DGI-062 Sorafenib, Sunitinib and Everolimus in Metastatic Renal Cell Carcinoma: Efficacy and Safety

• Published in: European journal of hospital pharmacy. Science and practice Vol. 20; no. Suppl 1; p. A118
• Main Authors: Ormazabal Goicoechea, I, Polanco Paz, M, Sanmartin Fenollera, P, Perez Encinas, M
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.03.2013
• Subjects: Kidney cancer; Neutropenia
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2013-000276.328

Background Tyrosine kinase inhibitors (TKIs) and m-TOR inhibitors (m-TORIs) have demonstrated clinical efficacy in patients with advanced renal cell carcinoma (aRCC). Abstract DGI-061 Table 1 Adverse event Telaprevir (%) Boceprevir (%) Influenza-like illness 61.8 64.7 Tiredness 85.3 82.4 Mood disorders 32.4 70.6 Digestive disorders 67.7 76.5 Dermatological disorders 70.6 52.9 Hair lost 5.9 17.7 Non-productive cough 8.8 29.4 Itchy eyes 0.0 5.9 Oral disorders 32.4 33.3 Haemorrhoids 64.7 0.0 Tachycardia 2.9 23.5 Decreased libido 2.9 11.8 Oedema 11.8 11.8 Anaemia 55.9 47.6 Neutropenia 17.7 11.8 Thrombocytopenia 14.7 5.9 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. ResultsOf 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.