Gefitinib and radiation therapy for elderly patients with esophageal squamous cell carcinoma: Preliminary results of a phase II study.

e15034 Background: To determine the safety and efficacy of Gefitinib combined with thoracic radiotherapy for elderly patients with esophageal squamous cell carcinoma (ESCC) who are not candidates for chemoradiation therapy. Methods: Patients > 65 years with ESCC who were not eligible for platinum-based treatment received Gefitinib daily for 2 months starting on day 1 of radiotherapy [50.4 Gy days 1–28 (Mon-Fri) at 1.8 Gy per fraction]. Response was assessed by endoscopy and computed tomography. The primary end point of the study was the response rate, and the secondary end points were survival time and toxicity. Immunohistochemistry (IHC) was performed to analyze the expression of EGFR. The amplified refractory mutation system (ARMS) was performed to detect EGFR gene mutations using real-time PCR. The survival curves were calculated using the Kaplan–Meier method. Results: There were 5 complete responses, 13 partial responses who were treated with concurrent radiotherapy/Gefitinib. The overall response rat...