// Chenjing Zhu 1, * , Xuelei Ma 1, * , Yuanyuan Hu 2 , Linghong Guo 2 , Bo Chen 3 , Kai Shen 1 , Yue Xiao 2 1 State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, and Collaborative Innovation Center for Biotherapy, Chengdu 610041, PR China 2 West China School of Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China 3 Department of Oncology, The First People’s Hospital of Chengdu City, Chengdu 610041, PR China * These authors have contributed equally to this work Correspondence to: Xuelei Ma, email: drmaxuelei@gmail.com Keywords: safety, efficacy, lenvatinib, cancer, meta-analysis Received: January 30, 2016 Accepted: May 17, 2016 Published: June 14, 2016 ABSTRACT To systematically review the safety and efficacy of lenvatinib in the treatment of patients, we retrieved all the relevant clinical trials on the adverse events (AEs) and survival outcomes of lenvatinib through PubMed, Medline, Embase, Web of Science and Cochrane Collaboration's Central register of controlled trial. Fourteen eligible studies involving a total of 978 patients were included in our analysis. The most common all-grade AEs observed in patients treated with lenvatinib were hematuria (56.6%), fatigue (52.2%) and decreased appetite (50.5%). The most frequently observed grade ≥3 AEs were thrombocytopenia (25.4%), hypertension (17.7%) and edema peripheral (15.5%). The incidences of both all-grade and high-grade hypertension were significantly increased. Meanwhile, the controlled trial suggested that progression free survival (PFS) was significantly longer in the lenvatinib group than the placebo group. Subgroup analyses showed that mean PFS for renal cell carcinoma was 10.933±1.828 months (95% CI 7.350-14.515, p < 0.001), and that for thyroid cancer was 18.344±0.083 months (95% CI 18.181-18.506, p < 0.001). In conclusion, lenvatinib is an effective agent in thyroid cancer. Early monitoring and effective management of side effects are crucial for the safe use of this drug.
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