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Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma

2012; Elsevier BV; Volume: 24; Issue: 4 Linguagem: Inglês

10.1093/annonc/mds582

1569-8041

Youngil Koh, Ho Yeong Lim, J.-H. Ahn, J. L. Lee, Sun Young Rha, Yoon Jun Kim, T. M. Kim, Seung‐Hoon Lee,

Cancer Genomics and Diagnostics

BackgroundWe investigated the efficacy of everolimus against nonclear-cell renal cell carcinoma (nccRCC).Patients and methodsPatients with nccRCC received 10-mg everolimus once daily until disease progression or unacceptable toxicity. Patients who had received a VEGF- tyrosine kinase inhibitor (TKI) previously were included.ResultsA total of 49 patients were enrolled. Twenty-three patients (46.9%) received prior anti-VEGF agents. A partial response was observed in five patients (10.2%) and stable disease in 25 patients (51.0%). The disease progressed in 16 patients (32.7%) despite the administration of everolimus. Two of the five patients who showed an objective response to everolimus had chromophobe carcinoma, whereas two had papillary carcinoma and one had unclassifiable carcinoma. Thirty-six patients experienced disease progression during follow-up, and the median progression-free survival (PFS) was 5.2 months. Chromophobe RCC patients seemed to have longer PFS than nccRCC patients with the other histological subtypes (P = 0.084). Previous VEGF-TKI treatment did not influence the efficacy of everolimus, and the toxicity profiles were in line with previous reports.ConclusionEverolimus shows certain efficacy against nccRCC, particularly in patients with chromophobe RCC, and prior treatment with a VEGF-TKI appears not influencing the outcome of everolimus therapy in nccRCC patients.ClinicalTrials.gov numberNCT00830895.