Real-world treatment patterns and outcomes in Indian patients with HR+/HER2- advanced breast cancer treated with palbociclib.

BACKGROUND

Palbociclib, a CDK4/6 inhibitor, was approved by FDA in 2015 for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). It was approved based on clinical benefits observed in PALOMA-1/TRIO-18 and PALOMA-2 Trial of Palbociclib. Despite its benefits in clinical studies, the data related to real-world outcomes are limited. This retrospective real-world observational study was designed to evaluate effectiveness of Palbociclib among Indian patients diagnosed with HR+/HER2- ABC.

METHODS

The study was conducted across six hospitals and enrolled 150 patients treated with Palbociclib and aromatase inhibitors or Fulvestrant from December 2016 to May 2021. It focused on the analysis of clinical characteristics, treatment patterns, and clinical outcomes of patients receiving Palbociclib combinations.

RESULTS

Of the 150 enrolled patients, 97% had ABC and 70% received Palbociclib as first-line therapy. The majority of patients (94.6%) received 125 mg/day Palbociclib as starting dose. 25.3% of patients required at least one dose adjustment. Overall, real-world response rate and the real-world clinical benefit rate across treatment lines were 68% and 75.3%, respectively. The overall persistence rate during the first six months of treatment was 62.9% for the first-line and 48.9% for the second-line therapies.

CONCLUSION

In India, where patients with BC often present at advanced stages due to late diagnosis and limited access to targeted therapies, Palbociclib offers a well-tolerated and effective treatment option. Real-world data from Indian patients highlight its role in bridging treatment gaps, making personalized therapy more accessible, and aligning treatment strategies with global standards.