IMRT联合易瑞沙对不能手术不能同步放化疗局部晚期NSCLCⅡ期临床研究初步结果

IMRT combined with Iressa for patients with locally advanced non-small cell lung cancer unsuitable for surgery or concurrent chemoradiotherapy：the preliminary results of a phase Ⅱ clinical trial

目的 观察放疗联合易瑞沙治疗不能手术且不能行同步放化疗的局部晚期非小细胞肺癌患者的客观有效率、生存和安全性。方法 选取不能手术且不能行同步放化疗的局部晚期NSCLC患者,接受胸部IMRT,同期易瑞沙250 mg 1 次/d。结果 2014—2017年入组30例,可分析29例。疗后1个月疗效评价CR、PR、SD、PD分别0、21、6、2例,疾病控制率（CR＋PR＋SD）为93%,客观有效率（CR＋PR）为72%。中位随访25个月,死亡14例,存活15例;23例患者出现疾病进展,其中局部进展18例,远处转移14例。全组中位生存时间 26个月,中位PFS 11个月,1、2年OS和PFS分别为79%和44%、55%和18%。单因素分析显示吸烟史、分期对OS有影响（P=0.035、0.031）,分期、原发灶直径、GTV和PTV对PFS有影响（P=0.000、0.016、0.039、0.030）;多因素分析显示分期和PTV体积为PFS的独立预后因素（P=0.000、0.012）。3级急性不良反应共2例,2级急性放射性肺炎7例。结论 对于不能手术且不能行同步放化疗的局部晚期非小细胞肺癌,放疗联合易瑞沙的治疗,客观有效率较高,患者耐受良好,远期疗效有待进一步观察。

Objective To observe the objective response rate,survival and safety of radiotherapy combined with Iressa for patients with locally advanced non-small cell lung cancer （NSCLC） unsuitable for surgery or concurrent chemoradiotherapy. Methods The patients with locally advanced NSCLC unsuitable for surgery or concurrent chemoradiotherapy were recruited and received thoracic intensity-modulated radiotherapy （IMRT） combined with Iressa 250 mg daily. Results A total of 30 patients were enrolled between July 2014 and March 2017. Twenty-nine patients were analyzed. At 1 month after radiotherapy,the complete response （CR） was 0,partial response （PR） was 21（72%）,stable disease （SD） was 6（21%）,progressive disease （PD） was 2（7%）,the disease control rate （CR＋PR＋SD） was 93%,and the objective response rate was 72%. The median follow-up time was 25 months. Fourteen （48%） patients died,and 15（52%） survived. Twenty-three （79%） patients obtained PD including local progression in 18（62%） and distant metastasis in 14（48%）. The median survival time （MST） was 26 months and the median PFS was 11 months. The 1-year OS and PFS were 79% and 44%,and the 2-year OS and PFS were 55% and 18%. Univariate analysis demonstrated that smoking history and disease stage were influencing factors for OS （P=0.035,0.031）. Moreover,disease stage,the primary tumor diameter,the volume of GTV and PTV were influencing factors for PFS （P=0.000,0.016,0.039,0.030）. Multivariable analysis revealed that disease stage and the volume of PTV were independent prognostic factors for PFS （P=0.000,0.012）.Two patients （7%） developed grade 3 acute adverse events and 7（24%） experienced grade 2 acute irradiation pneumonitis. Conclusions For patients with locally advanced NSCLC unsuitable for surgery or concurrent chemoradiotherapy,IMRT combined with Iressa yields high objective response rate and well tolerance. The long-term clinical efficacy remains to be validated.