Real-World Data Confirm Pazopanib as Safe, Effective in mRCC

Investigators conducted a noninterventional, multicenter study (APOLON) in patients receiving frontline pazopanib therapy.

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Real-world data confirm pazopanib to be safe and effective in patients with metastatic renal cell carcinoma (mRCC), according to findings presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

To further assess the efficacy and safety of pazopanib in real-world clinical practice, investigators conducted a noninterventional, multicenter study (APOLON) in patients receiving frontline pazopanib therapy. APOLON evaluated progression-free survival (PFS), overall survival (OS), investigator-assessed objective response rate (ORR), and tolerability of pazopanib in mRCC patients. Additionally, the impact of the COVID-19 pandemic on patient care was also evaluated.

Eligible patients with mRCC (N=217) were included in the assessment, with a median age of 69.6 years. Patients were stratified by IMDC (International Metastatic RCC Database Consortium) risk score; 27.1% of patients had a favorable IMDC risk score, while 52.1% and 20.8% had an intermediate or poor score, respectively. Eastern Cooperative Oncology Group Performance Status was 0, 1 and 2 or more in 43.3%, 39% and 17.6% of patients, respectively. Metastases were primarily found in the lungs (64.1%), bones (28.6%), mediastinum (18%), and abdomen (17.1%).

Based on interim findings (30 months after enrollment), patients treated with pazopanib had a median PFS of 10.5 months (95% CI, 9-12.4), with a PFS of 11.3 months (95% CI, 7-16.3) in patients aged less than 65 years, and 9.9 months (95% CI, 8.9-12) in patients aged 65 years and older. When assessed by IMDC risk score, median PFS was 18.1 months (95% CI, 9.9-23.3), 11.5 months (95% CI, 8.7-14.4), and 6.2 months (95% CI, 3.5-9.5) in favorable, intermediate, and poor mRCC respectively.

Findings also showed a median OS of 27.3 months (95% CI, 24.3-ND) for mRCC patients treated with pazopanib. Investigator-assessed ORR was 48.3%, with a complete response in 6 patients (3.5%) and partial response in 77 patients (44.8%).

No new safety events were identified for pazopanib. Dose reductions and discontinuations due to adverse events occurred in 42% and 40.9% of patients, respectively. Treatment-related serious adverse events were reported in 22.2% of patients.

When assessing the effect of COVID-19, the authors found that the pandemic had limited impact on patient care. Patient visits and teleconsultation were conducted for tumor evaluation and follow-ups. Only 5.7% of patients had no visits during the pandemic.

Investigators concluded that pazopanib is safe and effective in patients with mRCC in the real-world setting. Additionally, “the efficacy of pazopanib remains significant in patients aged 65 years and older. It is highly associated with risk score,” the authors stated.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Thiery-Vuillemin A, Barthelemy P, Lebret T, et al. Real-word evidence in patients treated with pazopanib for advanced/metastatic renal cell carcinoma (mRCC): The APOLON study. Presented at: ASCO-GU 2022; February 17-19, 2022; Abstract 299.