Article |
| id | doaj-art-dbae3d59e39f473da0df8ff281747d85 |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-dbae3d59e39f473da0df8ff281747d852025-08-20T02:16:13ZengWileyCancer Medicine2045-76342025-04-01147n/an/a10.1002/cam4.70719Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast CancerAdam M. Brufsky0Rickard Sandin1Stella Stergiopoulos2Connie Chen3Siddharth Karanth4Benjamin Li5Elizabeth Esterberg6Doris Makari7Sean D. Candrilli8Ravi K. Goyal9Hope S. Rugo10University of Pittsburgh Pittsburgh Pennsylvania USAPfizer AB Stockholm SwedenPfizer Inc. New York New York USAPfizer Inc. New York New York USARTI Health Solutions Research Triangle Park Raleigh North Carolina USAPfizer Inc. New York New York USARTI Health Solutions Research Triangle Park Raleigh North Carolina USAPfizer Inc. New York New York USARTI Health Solutions Research Triangle Park Raleigh North Carolina USARTI Health Solutions Research Triangle Park Raleigh North Carolina USAUniversity of California San Francisco San Francisco California USAABSTRACT Introduction Cyclin‐dependent kinase 4/6 inhibitors (CDK4/6is) in combination with endocrine therapy are the current standard of care for first‐line (1L) treatment of hormone receptor–positive and human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC). To investigate the effectiveness of palbociclib, the first‐in‐class CDK4/6i, plus an aromatase inhibitor (AI) in older patients, we compared overall survival (OS) in a Medicare population treated with 1L palbociclib + AI versus an AI alone. Methods Patients aged ≥ 65 years who were diagnosed with de novo HR+/HER2– mBC from 2015 to 2019 were identified from the Surveillance, Epidemiology, and End Results (SEER)–linked Medicare database and were eligible if they initiated 1L palbociclib + AI or an AI alone. The primary endpoint was OS. Stabilized inverse probability of treatment weighting (sIPTW) was used to balance baseline patient characteristics. Results Of 779 eligible patients, 296 received palbociclib + AI and 483 received AI alone as 1L treatment. After sIPTW, the median follow‐up was 23.1 months with palbociclib + AI and 18.2 months with AI alone. Adjusted median OS was longer with palbociclib + AI versus AI alone (sIPTW: 37.6 vs. 25.5 months, HR = 0.73 [95% CI, 0.59–0.91]). In multivariable Cox proportional hazards regression, patients treated with palbociclib + AI versus AI alone had a 39% lower risk of death (HR = 0.61 [95% CI, 0.48–0.77]). Conclusion In routine US clinical practice, palbociclib + AI was associated with significantly prolonged OS versus AI alone in 1L treatment of patients aged ≥ 65 years with de novo HR+/HER2– mBC, adding to the growing body of evidence on the survival benefit of palbociclib + AI in this patient population. Trial Registration ClinicalTrials.gov identifier: NCT06086340https://doi.org/10.1002/cam4.70719CDK4/6 inhibitorHR+/HER2– metastatic breast cancerolder adultsoverall survivalpalbociclibreal‐world evidence |
| spellingShingle | Adam M. Brufsky Rickard Sandin Stella Stergiopoulos Connie Chen Siddharth Karanth Benjamin Li Elizabeth Esterberg Doris Makari Sean D. Candrilli Ravi K. Goyal Hope S. Rugo Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer Cancer Medicine CDK4/6 inhibitor HR+/HER2– metastatic breast cancer older adults overall survival palbociclib real‐world evidence |
| title | Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer |
| title_full | Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer |
| title_fullStr | Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer |
| title_full_unstemmed | Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer |
| title_short | Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer |
| title_sort | overall survival with palbociclib and aromatase inhibitor versus aromatase inhibitor alone in older patients with hr her2 metastatic breast cancer |
| topic | CDK4/6 inhibitor HR+/HER2– metastatic breast cancer older adults overall survival palbociclib real‐world evidence |
| url | https://doi.org/10.1002/cam4.70719 |
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