KRAS mutation status and toxicity of cetuximab, paclitaxel, cisplatin, and concurrent radiation in Chinese patients with locally advanced esophageal squamous cell carcinoma: An open-label, multicenter, phase II study.

e14650 Background: The most common type of esophageal or gastroesophageal-junction cancer in Western countries is adenocarcinoma; however, in China more than 90% of esophageal malignancies are of squamous cell carcinoma (SCC). Thus data are lacking on the potential benefits from the use of cetuximab for Chinese patients with esophageal SCC. We conducted this Chinese multicenter trial to determine the toxicity of the addition of cetuximab with paclitaxel, cisplatin, and concurrent radiation for patients with esophageal SCC and to determine whether KRAS status predicts response. Methods: Patients with unresectable locally advanced cervical, upper or mid-esophageal SCC without distant metastasis were eligible for this open-label phase II trial. All patients received cetuximab (400 mg/m2 day 1 before chemoradiotherapy and 250 mg/m2 q1w × 7 weeks), paclitaxel (45 mg/m2 q1w × 7 weeks) and cisplatin (20 mg/m2 q1w × 7 weeks) with 59.4 Gy of radiation. KRAS mutation status was assessed in tumor specimen at a centr...