ASCO GU 2022: Real-Word Evidence in Patients Treated With Pazopanib for Advanced/Metastatic Renal Cell Carcinoma: The APOLON Study

( The Poster Session C on the third day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022 focused on Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers. In this session, Dr. Thiery-Vuillemin presented The APOLON, its use, effectiveness, and safety in patients with metastatic renal cell carcinoma (mRCC) in clinical routine practices.

The APOLON study is a non-interventional, multicenter prospective study of mRCC patients who receive first-line pazopanib conducted at 55 sites in France. The authors include patients with mRCC who are naïve to anti-VEGF tarting therapy who initiated pazopanib. Data were collected at baseline and months 1, 2-3, 6, 9, 12, 18, 24, 30, and 36 months. The study is designed to assess progression-free survival (PFS) during pazopanib treatment, defined as the interval of time from treatment initiation to the earliest of disease progression or any cause of mortality. Important secondary endpoints include overall survival (OS), Objective Response Rate (ORR) assessed by investigators, tolerability and subsequent post-pazopanib therapy sequences. The effect of COVID-19 on patient’s care was also assessed by considering the occurrence of visits including in-person and teleconsultation in the pre-pandemic and pandemic periods.

Between November 2017 and January 2019, 217 eligible patients were recruited. The majority of patients have IMDC intermediate risk disease (52.1%) with 27.1% having favorable-risk disease and 20.8% having poor risk disease. Metastases were mainly located in lungs (64.1%), bones (28.6%), mediastinal (18%)/abdominal (17.1%). Patients had a history of partial/total nephrectomy in 54.8% of cases and previous local treatments for metastases in 27.6%. The median age was 69.6 years, 71.1% were men, and the distribution of ECOG-PS was 0, 1 and ≥2 was 43.3%, 39% and 17.6%, respectively.

The median investigator-assessed PFS was 10.5 months (95% CI 9-12.4), and did not differ significantly between those younger than 65years of age (11.3 months, 95% C: 7-16.3) and those older than 65 years of age (9.9 months, 95% CI 8.9-12).

ASCOGU22_APOLON study_0 

However, as expected, median PFS was longer among patients with favorable-risk disease (18.1 months, 95% CI 9.9-23.3) than intermediate (11.5 months, 95% CI 8.7-14.4) or poor risk disease (6.2 months, 95% CI 3.5-9.5). The median OS was 27.3 months (95% CI 24.3 - ND) and the investigator-assessed ORR was 48.3% with a complete response observed in 6 patients (3.5%) and a partial response in 77 (44.8%).

The median treatment duration of pazopanib therapy was 10.1 months. Among the 2017 included patients, 190 ceased pazopanib therapy during the observation period at a median of 5.4 months. Among these, 67.9% received at least one subsequent treatment including nivolumab (71.3%), cabozantinib (14.7%), sunitinib (7%) or other agents (7%).

Treatment-related adverse events (AEs) were reported in 191 patients (87.6%) of which 22% were serious. AEs leading to dose reduction and discontinuation were reported in 42% and 40.9% of patients No safety signal was newly identified. Notably, the authors found a limited, if any, the effect of the COVID-19 pandemic on the care of patients in this study.

Thus, they conclude that the APOLON study confirms the safety and effectiveness of pazopanib in a real world setting.

Presented by: Antoine Thiery-Vuillemin MD, PhD, University Hospital Jean Minjoz

Written by: Christopher J.D. Wallis, University of Toronto Twitter: @WallisCJD during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022




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