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 / 中华放射肿瘤学杂志

ABSTRACT

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.