It is critical to understand the real-world data (RWD) for palbociclib from countries outside of Western regions, given the higher breast cancer mortality and burden in these regions associated with delayed diagnosis and restricted access to quality healthcare.

This systematic scoping review evaluated RWD for palbociclib using PubMed and Embase databases from countries outside of Western regions that are underrepresented in clinical trials. Data analyses were conducted separately for abstracts and full-text citations to improve the accuracy of the results.

The comprehensive analysis of 1485 non-duplicate records, narrowed down to 46 eligible full-text publications involving 2048 patients, revealed a median progression-free survival (PFS) of first-line palbociclib plus endocrine therapy (ET) treatment ranging from 20.2 to 36.7 months and an objective response rate (ORR) of 45.3–80.0%.

In the second-line or later settings, palbociclib plus ET demonstrated a median PFS between 7.0 to 24.2 months and ORR from 13.9% to 47.9%, maintaining a safety profile in all treatment settings consistent with previous pivotal clinical studies.