A phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G05-92.

On the basis of the promising activity of cetuximab and radiation therapy for head and neck cancers, we evaluated the efficacy of this regimen followed by surgery in patients with resectable esophageal cancer. This was a phase II, open-label, single-arm, multicenter study of patients with potentially resectable esophageal cancer.Patients received two weekly doses of cetuximab followed by weekly cetuximab combined with radiation therapy for 6 weeks. After a 6- to 8-week rest, patients' primary tumor was resected. The main objective was to evaluate pathologic complete response (pCR) rate in the primary tumor after cetuximab and radiation therapy.Thirty-nine patients completed the study. Most patients were men (93%), median age was 64 years, performance status was 0 to 1 (95%), patients had a histology of adenocarcinoma (78%), and tumors were located in the esophagus (63%). Grade 3 toxicities in more than 5% of patients included dysphagia (17%), anorexia and dehydration (7%), and dyspnea, fatigue, hypernatremia (5%). Grade 5 aspiration occurred in 2% (1 patient). Four patients died, two from disease progression, one from aspiration pneumonia postsurgery, and one from septic shock. Thirty-one patients (76%) underwent esophagectomy. The pCR rate was 36.6% by intention-to-treat and 48% for patients who underwent esophagectomy. The pCR by histology was 6 of 9 (67%) for squamous cell carcinomas and 9 of 32 (28%) for adenocarcinoma. Earlier-stage disease was associated with increased pCR (IIA 70%, IIB 29%, III 28%).Cetuximab and radiation therapy results in a pCR rate that seems at least comparable with that of chemotherapy and radiation therapy. This regimen may be better tolerated than preoperative chemotherapy and radiation therapy in patients with resectable esophageal cancers.