Real-World Efficacy and Adherence to Palbociclib in HR-Positive, HER2-Negative Advanced Breast Cancer: Insights from a Romanian Cohort
2024

Efficacy and Adherence to Palbociclib in Advanced Breast Cancer in Romania

Sample size: 125 publication 10 minutes Evidence: moderate

Author Information

Author(s): Lungulescu Cristian Virgil, Camen Georgiana-Cristiana, Naidin Mihaela-Simona, Berisha Tradian-Ciprian, Bita Andrei, Dinescu Venera-Cristina, Buteica Sandra Alice, Dimulescu Marina-Daniela, Volovat Simona Ruxandra, Turcu-Stiolica Adina

Primary Institution: University of Medicine and Pharmacy of Craiova, Romania

Hypothesis

The study aims to evaluate the efficacy, safety, and adherence to Palbociclib in combination with either an aromatase inhibitor or fulvestrant in HR+/HER2− breast cancer patients from Romania.

Conclusion

The study found no significant differences in overall survival between treatment combinations of Palbociclib with aromatase inhibitors and fulvestrant.

Supporting Evidence

  • Median time to treatment discontinuation was 19 months.
  • Median overall survival was 39 months.
  • Adherence to Palbociclib was high with a mean of 0.91.
  • 12-month TTD rates were higher for Palbociclib combined with AI than with fulvestrant.
  • Median OS for Palbociclib plus fulvestrant was 50.8 months.

Takeaway

This study looked at how well a cancer drug called Palbociclib works for women with a specific type of breast cancer in Romania, and it found that both treatment options are good choices.

Methodology

A retrospective analysis of reimbursed Palbociclib prescriptions was conducted using data from the Romanian Health Insurance House from 2018 to 2023.

Potential Biases

Limited data access may introduce bias in interpreting treatment outcomes.

Limitations

The study was limited to a specific region in Romania and lacked comprehensive data on patient history and treatment tolerability.

Participant Demographics

98% female, median age 62 years (IQR, 53–70).

Statistical Information

P-Value

0.249

Confidence Interval

95%CI, 19.3–24.9 months for TTD; 95%CI, 25.5–50.9 months for OS.

Statistical Significance

p=0.249

Digital Object Identifier (DOI)

10.3390/cancers16244161

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