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DGI-062 Sorafenib, Sunitinib and Everolimus in Metastatic Renal Cell Carcinoma: Efficacy and Safety
  1. I Ormazabal Goicoechea,
  2. M Polanco Paz,
  3. P Sanmartin Fenollera,
  4. M Perez Encinas
  1. Hospital Universitario Fundación Alcorcón, Pharmacy, Madrid, Spain

Abstract

Background Tyrosine kinase inhibitors (TKIs) and m-TOR inhibitors (m-TORIs) have demonstrated clinical efficacy in patients with advanced renal cell carcinoma (aRCC).

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Abstract DGI-061 Table 1

Purpose To describe one centre’s experience with the use of TKIs and an oral m-TORI in patients with aRCC.

Materials and Methods Retrospective observational study of patients with aRCC treated with TKIs (sorafenib, sunitinib) and an m-TORI (everolimus) from March 2007–May 2012. Variables: demographics, initial ECOG, line number, duration (TT) and reason for stopping treatment, best response (partial response (PR), stable disease (SD), progression) according to clinical and radiological criteria; progression-free survival (PFS) and overall survival (OS) in weeks (w) and toxicity.

Results Of the 22 patients studied 81.8% were male with an average age of 65.77 years (SD: 11.76): 5 treated with sorafenib, 13 with sunitinib and 4 with everolimus.

Reasons for discontinuing were: 40% (2/5), 46.15% (6/13) and 75% (3/4) progression/clinical worsening; 40% (2/5), 15.38% (2/13) and 25% (1/4) toxicity; and 20% (1/5), 15.38% (2/13) and 0% death, for sorafenib, sunitinib and everolimus respectively. Response rates were (except the 5 patients who stopped too early): sorafenib 100% SD (2/2); sunitinib 25% SD (3/12), 58.33% PR (7/12) and 16.6% progression (2/12) and everolimus 100% progression (3/3).

Treatment-related adverse events: sorafenib 60% asthenia and 40% rash; sunitinib: 53.85% rash, 46.15% diarrhoea and 38.46% neutropenia, mucositis and asthenia, and everolimus: 75% hypercholesterolemia, 50% hypertriglyceridemia and 25% pneumonitis.

Conclusions In our study, median OS was lower than those obtained in pivotal trials, instead, median PFS was higher, except everolimus. Regarding safety, sorafenib had similar toxicity; sunitinib had higher rates of hand-foot syndrome and everolimus had higher rates of hypercholesterolemia. However, the small number of patients limits our conclusions.

No conflict of interest.

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