Wenrui Jiang1*, Xing Tang2*, Yuan Fang1, Shuo Wu1, Fang Yang3
1Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Xian, China.
2Department of Radiology, Xijing Hospital, Xian, China.
3Department of Neurology, Xijing Hospital, Xian, China.
*These authors contributed equally to this work.
Summary
Purpose: To evaluate the efficacy and safety of anlotinib in the third-line treatment of advanced non-small cell lung cancer (NSCLC) and assess its effect on the patient quality of life.
Methods: The patients, who were pathologically diagnosed with advanced (stage IIIB/IV) NSCLC and had been treated with at least first-line and second-line systemic chemotherapy, admitted to and treated in the hospital were selected and randomly assigned into the anlotinib group and the control group (1:1). The patients in the two groups took orally 12 mg anlotinib and placebo, respectively, once a day for 14 consecutive days, with 21 d as 1 cycle, until disease progressed or intolerable adverse events occurred. The clinical efficacy, incidence rate of adverse events and quality-of-life score were recorded. In addition, patients were followed up, and their survival was recorded.
Results: The objective response rate (ORR) and disease control rate (DCR) were 12.5% (6/48) and 68.8% (33/48) in the anlotinib group and 0% and 31.3% (15/48) in the control group, respectively, significantly better in the anlotinib group than those in the control group (p=0.011, p<0.001). Through the Common Terminology Criteria Adverse Events (CTCAE) evaluation, the common adverse reactions observed in patients in the anlotinib group were mostly of grade I-II, and grade III-IV adverse reactions included hypertension, hand-foot syndrome, thyroid dysfunction, oral mucositis, hemoptysis, and fatigue. Compared with those before treatment, the scores of physical function, emotional function, general health status and fatigue in the Quality of Life Questionnaire Core 30 (QLQ-C30) scale were significantly increased (p<0.001, p=0.044, p=0.002, p=0.034), whereas the scores of pain and dyspnea significantly declined (p=0.039, p=0.011). In the Quality of Life Questionnaire-Lung Cancer 13 (QLQLC13) scale, the scores of cough, shortness of breath, and chest pain were significantly lower than those before treatment, implying relieved symptoms after treatment, while the scores of oral pain and pricking in hands and feet were higher than those before treatment (p<0.05). Based on the results of follow-up, the 1-year overall survival (OS) and progression-free survival (PFS) were 54.2% (26/48) and 4.2% (2/48) in the anlotinib group and 39.6% (19/48) and 0% in the control group, respectively, showing no statistically significant differences between the two groups (p=0.469, p=0.068).
Conclusions: Anlotinib is safe and effective in the third-line treatment of advanced NSCLC, which is able to significantly improve the quality of life of patients.
Key words: Anlotinib, non-small cell lung cancer, third-line treatment, efficacy.
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