Overview
In addition to results from randomized controlled trials (RCTs), real-world (RW) evidence can inform patients and clinicians. Ribociclib (RIB) plus endocrine therapy (ET) is approved for first-line treatment of hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC). The objective of this retrospective study was to describe the RW tolerability of RIB+ET in patients diagnosed with HR+/HER2- mBC in the United States (US).
This retrospective cohort study reaffirmed observed tolerability and safety, as reported across the MONALEESA RCTs, for RIB+ET using data from 2 large US databases. The researchers saw no new RW safety or tolerability signals and confirmed the safety of first line RIB+ET observed in RCTs, including for older patients.
Why this matters
Using real-world data, this research provides evidence that can reassure clinicians and complement information provided by RCTs on the safety of RIB+ET as a beneficial treatment option for patients with metastatic breast cancer.