Cetuximab plus chemoradiation with cisplatin and 5-fluorouracil (5-FU) in locally advanced unresectable esophageal squamous cell carcinoma.

Abstract

e14548^ Background: Cisplatin and 5-FU combined with radiation is standard for locally-advanced esophageal squamous cell carcinoma. Cetuximab has shown synergism with cisplatin and radiation. This study was aimed to evaluate the efficacy and safety of the addition of cetuximab to chemoradiation. Methods: Patients with unresectable stage III-IVa squamous cell carcinoma of the esophagus were enrolled and received 2 cycles of cisplatin (80 mg/m2 every 3 weeks) and cetuximab (400 mg/m2 then 250 mg/m2 weekly for 7 weeks) plus radiation 50 Gy (2Gy/d x 25 fractions), followed by 4 cycles of cisplatin and 5-FU (800 mg/m2/d for 5 days). Tumor assessment was performed every 6 weeks (RECIST and endoscopic ultrasonography). Results: From January to Decmber 2010, 20 patients were enrolled. Patients characteristics were: female/male 2/18 and median age 62 (44-78). Overall response rate was achieved in 12 patients (80%), 2 patients (13.3%) had stable disease, and 1 patient (6.7%) had disease progression (5 patients were not evaluable). Major treatment-related grade 3-4 toxicities were anemia (25%), renal impairment (20%), hyponatremia (20%), neutropenia (15%), fatigue (15%), febrile neutropenia (10%), diarrhea (10%), vomiting (5%), and esophagitis (5%). Conclusions: Cetuximab added to chemoradiotherapy with cisplatin and 5-FU is active and has an acceptable toxicity profile in patients with locally-advanced unresectable esophageal squamous cell carcinoma. Major toxicities are hematologic and metabolic disturbances, but mostly not severe and manageable.