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Mar 30, 2024, 11:36

Piotr J. Wysocki: Pembrolizumab remains the only drug active in adjuvant settings in RCC – updated results of the ECOG-ACRIN E2810 on adjuvant pazopanib

Piotr J. Wysocki, Head of the Oncology Department at the 

“The results of the phase III, double-blind ECOG-ACRIN E2810 study have just been published online in the Journal of Clinical Oncology. Appleman LJ et al. randomized 129 RCC (clear-cell cancer) patients with no evidence of disease (NED) within 4-14 weeks after metastasectomy in a 1:1 ratio to pazopanib or placebo. Patients received adjuvant treatment with pazopanib 800 mg/d or placebo for 12 months.
With a median follow-up of 60.5 months, the 3-year disease-free survival rate (DFS – primary endpoint) was 27.4% for pazopanib and 21.9% for placebo, which translated into an HR for DFS of 0.90 (95%CI 0.60-1.34). However, the trend towards improved DFS stayed in sharp contrast to overall survival (OS). The 3-year OS rate for pazopanib was 81.9%, while for placebo, it was 91.4%. The relative risk of death in patients receiving adjuvant pazopanib was increased more than 2-fold (HR for OS = 2.55 (95%CI 1.23-5.27).
The results of ECOG-ACRIN E2810 demonstrate that adjuvant treatment with pazopanib (a tyrosine-kinase inhibitor—TKI) in patients with RCC and NED after metastasectomy has a detrimental impact on their outcomes. Another study on adjuvant TKI (the S-TRAC study on sunitinib), 6 years ago (2018), demonstrated a significant improvement in DFS compared to placebo, has included solely patients following nephrectomy, and has not updated overall survival data. It is very intriguing if there is the same trend as in the ECOG-ACRIN study toward poorer outcomes in patients treated with adjuvant sunitinib.
Nevertheless, the only adjuvant treatment in high-risk clear-cell RCC patients following nephrectomy or in NED RCC patients following metastasectomy remains pembrolizumab which significantly improves both DFS and OS – HR for OS = 0.62 (95%CI 0.44-0.87); HR for DFS = 0.72 (95%CI 0.59-0.87) – Choueri TK et al. GUCASYM 2024”

Source: Piotr J. Wysocki/LinkedIn