ESMO real world data and digital oncology · 2025
Real-word evidence in anti-VEGF naive patients treated with pazopanib for metastatic renal cell carcinoma (mRCC), the APOLON Study.
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Barthelemy P, Thiery-Vuillemin A, Lebret T, Bigot P, Stein U, Dourthe L M, Longo R, Gimel P, Auberger B, De La Cruz J, Malak D, Samia Z, Texier N, Albiges L
Аннотация
BACKGROUND: Immune checkpoint inhibitor-based combinations have become the standard of care for treatment-naive metastatic renal cell carcinoma (mRCC). Tyrosine kinase inhibitor (TKI) monotherapy, however, may remain an option particularly for patients with a favourable International Metastatic Database Consortium (IMDC) risk.
MATERIAL AND METHODS: APOLON is a non-interventional, multicentric prospective study with mRCC patients receiving frontline pazopanib treatment, designed to assess progression-free survival (PFS), overall survival (OS), objective response rate, tolerability, and subsequent post-pazopanib therapy sequences.
RESULT: The 217 patients were 71.0% male, with a median age of 69.6 years, an Eastern Cooperative Oncology Group performance status ≥2 in 17.6%, and mRCC with a favourable (27.1%), intermediate (52.1%) or poor (20.8%) IMDC score. Metastases were mainly located in lung (64.1%), bone (28.6%), mediastinal (18%)/abdominal (17.1%) lymph nodes. Median PFS was 10.6 months [95% confidence interval (CI) 9-12.5 months], similarly in patients aged <65 years with PFS 11.3 months (95% CI 6.8-16.1 months) and aged ≥65 years with PFS 10.1 months (95% CI 9.0-12.4 months). The median PFS was 17.1 months (95% CI 9.9-23.2 months), 12.5 months (95% CI 9.0-15.4 months) and 6.2 months (95% CI 3.5-9.5 months) in patients with a favourable, intermediate, and poor IMDC score, respectively. The median OS was 29.1 months (95% CI 24.3-41.3 months). Objective response rate was 48.3% with a complete response in 6 (3.5%) and a partial response in 77 patients (44.8%). Grade 3/4 adverse events were reported in 45.8% of patients. No safety signals were newly identified.
CONCLUSION: The APOLON study confirmed pazopanib effectiveness and safety in patients with mRCC in a real-world setting. The efficacy remained significant in patients aged ≥65 years and was highly associated with the risk score.
MATERIAL AND METHODS: APOLON is a non-interventional, multicentric prospective study with mRCC patients receiving frontline pazopanib treatment, designed to assess progression-free survival (PFS), overall survival (OS), objective response rate, tolerability, and subsequent post-pazopanib therapy sequences.
RESULT: The 217 patients were 71.0% male, with a median age of 69.6 years, an Eastern Cooperative Oncology Group performance status ≥2 in 17.6%, and mRCC with a favourable (27.1%), intermediate (52.1%) or poor (20.8%) IMDC score. Metastases were mainly located in lung (64.1%), bone (28.6%), mediastinal (18%)/abdominal (17.1%) lymph nodes. Median PFS was 10.6 months [95% confidence interval (CI) 9-12.5 months], similarly in patients aged <65 years with PFS 11.3 months (95% CI 6.8-16.1 months) and aged ≥65 years with PFS 10.1 months (95% CI 9.0-12.4 months). The median PFS was 17.1 months (95% CI 9.9-23.2 months), 12.5 months (95% CI 9.0-15.4 months) and 6.2 months (95% CI 3.5-9.5 months) in patients with a favourable, intermediate, and poor IMDC score, respectively. The median OS was 29.1 months (95% CI 24.3-41.3 months). Objective response rate was 48.3% with a complete response in 6 (3.5%) and a partial response in 77 patients (44.8%). Grade 3/4 adverse events were reported in 45.8% of patients. No safety signals were newly identified.
CONCLUSION: The APOLON study confirmed pazopanib effectiveness and safety in patients with mRCC in a real-world setting. The efficacy remained significant in patients aged ≥65 years and was highly associated with the risk score.