Radiotherapy combined with gefitinib for patients with locally advanced non-small cell lung cancer who are unfit for surgery or concurrent chemoradiotherapy: A phase Ⅱ clinical trial
Abstract Background: The objectives of this study were to determine the objective effective response rate, survival, and safety of radiotherapy combined with gefitinib in patients with locally advanced non-small cell lung cancer (NSCLC) who were unfit for surgery or concurrent chemoradiotherapy.Methods: The patients with the locally advanced NSCLC who were unfit to receive surgery or concurrent chemoradiotherapy, received thoracic intensity-modulated radiotherapy (IMRT) combined with gefitinib 250 mg daily.Results: Twenty-nine patients were enrolled between July 2014 and March 2017. Of the 29 patients, 21 (72.4%) experienced a partial response, 6 (20.7%) had stable disease, and 2 (6.9%) experienced progression of disease. The objective response rate was 72.4%, and the disease control rate was 93.1%. The median follow-up time was 51 months. The disease progression showed in 26 (89.7%) patients, including local progression in 20 (69.0%) and distant metastasis in 16 (55.2%). The median survival time (MST) and progression-free survival time (PFS) were 26 and 11 months, respectively. The 3-, 4-, 5-year survival rates were 37.6%, 29%, and 29%, respectively. The PFS rates were 17.2%, 9.2%, and 9.2%. Two patients developed grade 3 acute adverse events, and two patients developed grade 2 acute irradiation pneumonitis.Conclusions: For patients with locally advanced NSCLC who are not eligible for surgery or concurrent chemoradiotherapy, IMRT combined with gefitinib can improve the objective effective rate and is generally well-tolerated.