Sunitinib improved progression-free survival compared with everolimus in patients with non-clear cell metastatic renal cell carcinoma (mRCC), a study published in the journal The Lancet Oncology has shown.1

Because non-clear cell RCCs are histologically and genetically diverse kidney cancers with variable prognoses that lack a known optimal initial treatment, researchers sought to compare sunitinib, a vascular endothelial growth factor receptor (VEGFR) inhibitor, with everolimus, a mammalian target of rapamycin (mTOR) inhibitor, in this patient population.

For the phase 2 study, researchers enrolled 108 patients with metastatic papillary, chromophobe, or unclassified non-clear cell RCC who had not received prior systemic therapy.

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Participants were randomly assigned 1:1 to receive either everolimus 10 mg orally daily continuously or sunitinib 50 mg orally daily for 4 weeks on, 2 weeks off, in 6-week cycles until disease progression or unacceptable toxicity.

Results showed that progression-free survival was 8.3 months (80% CI, 5.8 – 11.4) with sunitinib vs 5.6 months (80% CI, 5.5 – 6.0) with everolimus (HR, 1.41; 80% CI, 1.03 – 1.92; P = .16), but investigators observed different treatment effects depending on patients’ histological subtypes and prognostic risk groups.

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In regard to safety, the most common grade 3-4 adverse events in the sunitinib group were hypertension, infection, diarrhea, and hand-foot syndrome, while pneumonitis, stomatitis, and infection were the most frequent in the everolimus arm.

“Future trials of novel agents should account for heterogeneity in disease outcomes based on genetic, histological, and prognostic factors,” the authors noted.


  1. Armstrong AJ, Halabi S, Eisen T, et al. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial [published online ahead of print January 12, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00515-X.