1. Atezolizumab was associated with non-significantly increased disease-free survival compared to placebo (57.2 months vs. 49.5 months).

2. Serious adverse events were more numerically more common in atezolizumab (18%) versus placebo (12%).

Evidence Rating Level: 1 (Excellent)

Study Rundown: Surgery is the standard of care for localized renal cell carcinoma. Despite this, the 5-year recurrence post-resection remains high, ranging from 10% to 68%. Atezolizumab is an anti-programmed death-ligand 1 (PD-L1) antibody that may mitigate the risk of recurrence in patients with higher risk renal cell carcinomas. However, current research on its efficacy is limited. This randomized controlled trial aimed to determine the safety and efficacy of atezolizumab for post-resection recurrence in patients with renal cell carcinoma. The primary outcome was disease-free survival. According to study results, atezolizumab did not significantly improve disease-free survival in this cohort. Any-grade and high-grade adverse events were comparable between the treatment groups. This study was strengthened by a large sample size with patients from various countries, thus increasing its generalizability.

Click to read the study in The Lancet

Relevant Reading: Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma

In-depth [randomized-controlled trial]: Between Jan 3, 2017, and Feb 15, 2019, 1399 patients were screened for eligibility across 215 centers in 28 countries. Included were those aged ≥18 years with high risk of recurrence for renal cell carcinoma. Altogether, 778 patients (390 to atezolizumab and 388 to placebo) were included in the final analysis. The primary endpoint of disease-free survival was numerically greater in the atezolizumab group (57.2 months) compared to placebo (49.5 months), although this was not statistically significant (hazard ratio [HR] 0.93, 95% CI 0.75-1.15; p=0.50). The occurrence of grade 3-4 adverse events was similar between groups including hypertension (2% in atezolizumab vs. 4% in placebo), hyperglycemia (3% vs. 2%), and diarrhea (1% vs. 2%). Serious adverse events were more common in the atezolizumab group (18% vs. 12% in placebo); however, there were no reported treatment-related deaths. Findings from this study suggest that atezolizumab did not show improved clinical outcomes than placebo for post-resection recurrence in patients with renal cell carcinoma.

Image: PD

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