Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials

Amit Rauthan ¹, Ankita Jain ², Manmohan Singh ³

⁰Department of Medical Oncology, Manipal Hospital, Bengaluru, India.

Oncology and Therapy +

|

August 2, 2024

View abstract on PubMed

Summary

Real-world data confirm palbociclib is effective and safe for advanced breast cancer outside Western regions. These findings support clinical decisions in underrepresented patient populations.

Area Of Science

Oncology
Pharmacology
Clinical Research

Background

Limited real-world data (RWD) exists for palbociclib in hormone receptor-positive, HER2-negative advanced/metastatic breast cancer.
Focus on patient populations from countries outside Western regions, which are underrepresented in clinical trials.

Purpose Of The Study

To systematically evaluate RWD for palbociclib in underrepresented global populations.
To assess the effectiveness and safety of palbociclib in real-world settings.

Main Methods

Systematic scoping review of PubMed and Embase databases.
Adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Phase 1 (title/abstract) and Phase 2 (full-text) screening of 1485 records; 46 studies included.

Main Results

Analysis of 46 studies (2048 patients) showed median progression-free survival (PFS) of 20.2-36.7 months (first-line) and 7.0-24.2 months (≥second-line).
Objective response rates (ORR) ranged from 45.3-80.0% (first-line) and 13.9-47.9% (≥second-line).
Palbociclib's safety profile in RWD matched pivotal clinical studies, with no new safety concerns identified.

Conclusions

Real-world evidence confirms palbociclib's efficacy and safety align with clinical trial findings.
These findings provide valuable insights for palbociclib treatment decisions in global regions underrepresented in research.
Supports the use of palbociclib in diverse patient populations with advanced/metastatic breast cancer.

Keywords:

Breast neoplasms CDK4/6 inhibitors Non-Western countries Palbociclib Real-world data Real-world evidence