| 王建芳,孙彩萍,刘建江,叶万立,陈遐林.埃克替尼联合放疗治疗晚期非小细胞肺癌的随机对照研究[J].中华放射医学与防护杂志,2017,37(4):269-272,281 |
| 埃克替尼联合放疗治疗晚期非小细胞肺癌的随机对照研究 |
| Randomized controlled trial of icotinib concurrent with thoracic radiotherapy for treating advanced non-small cell lung cancer (NSCLC) |
| 投稿时间：2016-11-09 |
| DOI：10.3760/cma.j.issn.0254-5098.2017.04.006 |
| 中文关键词: 非小细胞肺癌 表皮生长因子受体 突变 埃克替尼 胸部放疗 |
| 英文关键词:Non-small cell lung cancer EGFR Mutation Icotinib Thoracic radiotherapy |
| 基金项目:浙江省卫生厅一般计划项目（2014KYB278） |
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| 中文摘要: |
| 目的 比较埃克替尼单药或联合胸部放疗治疗表皮生长因子受体（EGFR）敏感突变的Ⅳ期非小细胞肺癌的疗效及安全性。方法 共纳入83例EGFR基因敏感突变的晚期非小细胞肺癌患者，按随机数字表法分成两组。联合治疗组41例，肺部原发病灶放射治疗60~66 Gy，同步埃克替尼125 mg，3次/d，放疗结束后继续予埃克替尼维持治疗；单纯药物组42例，埃克替尼125 mg，3次/d。两组药物治疗直至疾病进展或出现不可耐受的不良反应后停止。研究的主要终点为中位无进展生存时间（mPFS）和12个月PFS率，次要终点为客观缓解率（ORR）、疾病控制率（DCR）和不良反应。结果 经过18.2个月的中位随访， 联合治疗组及单纯药物组mPFS分别为15.2个月（95%CI：12.2~17.4个月）及13.2个月（95%CI：10.8~14.9个月）（χ2=4.29，P=0.036）；1年PFS率分别为70.3%及61.2%；ORR分别为78.0%及57.1%（χ2=5.16，P=0.028）；DCR分别为95.1%及92.9%（P>0.05）。不良反应方面，常见的3~4级不良反应为皮疹，两组均为4例。联合治疗组中有10例发生1~2级放射性肺炎，15例发生1~2级放射性食管炎。结论 埃克替尼联合胸部放疗治疗EGFR敏感突变的晚期非小细胞肺癌可提高客观缓解率，延长无进展生存期，患者的不良反应耐受性良好。临床试验注册号 中国临床试验注册中心，Chi CTR-INR-16010262。 |
| 英文摘要: |
| Objective To compare the efficacy and safety of icotinib therapy alone versus icotinib combined with thoracic radiotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) patients with an activating epidermal growth factor receptor (EGFR) gene mutation.Methods A total of 83 patients with advanced NSCLC harboring an activating EGFR gene mutation was enrolled in this study. All the patients were randomly divided into 2 groups. Patients in group A (n=41) received thoracic radiotherapy (prescribed at 60-66 Gy) combined with icotinib (three times per day, 125 mg once). Patients in group B (n=42) were given icotinib therapy alone (three times per day, 125 mg once). Treatment was continued until disease progression or unacceptable toxicity or death. The primary end points were median progression-free survival (mPFS) and 12 month-PFS rate. The secondary end points included objective response rate (ORR), disease control rate (DCR) and adverse events. Results With a median follow-up of 18.2 months, mPFS was 15.2 months (95% CI: 12.2-17.4) in group A and 13.2 months (95% CI: 10.8-14.9) in group B (χ2=4.29, P=0.036). PFS rates of 12 months for group A and group B were 70.3% and 61.2%, respectively. The ORR were 78.0% vs. 57.1% (χ2=5.16, P=0.028), and the DCR were 95.1% vs. 92.9% (P>0.05) in groups A and group B, respectively. No grade 3-4 adverse events was observed in both groups except the rashes (4 cases in each group). Besides, 10 patients had grade 1-2 radiation-related pneumonitis and 15 patients suffered grade 1-2 radiation-related oesophagitis in group A.Conclusions In advanced NSCLC patients with an activating EGFR gene mutation, the combination of thoracic radiotherapy and icotinib had achieved an improvement on ORR and PFS with good tolerance. Clinical trial registration Chinese clinical trial registry, ChiCTR-INR-16010262. |
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