219 ISSN 1479-6694 Future Oncol. (2015) 11(2), 219–224 part of 10.2217/FON.14.170 © 2015 Future Medicine Ltd RESEARCH ARTICLE Everolimus as second-line therapy for metastatic renal cell carcinoma: a ‘real-life’ study Mimma Rizzo* ,1,2 , Gaetano Facchini 2,3 , Clementina Savastano 2,3 , Giuseppe Di Lorenzo 2,4 , Luigi De Lucia 2,5 , Luigi Maiorino 2,6 , Beniamino Casale 2,7 , Giuseppe Grimaldi 2,8 , Roberta Formato 2,9 , Antonio Febbraro 2,10 & Giacomo Cartenì 1,2 1 Cardarelli Hospital, Naples, Italy 2 S Giovanni di Dio e Ruggi d’Aragona Hospital, Salerno, Italy 3 National Tumor Institute Pascale, Naples, Italy 4 Federico II University, Naples, Italy 5 S Sebastiano e S Anna Hospital, Caserta, Italy 6 S Gennaro Hospital, Naples, Italy 7 Ospedale dei Colli, Naples, Italy 8 Umberto I Hospital, Nocera Inferiore, Italy 9 S Maria delle Grazie Hospital, Pozzuoli, Italy 10 Osp. Fatebenefratelli, Benevento * Author for correspondence: rizzo.mimma@gmail.com ABSTRACT Aims: This study, conducted in a ‘feld-practice’ scenario, investigates the efectiveness and safety of everolimus in the second-line treatment of metastatic renal cell carcinoma (mRCC) patients. Patients & methods: mRCC patients, who started everolimus 10 mg/day after failure of frst-line VEGF receptor-targeted tyrosine kinase inhibitor, were included in this study. Study end points were treatment response, progression-free survival and tolerability. Results: In total, 100 patients were assessed; the median duration of everolimus treatment was 7.1 months (95% CI: 5.7–8.5). A total of 19% of patients experienced a partial response and 62% of patients reached a stable disease. Median progression-free survival was 8 months (95% CI: 6.7–9.3). A total of 75% of patients experienced adverse events; no grade 4 adverse events were reported. Conclusion: These fndings, obtained in a ‘feld-practice’ scenario, support the use of everolimus for mRCC patients who failed one VEGF receptor-targeted tyrosine kinase inhibitor. KEYWORDS • everolimus • mRCC • observational studies • second-line therapy Everolimus is a rapamycin derivative that inhibits the mTOR kinase [1] . The mTOR pathway has a major role in several cellular processes, including cell cycle control and cellular proliferation [2–4] . In addition, mTOR is a downstream target of the PI3K/phosphatase and tensin homolog/AKT axis, often impaired in human tumors [5,6] . Therefore, the inhibition of mTOR with everolimus represents an effective strategy for the therapy of a number of solid tumors, including metastatic renal cell carcinoma (mRCC), neuroendocrine tumors of pancreatic origin and hormone receptor-positive, HER2-negative breast cancer in combination with exemestane [7] . In the mRCC setting, everolimus has been approved for the treatment of patients who failed treatment with tyrosine kinase inhibitors (TKIs) targeting the VEGF receptor (VEGFR), such as sunitinib, sorafenib or pazopanib [8,9] . In the multicenter, randomized, double-blind, Phase III RECORD-1 trial, everolimus 10 mg/day prolonged progression-free survival (PFS) when compared with placebo in patients with mRCC who had failed previous therapy with sunitinib and/or sorafenib [10] . Of note, only a small percent- age of patients enrolled in the RECORD-1 study actually received a second-line treatment with everolimus, while approximately 79% of them were undergoing a third-line or further-line treatment after failure of VEGFR-targeted TKIs [11] . Moreover, the safety population of this trial included less For reprint orders, please contact: reprints@futuremedicine.com