Recommendations on managing lenvatinib and everolimus in patients with advanced or metastatic renal cell carcinoma

There are several second-line treatment options for patients with renal cell carcinoma after first-line failure of a tyrosine kinase inhibitor, especially with the recent approvals of cabozantinib, nivolumab, and the lenvatinib plus everolimus combination. A lack of reliable biomarkers and an overall lack of prospective head-to-head comparisons make it a challenge to choose a second-line treatment in the clinic. Areas covered: In this review/meta-opinion, we describe the safety profile of the lenvatinib plus everolimus combination in renal cell carcinoma. The combination of lenvatinib plus everolimus has achieved the highest rates of objective responses and the longest progression free and overall survival in cross-comparison trials. At the same time, the safety profile of this combination, including the rate of total and severe adverse events, the percentage of dose reductions required, and the rate of treatment discontinuation, was less favorable compared with available monotherapy options, suggesting that better management could help to maximize the activity of this combination while protecting patients from undue harm. Expert opinion: Herein, we aim to postulate multidisciplinary recommendations on the advice to offer to patients and caregivers before starting treatment and how to manage the combination from the perspective of daily clinical practice.

Expert opinion on drug safety. 2017 Sep 18 [Epub ahead of print]

E Grande, H Glen, J Aller, G Argenziano, M J Lamas, P Ruszniewski, J L Zamorano, K Edmonds, S Sarker, M Staehler, J Larkin

a Medical Oncology Department , Ramón y Cajal University Hospital , Carretera Colmenar Km 9,1. 28034 Madrid . Spain ., b Consultant in Medical Oncology, Honorary Clinical Senior Lecturer, NRS Research Fellow , Beatson West of Scotland Cancer Centre , 1053 Great Western Road, Glasgow G12 0YN . United Kingdom ., c Endocrinology Department , Puerta de Hierro University Hospital , Calle Manuel de Falla, 1, 28222 Majadahonda, Madrid . Spain ., d Dermatology Unit , University of Campania , Via Pansini 5, 80131 Naples . Italy ., e Pharmacy Department , Complexo Hospitalario de Santiago de Compostela , Travesía de Choupana, s/n, 15706 Santiago de Compostela . Spain ., f Paris Diderot University. Gastroenterology Department , Beaujon Hospital, Assistance Publique-Hôpitaux de Paris , 100 Boulevard du Général Leclerc, 92110 Clichy . France ., g Head of Cardiology, CIBERCV , University Hospital Ramon y Cajal , Carretera de Colmenar Km 9,100 28034 Madrid . Spain ., h Oncology Nurse , Royal Marsden Hospital , 203 Fulham Rd, Chelsea, London SW3 6JJ . United Kingdom ., i Urology Department , Klinikum der Ludwig-Maximilians Universität , Marchioninistraße 15, 81377 Munich . Germany ., j Medical Oncology Department , Royal Marsden Hospital , 203 Fulham Rd, Chelsea, London SW3 6JJ . United Kingdom .