The following is a summary of “Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma,” published in the April 2023 issue of Oncology by Motzer, et al.

For a study, researchers sought to report final survival analyses and updated results of a randomized phase III trial that demonstrated the superiority of sunitinib over interferon alfa (IFN-α) in progression-free survival (primary endpoint) as first-line treatment for metastatic renal cell carcinoma (RCC).

Seven hundred fifty treatment-naïve patients with clear metastatic cell RCC were randomly assigned to sunitinib 50 mg orally once daily for 4 weeks on, 2 weeks off dosing schedule or to IFN-α 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. In addition, progression-free survival, response, and safety endpoints were assessed with updated follow-up.

The median overall survival was more significant in the sunitinib group than in the IFN-α group (26.4 vs 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051). The primary analysis of the unstratified log-rank test showed a statistically significant difference (P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN-α group, 33% of patients received sunitinib, and 32% received another vascular endothelial growth factor–signaling inhibitor after discontinuing the trial. The median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-α (P < .001). The objective response rate was 47% for sunitinib compared with 12% for IFN-α (P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).

The final analysis of the phase III trial demonstrated that sunitinib provides longer overall survival compared with IFN-α and improved response and progression-free survival in the first-line treatment of patients with metastatic RCC. The results highlighted an improved prognosis in patients with RCC in the era of targeted therapy.

Source: ascopubs.org/doi/full/10.1200/JCO.22.02623