国产吉非替尼对晚期转移性肺腺癌的疗效分析

Efficacy of Domestic Gefitinib in the Treatment of Advanced Metastatic Lung Adenocarcinoma

目的评价国产吉非替尼对晚期转移性肺腺癌患者的疗效和不良反应,并探讨其疗效的影响因素。方法选取2017年9月至2018年10月就诊于郑州大学第一附属医院的103例晚期转移性肺腺癌患者为研究对象,患者连续口服国产吉非替尼片250 mg·d-1,直至出现疾病进展或因严重不良反应不能耐受而停止给药。治疗过程中,每1~2个月复查,根据美国国家肿瘤研究所实体瘤疗效客观评价标准每1~2个月评价疗效,并统计患者的疾病无进展生存期,分析患者年龄、性别、吸烟史、美国东部肿瘤协作组评分、淋巴结转移、脑转移、骨转移、肝转移、肾上腺转移、肿瘤分期、联合化疗等与患者疾病无进展生存期的关系,评估治疗期间不良反应发生情况。结果103例晚期转移性肺腺癌患者的疾病无进展生存期为22~667 d,中位疾病无进展生存期为320 d。单因素分析结果显示,患者有无肾上腺转移、肿瘤分期早晚、有无联合化疗与国产吉非替尼治疗晚期转移性肺腺癌的疾病无进展生存期有关(P均<0.05);多因素分析结果显示,肿瘤分期为Ⅳb期及未联合化疗是国产吉非替尼治疗晚期转移性肺腺癌患者疾病无进展生存期短的独立危险因素(P均<0.05)。治疗期间26例(25.2%)患者出现Ⅰ、Ⅱ级皮疹,1例(1.0%)患者出现Ⅲ级皮疹;6例(5.8%)患者出现Ⅰ、Ⅱ级腹泻;15例(14.6%)患者出现Ⅰ、Ⅱ级恶心;11例(10.7%)患者出现Ⅰ、Ⅱ级骨髓抑制;9例(8.7%)患者出现Ⅰ、Ⅱ级肝损伤。结论患者有无肾上腺转移、肿瘤分期早晚、有无联合化疗可影响国产吉非替尼治疗晚期转移性肺腺癌患者的疾病无进展生存期,肿瘤分期为Ⅳb期和未联合化疗是导致国产吉非替尼治疗晚期转移性肺腺癌患者疾病无进展生存期缩短的独立危险因素。

Objective To evaluate the efficacy and side effects of domestic gefitinib in the treatment of patients with advanced metastatic lung adenocarcinoma,and to explore the influencing factors of treatment effect.Methods The 103 patients with advanced metastatic lung adenocarcinoma who were admitted to the First Affiliated Hospital of Zhengzhou University from September 2017 to October 2018 were selected as the study subjects.The patients continued to take domestic gefitinib tablets at 250 mg·d-1 orally until the disease progressed or they could not tolerate the side effects.During the treatment,the patients were reexamined every 1 to 2 months.The efficacy was evaluated every 1 to 2 months according to the response evaluation criteria in solid tumors of the National Cancer Institute,and the progression-free survival was counted.The relationship between age,gender,smoking history,Eastern Cooperative Oncology Group score,lymph node metastasis,brain metastasis,bone metastasis,liver metastasis,adrenal metastasis,tumor stage,chemotherapy and other clinical factors and progress-free survival period was analyzed,and the occurrence of side effects during treatment was evaluated.Results The progression-free survival of 103 patients with advanced metastatic lung adenocarcinoma was 22 to 667 days,and the median progression-free survival was 320 days.Univariate analysis showed that adrenal metastasis,tumor stage,and combination chemotherapy were associated with the progression-free survival of the advanced metastatic lung adenocarcinoma patients treated with domestic gefitinib(P<0.05).Multiple factors analysis showed thatⅣb stage and without combination chemotherapy were the independent risk factors of the progression-free survival for the advanced metastatic lung adenocarcinoma patients treated with domestic gefitinib(P<0.05).During the treatment period,the degreeⅠtoⅡrash was observed in the 26 patients(25.2%),the degreeⅢrash was observed in the 1 patient(1.0%);the degreeⅠtoⅡdiarrhea occurred in the 6 patients(5.8%);the degreeⅠtoⅡnausea was observed in the 15 patients(14.6%);the degreeⅠtoⅡmyelosuppression was observed in the 11 patients(10.7%);the degreeⅠtoⅡliver injury was observed in the 9 patients(8.7%).Conclusion The presence of adrenal metastasis,tumor stage,or combined chemotherapy can affect the progression-free survival of the advanced metastatic lung adenocarcinoma patients treated with domestic gefitinib,Ⅳb stage and without combined chemotherapy are the independent risk factors of the progression-free survival for the advanced metastatic lung adenocarcinoma patients treated with domestic gefitinib.