Real-World Outcomes of Palbociclib Plus Anastrozole in Postmenopausal HR+ HER2- Recurrent, Unresectable or Metastatic Breast Cancer: A Retrospective Study from Central India

Dr. Diksha Mathu, Dr. Praghnya Tejale, Dr. Ashok Kumar Diwan, Dr. Vijay Kumar Mahobia, Dr. Pooja Gangharia

Abstract: Background: According to GLOBOCAN 2022, breast cancer accounts for 13.6% of all cancer cases in India, leading to a mortality rate of 10.7%. Current treatment guidelines recommend combining Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitors with endocrine therapy for patients with HR+/HER2-MBC, based on evidence from multiple phase III trials. Palbociclib, the first approved CDK4/6 inhibitor, has shown improved outcomes when combined with aromatase inhibitors in postmenopausal women with advanced disease, as demonstrated in the PALOMA-1 and PALOMA-2 trials. Objective: This study aims to observe the effect of treating post-menopausal HR+ Her2- recurrent, unresectable or metastatic breast cancer with a combination of Palbociclib plus Anastrozole by assessing progression-free survival (PFS) rates, adverse events and objective response. Methods: This was a retrospective observational study conducted at a tertiary care center in Central India. Sixty postmenopausal women with HR+ HER2- recurrent, unresectable, or metastatic breast cancer received either Anastrozole alone or a combination of Palbociclib and Anastrozole. Treatment was continued until disease progression or the development of unacceptable adverse events. Results: This retrospective observational study evaluates the combination of Palbociclib and Anastrozole in postmenopausal women with HR-positive, HER2-negative recurrent, unresectable, or metastatic breast cancer at a tertiary care center in Central India. Sixty patients were divided equally into two treatment groups: Anastrozole alone and Anastrozole plus Palbociclib. The combination therapy group demonstrated a longer progression-free survival (median not reached at 24 months) compared to the Anastrozole-only group (9 months, 95% CI: 7?11 months). While the combination treatment was associated with higher rates of adverse events, particularly neutropenia and anemia, no therapy discontinuations occurred due to toxicity. The study suggests that Palbociclib plus Anastrozole offers improved disease control with manageable side effects in real-world clinical practice. Conclusion: Palbociclib plus Anastrozole exhibited favourable effectiveness and manageable toxicities with better median PFS.

Keywords: Palbociclib, Anastrozole, metastatic breast cancer, hormone receptor-positive, real-world study

How to Cite?: Dr. Diksha Mathu, Dr. Praghnya Tejale, Dr. Ashok Kumar Diwan, Dr. Vijay Kumar Mahobia, Dr. Pooja Gangharia, "Real-World Outcomes of Palbociclib Plus Anastrozole in Postmenopausal HR+ HER2- Recurrent, Unresectable or Metastatic Breast Cancer: A Retrospective Study from Central India", Volume 14 Issue 7, July 2025, International Journal of Science and Research (IJSR), Pages: 913-919, https://www.ijsr.net/getabstract.php?paperid=SR25714115327, DOI: https://dx.doi.org/10.21275/SR25714115327