A comparative analysis of Palbociclib and Ribociclib in metastatic hormone receptor-positive, HER2-negative breast cancer: a prospective mid term follow-Up study from an Indian cohort.

INTRODUCTION

Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, such as Palbociclib and Ribociclib, have significantly improved outcomes for patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. Although clinical trials have established the efficacy of these agents globally, real-world data from India is limited. This study compares the clinical effectiveness and safety profiles of Palbociclib and Ribociclib in a cohort of Indian patients.

MATERIALS AND METHODS

This prospective study included 60 patients with metastatic HR+/HER2- breast cancer treated at Army hospitals and research centers in India between 2020 and 2023. Progression-free survival (PFS), overall survival (OS), and safety profiles were analyzed to assess the real-world performance of Palbociclib and Ribociclib. Patients were treated with either Palbociclib or Ribociclib in combination with standard endocrine therapy.

RESULTS

Among the 60 patients, the median PFS was 39.40 months for the Palbociclib group and 42.93 months for the Ribociclib group (p = 0.26), indicating no statistically significant difference. The median OS was 41.98 months in the Palbociclib group and 45.51 months in the Ribociclib group (p = 0.15), with Ribociclib showing a slight but non-significant survival advantage. The most common adverse event was neutropenia, which occurred in 26% of patients receiving Palbociclib and 23% of patients on Ribociclib. Deranged liver function tests (LFTs) and fatigue were also reported in both groups.

CONCLUSIONS

Palbociclib and Ribociclib demonstrated comparable efficacy and safety profiles in this Indian cohort. While no statistically significant differences in PFS or OS were observed, the data suggest a marginal survival benefit with Ribociclib. These findings underscore the importance of individualized treatment plans in HR+/HER2- breast cancer, taking into consideration patient-specific factors. Larger studies with longer follow-up are needed to further clarify the nuances between these two agents.