ASPEN Compares Sunitinib, Everolimus in Metastatic Non-Clear Cell Renal Cell Carcinoma
Randomized trial identifies potential first-line therapy for patients with non-clear cell renal cell carcinoma.
Clinicians now have a better picture of what may be the optimal first-line therapy for patients with metastatic non-clear cell renal cell carcinoma (NC-RCC), according to results from a randomized phase 2 international trial of everolimus compared with sunitinib.
Investigators reported at the 2015 American Society of Clinical Oncology Annual Meeting that sunitinib was superior overall compared with everolimus at delaying disease progression. However, it was also associated with a higher rate of severe toxicity.1
The researchers found that sunitinib was more effective for papillary-type kidney cancers and for better prognosis patients.
Patients with chromophobe and poor-risk tumors treated with everolimus had a longer median progression-free survival (PFS) than patients treated with sunitinib.
“We wanted to know which was better. We don't a have a standard of care,” said lead study author Andrew Armstrong, MD, who is the co-director of the Genitourinary Oncology Research Program at Duke Cancer Institute in Raleigh, NC.
Known as ASPEN (Afinitor [RAD001] vs. Sutent (Sunitinib) in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma), this trial included 108 patients (57 patients received everolimus and 51 received sunitinib).
None of the patients had prior systemic therapy and they were divided into three categories of non-clear cell kidney cancers: metastatic papillary, chromophobe, or unclassified histology.
All the patients were enrolled between September 2010 and October 2013 across 17 sites and three countries. The median age was 63 and 75% of the patients were male.
Among the 108 patients, 66% had papillary disease, 15% had chromophobe, and 19% were unclassified. The patients were randomly assigned to receive either everolimus or sunitinib until their tumors progressed.
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Dr. Armstrong said during the study period there were 87 progression-free survival (PFS) events, 53 deaths, and two patients remaining on study treatment. Sunitinib improved overall PFS, meeting the primary endpoint and sunitinib improved PFS in good/intermediate risk and papillary and unclassified patients.
However, that was not the case in patients with chromophobe and patients classified as poor risk. They did a little better on everolimus. The median PFS was 5.6 months in patients treated with everolimus compared to 8.3 months in the sunitinib group.