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

Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23.

Abstract

Background: We investigated the efficacy of everolimus against nonclear-cell renal cell carcinoma (nccRCC). Patients and methods Patients 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.

Results: A 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.

Conclusion: Everolimus 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 number NCT00830895.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antineoplastic Agents / administration & dosage
  • Bevacizumab
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / mortality
  • Carcinoma, Renal Cell / pathology
  • Disease-Free Survival
  • Everolimus
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / mortality
  • Kidney Neoplasms / pathology
  • Male
  • Middle Aged
  • Protein Kinase Inhibitors / administration & dosage
  • Sirolimus / administration & dosage*
  • Sirolimus / analogs & derivatives*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Immunosuppressive Agents
  • Protein Kinase Inhibitors
  • Bevacizumab
  • Everolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00830895