Sunitinib in Advanced Renal Cell Carcinoma: Clinical Evidence

ContextThe development of targeted agents has improved the outlook for patients with metastatic renal cell carcinoma (mRCC). Sunitinib is an oral, multitargeted receptor tyrosine kinase inhibitor with antitumor and antiangiogenic activities. In mRCC, sunitinib has demonstrated efficacy for the treatment of cytokine-refractory and previously untreated mRCC.ObjectiveThis article reviews the available efficacy data from sunitinib clinical studies, including data that led to the approval of sunitinib for mRCC.Evidence acquisitionThe efficacy data from sunitinib phase 2 and 3 trials as well as the expanded-access study were examined.Evidence synthesisIn a pivotal phase 3 trial in treatment-naïve mRCC patients, sunitinib was found to provide significantly superior efficacy compared with interferon-α (IFN-α; assessed as progression-free survival [PFS] and objective response). The median PFS was 11.0 mo (95% confidence interval [CI]: 10.7–13.4) in patients treated with sunitinib and 5.1 mo in IFN-α–treated patients (95% CI: 3.9–5.6; p < 0.000001). Sunitinib also demonstrated antitumor activity in two phase 2 trials of patients with cytokine-refractory mRCC. The expanded-access study provided access to sunitinib for patients ineligible for participation in the registrational studies and provides a useful insight into the profile of sunitinib in a heterogeneous mRCC population, including subgroups such as older patients (≥65 yr), patients with brain metastases, patients with poor performance status (PS ≥2), and patients with non–clear-cell histology.ConclusionsSunitinib is considered a reference standard of care for the first-line treatment of patients with mRCC, which is reflected in the current treatment guidelines. Sunitinib is now approved multinationally for the first- and second-line treatment of advanced renal cell carcinoma and/or mRCC.