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Real-World Data Analysis of CDK4/6 Inhibitor Therapy-A Patient-Centric Single Center Study
Isabell Ge1,2,3,4, Kai Berner3,4,5, Marlene Mathis3,4
1Department of Gynecology and Obstetrics, University Hospital Basel, 4031 Basel, Switzerland.
Background:
The quest to comprehend the real-world efficacy of CDK4/6 inhibitors (CDKis) in breast cancer continues, as patient responses vary significantly.
Methods:
This single-center retrospective study evaluated CDKi use outside the trial condition from November 2016 to May 2020. Progression-free survival (PFS), time-to-treatment failure (TTF), short-term and prolonged treatment benefit (≥4 and ≥10 months), as well as prognostic and predictive markers were assessed with Kaplan-Meier and multivariate regression analyses.
Results:
Out of 86 identified patients, 58 (67.4%) had treatment failure of which 40 (46.5%) were due to progression. Median PFS and TTF were 12 and 8.5 months, respectively. A total of 57 (66.3%) and 42 (48.8%) patients experienced short-term and prolonged treatment benefit. Independent, significant predictors for PFS were progesterone receptor expression (HR: 0.88), multiple metastatic sites (HR: 2.56), and hepatic metastasis (HR: 2.01). Significant predictors for TTF were PR expression (HR: 0.86), multiple sites (HR: 3.29), adverse events (HR: 2.35), and diabetes (HR: 2.88). Aside from tumor biology and adverse events, treatment modifications like pausing and switching of CDKi were predictive for short-term (OR: 6.73) and prolonged (OR: 14.27) therapeutic benefit, respectively.
Conclusions:
These findings emphasize the importance of tailored treatment strategies, highlighting the role of PR expression, metastatic burden, and therapeutic adjustments in optimizing patient outcomes in real-world breast cancer management.
Insights
Real-world CDK4/6 inhibitors (CDKis) show varied breast cancer efficacy. Progesterone receptor status, metastatic sites, and treatment adjustments significantly impact outcomes, guiding personalized strategies.
Area of Science:
- Oncology
- Pharmacology
Background:
- Real-world effectiveness of CDK4/6 inhibitors (CDKis) in breast cancer is under investigation due to significant patient response variability.
- Understanding factors influencing treatment outcomes is crucial for optimizing patient care.
Purpose of the Study:
- To evaluate the real-world efficacy of CDK4/6 inhibitors (CDKis) in breast cancer patients outside of clinical trials.
- To identify prognostic and predictive markers associated with treatment response and failure.
Main Methods:
- A single-center retrospective study analyzed data from November 2016 to May 2020.
- Progression-free survival (PFS), time-to-treatment failure (TTF), and treatment benefit were assessed.
- Kaplan-Meier and multivariate regression analyses were employed to identify significant predictors.
Main Results:
- Of 86 patients, 67.4% experienced treatment failure, with 46.5% due to progression. Median PFS was 12 months and TTF was 8.5 months.
- 66.3% and 48.8% of patients achieved short-term and prolonged treatment benefit, respectively.
- Progesterone receptor expression, multiple metastatic sites, hepatic metastasis, adverse events, and diabetes were significant predictors for PFS and TTF. Treatment modifications predicted benefit.
Conclusions:
- Tailored treatment strategies are essential for optimizing outcomes in real-world breast cancer management.
- Progesterone receptor expression, metastatic burden, and therapeutic adjustments are key factors in patient response to CDK inhibitors.
- Further research into personalized treatment approaches is warranted.
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