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Study Shows Real-World Outcomes of First-Line Palbociclib Plus Fulvestrant in HR+, HER2– Metastatic Breast Cancer
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Key Takeaways
- Palbociclib plus fulvestrant shows favorable real-world outcomes for HR+, HER2– metastatic breast cancer, with significant efficacy in clinical trials and real-world studies.
- A retrospective study of 317 patients revealed a median progression-free survival of 19.6 months, with variations based on disease-free intervals.
Palbociclib is an oral CDK4/6 inhibitor that was approved by the FDA in 2017.
Palbociclib (Ibrance; Pfizer) plus fulvestrant (Faslodex; AstraZeneca) as a first-line treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2–) metastatic breast cancer (MBC) demonstrated favorable real-world clinical outcomes, according to data published in Future Oncology.1
Microscopic view of metastatic breast cancer cells development and progression | Image Credit: © ratirath - stock.adobe.com
HR+, HER2– MBC can be challenging to treat and accounts for approximately 10% of all BC cases. Advancements in therapeutic options, such as CDK4/6 inhibitors, have greatly improved outcomes for patients according to findings from clinical and real-world studies.2
Palbociclib is an oral CDK4/6 inhibitor that was approved by the FDA in 2017 for treatment of patients with HR+, HER2– MBC as initial therapy combined with an aromatase inhibitor in postmenopausal women or with fulvestrant in patients who experienced disease progression after endocrine therapy. It has demonstrated statistically significant capabilities in multiple trials when used in combination with other available treatments, such as the phase 3 AFT-38 PATINA trial (NCT02947685).2,3
In the real-world study (NCT04498481), researchers assessed the outcomes of patients with HR+, HER2– MBC who received first-line palbociclib and fulvestrant. They performed a retrospective observational study of electronic health records from the iKnowMed database among patients who initiated first-line palbociclib-fulvestrant between February 1, 2016, and December 31, 2019, and followed through June 30, 2020. The evaluation included demographic, clinical, and treatment characteristics. Multiple end points were used to determine the real-world outcomes of palbociclib and fulvestrant: real-world progression-free survival (PFS), overall survival (OS), time to chemotherapy, real-world duration of therapy, and time to next treatment were assessed using Kaplan–Meier methods from first-line treatment initiation.1,4
The researchers included 317 patients with a median age of 67.3 years of whom 90.5% were post-menopausal and 36.9% bone-only disease. According to the data, patients who received prior adjuvant treatment (n = 269), 66.2% (n = 178) had disease-free intervals (DFI) less than 12 months. The median real-world PFS was 19.6 months (95% CI 15.2–23.6) in the overall population compared with 13.9 months in patients who achieved a DFI less than 12 months and 33.6 months (19.6-NR) among those with a DFI of at least 12 months.1
These findings underscore the critical role of palbociclib and fulvestrant in the management of HR+, HER2– MBC, highlighting their ability to provide meaningful clinical benefits across diverse patient populations. The real-world PFS data, along with the observed improvements in OS and time to next treatment, emphasize the importance of CDK4/6 inhibitors in optimizing patient outcomes. As the treatment landscape continues to evolve, these results further validate the integration of palbociclib and fulvestrant as a foundational option for first-line therapy in this challenging disease setting.
REFERENCES
1. Robert N, Chen C, Doan, Venkatasetty D, et al. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncology. January 15, 2025. doi:10.1080/14796694.2024.2442302
2. Gerlach A. Palbociclib combination therapy improves outcomes for HR-positive, HER2-positive metastatic breast cancer. Pharmacy Times. January 8, 2025. Accessed January 17, 2025. https://www.pharmacytimes.com/view/palbociclib-combination-therapy-improves-outcomes-for-hr-positive-her2-positive-metastatic-breast-cancer
3. Randomized, open label, clinical study of the targeted therapy, palbociclib, to treat metastatic breast cancer (PATINA). Updated September 19, 2024. Accessed Junary 8, 2025. https://clinicaltrials.gov/study/NCT02947685
4. Treatment and monitoring patterns and clinical outcomes in patients receiving palbociclib combination treatment (with ai or fulvestrant) for HR+/HER2- A/mbc in a community oncology setting. Updated August 4, 2020. Accessed January 17, 2025. https://clinicaltrials.gov/study/NCT04498481
