局部晚期非小细胞肺癌盐酸埃克替尼联合放疗及微波热疗临床观察

Clinical observation of icotinib hydrochloride combined with radiotherapy and microwave hyperthermia for patients with advanced non-small cell lung cancer

目的表皮生长因子受体络氨酸激酶抑制剂在非小细胞肺癌个性化治疗中的应用受到广泛关注,但目前盐酸埃克替尼联合放疗及微波热疗治疗局部晚期非小细胞肺癌的疗效尚未见报道。本研究旨在对比分析盐酸埃克替尼联合放疗和微波热疗与单纯放疗联合微波热疗治疗晚期非小细胞肺癌疗效及毒副作用。方法选取2013-04-01-2015-03-31青岛市胶州中心医院放疗科收治的36例局部晚期非小细胞肺癌患者作为研究对象。年龄46~69岁,中位年龄56岁。根据EGFR基因突变情况分组,试验组17例,男9例,女8例;对照组19例,男10例,女9例。试验组患者行胸部三维适形放疗DT:50~60Gy,放疗期间联合微波热疗及盐酸埃克替尼(凯美纳),125mg,口服,3次/d。对照组患者进行单纯放疗联合微波热疗。比较两组患者近期疗效及毒副作用。治疗结束后第1、3、6和12个月评价疗效。结果第1个月试验组和对照组PR分别为58.8%和52.6%(χ~2=0.139 3,P=0.709 0),SD分别为41.2%和47.4%(χ~2=0.139 3,P=0.709 0)。第3个月,试验组和对照组PR分别为64.7%和36.8%,(χ~2=3.950 6,P=0.046 9),SD分别为35.3%和26.3%(χ~2=2.184 4,P=0.044 3),PD分别为0和26.3%(χ~2=5.195 2,P=0.022 6),DCR分别为100.0%和63.2%(χ~2=7.775 0,P=0.053),试验组与对照组相比差异均有统计学意义。12个月时试验组部分缓解率(PR)为58.8%,疾病稳定率(SD)为41.2%,无疾病进展(PD);对照组PR为31.6%,SD为47.4%,PD为21.0%。试验组从治疗结束到症状缓解的时间明显少于对照组,P=0.014。试验组中放射性肺炎的发生率为17.6%,对照组为31.6%,对照组放射性肺炎的发生于率高于试验组,P=0.034。结论盐酸埃克替尼联合放疗及微波热疗治疗局部晚期非小细胞肺癌近期疗效优于行单纯放疗联合微波热疗的患者,毒副作用轻。

OBJECTIVE Epidermal growth factor receptor tyrosine kinase inhibitor is widely researched in Nonsmall cell lung cancer （NSCLC） personalized treatment. However,no data have been put forward on the efficacy and toxicity of icotinib hydrochloride combined with radiotherapy and microwave hyperthermia. The study aimed to investigate the efficacy and toxicity of icotinib hydrochloride combined with radiotherapy and microwave hyperthermia in the treat ment of patients with NSCLC. METHODS In total,36 patients aged 46 69 （median 56） in Qingdao Jiaozhou Central Hospital from April 1,2013 to March 31,2015 were enrolled in the study. According to the mutation of gene,17 cases including nine male and eight female were included in experimental group, and patients in the group received three-dimensional conformal radiotherapy combined with microwave hyperthermia and icotinib hydrochloride. The prescription dose was 50-60 Gy and oral icotinib hydrochloride 125 mg,three times per day. A total of 19 cases including ten male and nine female were included in control group,and the patients in the group received only three-dimensional conformal radiotherapy. Two groups were compared the efficacy and toxicity. After treatment, the efficacy for the patients were evaluated at the first month,three months, six months,and twelve months. RESULTS Partial response （PR） rate in the experimental group was 58.8%. Stable disease （SD） rate in the experimental group was 41.2%. No patients in experiment group underwent disease progress. In addition,PR rate in the control group was 31.6%. In the first month,no significant difference was observed on PR with 58.8% in experiment group and 52.6% in control group （χ^2=0. 139 3,P=0. 709 0） ,SD with 41.2% in experiment group and 47.4% in control group （χ^2 =0. 139 3,P=0. 709 0） ,PD with 0 in experiment group and 0 in control group. From the third month,significant difference was observed on PR with 64.7% in experiment group and 36.8% in control group （χ^=3. 950 6,P=0. 046 9）,SD with 35.3% in experiment group and 26.3% in control group （χ^2 =2. 184 4,P=0. 044 3） ,PD with 0 in experiment group and 26.3% in control group （χ^2 =5. 195 2,P=0. 022 6）, DCR with 100.0% in experiment group and 63.2% in control group （χ^2 =7. 775 0,P=0. 053）. The time from the end of the treatment to symptom alleviating in the experimental group was significantly shorter than that of control group （P= 0. 014）. Radiation pneumonia rate in the experimental group was 17. 6%, and radiation pneumonia rate in the control group was 31.6%. Radiation pneumonia rate in the control group was higher than that of experimental group （P= 0. 034）. CONCLUSIONS Compared with patients without drug treatment, the efficacy a of icotinib hydrochloride com- bined with radiotherapy and microwave hyperthermia is effective and tolerable for patients with advanced NSCLC.