Background: The efficacy of second or third-line chemotherapy in advanced non-small cell lung cancer (NSCLC) patients is low. The use of targeted drugs brings survival benefit for some patients. Apatinib, as a novel small molecule antiangiogenic drug, has demonstrated satisfactory anticancer activity across a broad range of malignancies. The aim of this study is to evaluate the efficacy and safety of apatinib in patients with advanced NSCLC after first-line treatment failure.
Methods: A retrospective study of 128 patients was conducted to evaluate the safety, short-term efficacy and survival status with different regimens. Kaplan-Meier method and Cox regression model were used for analysis.
Results: Compared with chemotherapy alone, the median progression free survival (PFS) in apatinib monotherapy, chemotherapy alone and apatinib combined with chemotherapy were 3.0 (P=0.381), 3.7 and 6.0 months (P<0.001), respectively. The median overall survival (OS) were 6.0 (P=0.494), 6.5 and 9.0 months (P=0.001), respectively. The incidence of adverse events in grades 3-4 were 18.5%, 15.8% and 16.0%, respectively (P=0.947). Different treatment regimens (P=0.018) and performance status (PS)(P<0.001) were the independent factors of PFS. The smoking history (P=0.014), treatment regimens (P=0.002) and PS (P<0.001) were independent influencing factors of OS.
Conclusions: Apatinib has a good security. After first-line treatment failure of lung cancer, chemotherapy combined with apatinib in second or third-line is beneficial in PFS and OS when compared with chemotherapy alone. But when making comparison between apatinib monotherapy and chemotherapy alone, there is no significant difference in PFS and OS. Patients who never smoke or has a better PS or use combination therapy have longer survival time. .
背景与目的 晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）的二线、三线化疗有效率较低，靶向药物的应用为部分患者带来生存获益。阿帕替尼是一种新型小分子抗血管生成药物，在多种恶性肿瘤治疗中展现出令人满意的抗癌活性。本研究旨在评价阿帕替尼用于一线治疗进展后晚期非鳞NSCLC的安全性和疗效。方法 回顾性分析128例晚期非鳞NSCLC不同治疗组患者的疗效和生存情况，用Kaplan-Meier法和Cox模型进行分析。结果 以单纯化疗组为对照，阿帕替尼单药组、单纯化疗组和阿帕替尼联合化疗组的中位无进展生存期（progression free survival, PFS）分别为3.0个月（P=0.381）、3.7个月和6.0个月（P<0.001），中位总生存期（overall survival, OS）分别为6.0个月（P=0.494）、6.5个月和9.0个月（P=0.001）。3级-4级不良反应发生率分别为18.5%、15.8%和16.0%（P=0.947）。治疗方案（P=0.018）及体能状态（performance status, PS）（P<0.001）是PFS的独立影响因素，吸烟史（P=0.014）、治疗方案（P=0.002）和PS（P<0.001）是OS的独立影响因素。结论 阿帕替尼安全性高，肺癌一线治疗失败后，二线或三线化疗联合阿帕替尼，与单纯化疗相比，患者有PFS和OS获益，阿帕替尼单药与单纯化疗组间PFS和OS无明显差异；无吸烟史、PS 0分-1分和联合治疗的患者预后更好。.
Keywords: Apatinib; Efficacy; Lung neoplasms; Safety; Survival analysis.