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目的 探讨多西他赛联合阿帕替尼二线治疗晚期肺腺癌的疗效及安全性.方法 晚期肺腺癌患者60例,随机分为联用组(n = 29)和单药组(n = 31).联用组给予多西他赛(60mg·m-2,静脉滴注,第1日)联合阿帕替尼(500mg·d-1,第1日至第21日,21d为一个周期)治疗,单药组给予多西他赛(给药方式同前)单药治疗.所有患者用药直至疾病进展或不良反应不可耐受.分析比较两组的总缓解率(ORR)、疾病控制率(DCR)、不良反应发生率和无进展生存期(PFS).结果 中位随访时间10.8个月,联用组和单药组的ORR分别为21％和13％,两组相比无显著差异(P=0.419).联用组和单药组DCR分别为66％和29％,两组相比有显著差异(P = 0.005).联用组最常见的Ⅲ ～ Ⅳ级不良反应为粒细胞减少(24％),与单药组(19％)相比差异无显著意义(P = 0.701).联用组和单药组的中位PFS 分别为4.7个月(95％CI:3.4～5.9)和2.6个月(95％CI:1.8 ～ 3.5),两组相比有显著差异(P=0.009).结论 多西他赛联合阿帕替尼二线治疗晚期肺腺癌疗效显著,不良反应可控.“,”AIM To investigate the efficacy and safety of docetaxel combined with apatinib as a second-line treatment for advanced lung adenocarcinoma. METHODS Sixty patients with advanced lung adenocarcinoma were randomly divided into combination group (n = 29) and single drug group (n = 31). The combination group was treated with docetaxel (60 mg·m-2, ivgtt, the first day) combined with apatinib (500 mg·d-1, the first day to the 21st day, 21 d for a period). The single drug group was treated with docetaxel (dosing method as the former) alone. All patients were treated until disease progression or adverse reactions can't tolerate. The overall response rate (ORR), disease control rate (DCR), incidence of adverse reactions, and progression-free survival (PFS) were analyzed. RESULTS The median follow-up time was 10.8 months. The ORR of combination group and single drug group were 21％ and 13％, respectively. There was no significant difference between the two groups (P = 0.419). The DCR of the two groups were 66％ and 29％ respectively, with significant difference (P = 0.005). The most common grade Ⅲ ～ Ⅳ adverse reaction in the combination group were neutropenia (24％ ), which showed no significant difference compared with the single drug group (19％, P=0.701). The median PFS were 4. 7 months (95％ CI: 3. 4-5. 9) and 2. 6 months (95％ CI: 1. 8-3. 5) in combination group and single drug group, with significant difference between the two groups (P = 0.009). CONCLUSION Docetaxel combined with apatinib as a second-line treatment for advanced lung adenocarcinoma is effective and the adverse reactions can be controlled.