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 I clinical trial

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. (authors)