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CC BY 4.0 · Indian J Med Paediatr Oncol
DOI: 10.1055/s-0044-1790584
Original Article

Clinical Benefit and Safety of Palbociclib in Hormone Positive Breast Cancer with Visceral Metastasis: Real-World Experience from a Tertiary Cancer Center

Sandeep K. S 
1   Department of Medical Oncology, Sri Shankara Cancer Hospital and Research Centre, Bengaluru, Karnataka, India
2   Nandadeepa cancer clinic, raichur, Karnataka, India
,
Sandhya Appachu
1   Department of Medical Oncology, Sri Shankara Cancer Hospital and Research Centre, Bengaluru, Karnataka, India
,
Ravi B. Diwaker
1   Department of Medical Oncology, Sri Shankara Cancer Hospital and Research Centre, Bengaluru, Karnataka, India
,
Sai Vivek
1   Department of Medical Oncology, Sri Shankara Cancer Hospital and Research Centre, Bengaluru, Karnataka, India
,
Vijai V.S. Simha
1   Department of Medical Oncology, Sri Shankara Cancer Hospital and Research Centre, Bengaluru, Karnataka, India
› Author Affiliations Funding None.
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Abstract

Introduction Palbociclib, the first CDK4/6 inhibitor, has shown promising results in phase III clinical studies by enhancing the efficacy of endocrine therapy (ET) in HR +/HER2– advanced breast cancer. However, real-world data on its use in patients with visceral metastatic disease are limited. We aimed to assess the effectiveness and tolerability of palbociclib in this high-risk population across different lines of treatment.

Materials and Methods Patients with hormone-positive metastatic breast cancer who received palbociclib with ET between 2015 and 2021 were grouped into skeletal and visceral metastatic disease. Visceral metastatic diseases were subclassified into lung, liver, and brain metastatic diseases. All subgroups were analyzed for progression-free survival (PFS), toxicity, and prognostic factors. Subgroups were compared using the chi-square test, and survival analyses were done using the Kaplan–Meier test.

Results Among 100 patients who received palbociclib, 70 had progressed on previous ET. The common metastatic site was bone (56%), followed by lung (24%), liver (18%), and brain (2%). With a median follow-up of 37 months, the median PFS of the overall population was 24 months: bone metastasis 27 months, lung 25 months, liver 12 months, and brain 4 months. Weak hormone positivity, ET-resistant metastatic patients, and high grade were associated with poorer responses. The common side effects were neutropenia (40%), anemia (35%), thrombocytopenia (15%), and hepatotoxicity (10%). Three percent of patients discontinued treatment due to toxicity.

Conclusion Palbociclib with ET showed improved PFS and safety in visceral metastatic disease, comparable to randomized controlled trials. However, further studies are required to evaluate its efficacy in extensive visceral metastatic disease and previously heavily treated patients.

Keywords

CDK4/6 inhibitors - palbociclib - visceral metastatic breast cancer - metastatic hormone-positive breast cancer

Patient Consent

Informed patient consent was obtained to conduct this study.


Source(s) of Support

None.




Publication History

Article published online:
17 September 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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