| 摘要: |
| 目的 观察和评价表皮细胞生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）类药物盐酸埃克替尼单药治疗晚期非小细胞肺癌（NSCLC）的疗效及毒副反应，并分析影响疗效的相关因素。方法分析72例ⅢB期及Ⅳ期NSCLC患者，所有患者均口服盐酸埃克替尼125mg，3次/d，分析患者临床特点及其与客观有效率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）的关系，以及症状缓解、毒副反应情况。结果72例患者中有4例因毒副反应或其他原因而停药。余下68例患者中，部分缓解30例（44.1%），疾病稳定19例（27.9%），疾病进展19例（27.9%）。ORR为44.1%，DCR为72.0%，中位PFS6.0个月。ORR及DCR在不同性别、不同美国东部肿瘤协作组（ECOG）评分、不同病理类型、不同EGFR突变状态及不同皮疹状态之间的比较差异均有统计学意义（P＜0.05或0.01）。Kaplan-Meier法生存分析显示PFS在不同TNM分期、病理类型、EGFR突变状态以及皮疹状态患者间的比较差异有统计学意义（P＜0.05）。全组有42例（61.8%）患者在治疗后有不同程度的症状缓解。治疗相关毒副反应主要为皮疹34例（50.0%），腹泻16例（23.5%），其他毒副反应包括转氨酶升高、食欲不振、乏力、恶心、呕吐、头晕等。结论盐酸埃克替尼单药治疗晚期NSCLC疗效肯定，对于EGFR突变患者有效率更高，治疗相关毒副反应较轻，患者耐受性好，为晚期NSCLC患者治疗带来新希望。 |
| 关键词: 盐酸埃克替尼 非小细胞肺癌 临床疗效 毒副反应 |
| DOI： |
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| Icotinib hydrochloride monotherapy for patients with advanced non-small cell lung cancer |
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PANG Linrong, CHEN Jun, HUANG Jia, XU Caihong, LI hui, ZHENG Hongyu
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Yinzhou People's Hospital
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| Abstract: |
| Objective To evaluate the efficacy and toxicity of icotinib hydrochloride monotherapy for patients with ad- vanced non-small cell lung cancer (NSCLC). Methods Seventy two patients with ⅢB or IV NSCLC were enrolled in this study from September 2012 to September 2013. All patients received Icotinib 125mg t.i.d. The objective response rate (ORR), disease control rate (DCR), progression free survival (PFS)and their influencing factors were analyzed. The symptoms relief, or adverse events were also analyzed. Results Among 72 patients,4 dropped from study due to side events or other reason. Among 68 evaluable patients, 30 (44.1%) had partial response, 19 (27.9%) had stable disease and 19 (27.9%) had progressive disease. The objective response rate was 44.1%, the disease control rate was 72.0%, and the median progression free survival was 6 months. The ORR and DCR were correlated with gender,ECOG scores,pathological type, EGFR mutation status and rash (P＜ 0.05). Kaplane-Meier survival analysis showed that PFS was significantly correlated to TNM stage, pathological type, EGFR mutation status and rash(P＜0.05). Forty two patients(61.8%) had symptom relief after treatment. Skin rash was the most com-
mon drug-related adverse event, which occurred in 34 patients(50.0%), including grade Ⅰ to Ⅱ in 31 and grade Ⅲ to Ⅳ in 3. Diarrhea occurred in 16 patients (23.5%), including grade Ⅰ to Ⅱ in 15 and grade Ⅲ to Ⅳ in 1. Other toxic reactions included elevated transaminase,loss of appetite,fatigue, nausea and vomiting and dizzy. Conclusion Monotherapy with icotinib hy- drochloride is effective and tolerable for patients with advanced NSCLC, especially for those with EGFR mutation. |
| Key words: Icotinib hydrochloride Non-small cell lung cancer Clinical effect Adverse effect |
