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Efficacy and Treatment Outcomes of First-line Pazopanib Therapy in Advanced Renal Cell Carcinoma in Greece
Evangelos Bournakis1, Ioannis Xanthakis2, Michail Vaslamatzis3
1Iaso General Clinic, Athens, Greece.
Background/Aim:
Pazopanib is a tyrosine kinase inhibitor (TKI) approved as first-line treatment for renal cell carcinoma (RCC). Although pazopanib efficacy and safety have been established in phase III studies, real-world data are limited. The aim of this study was to evaluate pazopanib efficacy, duration of responses and safety, as first-line treatment in patients with advanced/metastatic RCC with favorable-intermediate prognosis.
Patients And Methods:
This single-arm prospective Greek observational study evaluated 59 patients treated with first-line pazopanib as indicated, and who were followed-up every 3 months for 2 years, or until disease progression. The primary objective was to evaluate the efficacy of first-line pazopanib treatment in patients with favorable-intermediate prognosis metastatic RCC at 9 months from treatment onset.
Results:
The primary composite efficacy point (complete response, partial response, or stable disease at 9 months) was reached by 30.5% [95% confidence interval (CI)=19.2-43.9%] of patients, with 27.1% (95% CI=16.4-40.3%) of patients demonstrating stable disease. Best overall response was complete response in 5.1% (3/59 patients), partial response in 22% (13/59 patients), and stable disease in 35.6% (21/59 patients). Median progression-free survival was 17.7 (95% CI=9.15-26.25) months and declined with the International Metastatic Renal Cell Carcinoma Database Consortium progressive risk (24.5 and 6.97 months for favorable- and intermediate-risk, respectively; p=0.012). The cumulative overall survival rate was 95% after 9 (95% CI=89.8-100.0%) months and 24 (95% CI=89.8-100.0%) months. Median overall survival was not reached. Overall, 234 adverse events were reported in 55 patients, of which the most common were malignant neoplasm progression, diarrhea, and hypertension.
Conclusion:
These data demonstrate that pazopanib is well-tolerated and effective as first-line treatment in patients with favorable-intermediate risk metastatic RCC in real-life conditions in Greece.
Insights
Pazopanib demonstrated efficacy and was well-tolerated as a first-line treatment for advanced renal cell carcinoma (RCC) in Greek patients with favorable-intermediate risk. Real-world data confirmed its effectiveness in this patient population.
Area of Science:
- Oncology
- Pharmacology
Background:
- Pazopanib is an approved tyrosine kinase inhibitor (TKI) for first-line treatment of renal cell carcinoma (RCC).
- Real-world data on pazopanib's efficacy and safety in advanced/metastatic RCC are limited.
- This study focuses on patients with favorable-intermediate prognosis.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of first-line pazopanib treatment.
- To assess treatment duration, response rates, and survival outcomes.
- To analyze safety and tolerability in a Greek patient cohort.
Main Methods:
- A single-arm, prospective, observational study in Greece.
- 59 patients with advanced/metastatic RCC received first-line pazopanib.
- Patients were followed for 2 years or until disease progression, with 3-month intervals.
Main Results:
- The primary efficacy endpoint (response at 9 months) was met by 30.5% of patients.
- Best overall response included 5.1% complete response, 22% partial response, and 35.6% stable disease.
- Median progression-free survival was 17.7 months, influenced by risk stratification. Overall survival rates were high at 9 and 24 months. Common adverse events included disease progression, diarrhea, and hypertension.
Conclusions:
- Pazopanib is well-tolerated and effective as a first-line treatment for metastatic RCC in patients with favorable-intermediate risk.
- Real-world data support pazopanib's role in managing this patient population in Greece.
- The study provides valuable insights into pazopanib's performance in routine clinical practice.
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