·To observe the efficacy and safety of anlotinib in the treatment of refractory natural killer/T-cell lymphoma (NKTCL).

·The patients who had been pathologically diagnosed as having NKTCL with measurable/assessable lesions and some organ function reserve after failing in L-asparaginase-containing regimen were recruited in this study from August 2018 to December 2019 in the Outpatient Department of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. They were given anlotinib (12 mg/d) alone or anlotinib (10 mg/d) with programmed death-1 (PD-1) monoclonal antibody until the disease progression or intolerable adverse reactions. Responses were evaluated as per Lugano 2014 criteria. Adverse reactions were assessed according to Common Terminology Criteria for Adverse Events of National Cancer Institute, USA (version 4.03). Kaplan-Meier method was used for survival analysis.

·Twelve patients were included in this study with a median age of 44 years, and 9 patients were males. Among them, 6 patients received anlotinib monotherapy, and 6 patients received anlotinib combined with PD-1 monoclonal antibody therapy. Treatment-related adverse events were observed in all 12 subjects without unexpected adverse reactions. The grade 3 adverse events included hypertension (2 cases) and hyponatremia (1 case). There were 50.0% patients obtaining objective responses with 33.3% in the anlotinib monotherapy group and 66.7% in the combined treatment group. The median progression-free survival was 3.0 months and the median overall survival (OS) was 3.0 months. The median OS of the patients receiving anlotinib alone was 2.8 months, while it was 8.0 months in the patients receiving anlotinib combined with PD-1 monoclonal antibody. The median OS of the responding patients was 8.0 months, while it was 2.8 months in the non-responding patients.

·Anlotinib may be a promising drug for the treatment of refractory NKTCL, which has a potentially synergistic effect with PD-1 monoclonal antibody; the overall safety of the drug is good, and patients generally tolerate it.