【摘要】 目的探讨厄洛替尼治疗Ⅳ期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效、影响因素和不良反应。方法回顾性分析2009-04-16-2012-03-16河北医科大学第四医院77例采用厄洛替尼治疗经病理学确诊的Ⅳ期NSCLC患者临床资料,剂量为150mg/d,治疗至病情进展或出现不能耐受的不良反应。其中一线治疗患者21例,接受过>1个周期化疗和(或)局部放疗患者56例。比较不同组别客观缓解率和疾病控制率。Kaplan-Meier法计算无进展生存率和总生存率并Log-rank检验,Cox回归模型进行多因素分析。结果 77例患者总体客观缓解率为55.8%(43/77),疾病控制率为66.2%(51/77),中位无疾病进展时间6.0个月,95%CI为3.693~8.31;中位生存时间9.5个月,95%CI为6.82~12.18。1年无进展生存率为31.3%,2年为14.6%,3年为7.3%。1年总生存率为39.8%,2年为11.6%,3年为5.8%。χ2评分≥70者的客观缓解率和疾病控制率分别为83.7%(41/49)和87.7%(43/49),均高于<70者的7.1%(2/28)和28.6%(8/28),χ2值分别为42.322和27.906,P值均<0.001。非吸烟者疾病控制率为80.7%(25/31),高于吸烟患者的56.5%(26/46),χ2=4.819,P=0.028。单因素分析结果显示,腺癌和卡氏评分≥70患者的无进展生存率分别高于鳞癌和卡氏评分<70患者,P值分别为0.010和<0.001;腺癌、无脑转移和卡氏评分≥70患者的总生存率分别高于鳞癌、有脑转移和卡氏评分<70患者,P值分别为0.023、0.040和<0.001。多因素分析结果显示,病理类型、卡氏评分状况和有无脑转移是疾病无进展生存的独立影响因素,P值分别为<0.001、<0.001和0.040;而卡氏评分状况是影响总生存的独立因素,P<0.001。不良反应主要是皮疹(59.7%)及腹泻(35.1%),多为Ⅰ~Ⅱ度。3例(3.9%)因Ⅲ度皮疹停药,未出现Ⅳ度药物相关不良反应。结论厄洛替尼对Ⅳ期NSCLC患者有较好的疗效和安全性,体能状况评分高和非吸烟患者能够获得较高的疾病控制率。卡式评分状况是总生存期和无进展生存期的独立影响因素,而腺癌和无脑转移患者较鳞癌和有脑转移患者能够获得较长的无进展生存时间。更多还原

【Abstract】 OBJECTIVE The aim of the retrospective study was to evaluate the efficacy in stage Ⅳ non-small cell lung cancer(NSCLC)patients treated with erlotinib,and to observe the adverse events and influencing factors.METHODS From April 16,2009 to March 16,2012,77 patients with NSCLC in StageⅣ received oral erlotinib,at a dose of 150 mg per day till disease progression or intolerable adverse events were developed,including 56 cases who had received one or more chemotherapy regiments and/or combined palliative radiotherapy and 21 cases who had never received prior treatment.The objective response rate(ORR)and disease control rate(DCR)were observed between the groups,the progression-free survival(PFS)and overall survival(OS)were calculated by Kaplan-Meier method with the use of log-rank method.Prognostic factors of the patients were analyzed with univariate and multivariate analysis in Cox regression model.RESULTS The ORR and DCR were 55.8%(43/77)and 66.2%(51/77),respectively.The median PFS was 6.0months,and the OS was 9.5months.The 1-,2-and 3-year PFS rates were 31.3%,14.60% and 7.3% respectively,and the 1-,2-and 3-yea OS rate were 39.8%,11.6%and 5.8%,respectively.The ORR and DCR in less than KPS score of 70 group were much lower than those of group which score was 70 and more(7.1% vs 83.7%,χ2=42.322,P<0.001and28.6%vs 87.7%,χ2=27.906,P<0.001,respectively).The nonsmokers had a higher DCR rate than smokers(80.7%vs56.5%,χ2=4.819,P=0.028).Univariate analysis showed that there was a higher PFS rate in adenocarcinoma group than that in squamous cell carcinoma group,and in KPS score of 70 and more group than in less than score of 70group(χ2=6.644,P=0.010,andχ2=74.878,P<0.001,respectively).Multivariate analysis showed that the KPS score,pathological type and with brain metastasis or not were the independent prognostic factors of the PFS(P<0.001,P<0.001,and P=0.040,respectively).The patients with brain metastasis,squamous cell carcinoma and less than KPS score of 70 had the poor OS time(χ2=4.238,P=0.040;χ2=5.136,P=0.023andχ2=102.689,P<0.001,respectively),only the KPS score was the independent influencing factors of the OS(P<0.001).Adverse events were generally in gradeⅠ or in gradeⅡ,including skin rash(59.7%)and diarrhea(35.1%).Three patients were intolerant of erlotinib in total because they had diarrhea of gradeⅢ.There were no gradeⅣ drug-related adverse event occurred.CONCLUSIONS Erlotinib is effective and safe for the StageⅣ NSCLC patients.The high KPS score and non-smokers groups have higher DCR rate.KPS score is the most important influencing factors for patient’s PFS and OS time.The patients with adenocarcinoma and no brain metastasis had higher PFS rate than those of squamous cell carcinoma and brain metastasis.更多还原