TY - JOUR
T1 - A Phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas
T2 - Hoosier oncology group G05-92
AU - Becerra, Carlos R.
AU - Hanna, Nasser
AU - Mccollum, Andrew David
AU - Becharm, Naftali
AU - Timmerman, Robert D.
AU - Dimaio, Michael
AU - Kesler, Kenneth A.
AU - Yu, Menggang
AU - Yan, Tong
AU - Choy, Hak
N1 - Funding Information:
This study was supported by a grant from Bristol-Meyers Squibb.
PY - 2013/11
Y1 - 2013/11
N2 - INTRODUCTION:: 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. METHODS:: 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. RESULTS:: 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%). CONCLUSIONS:: 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.
AB - INTRODUCTION:: 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. METHODS:: 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. RESULTS:: 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%). CONCLUSIONS:: 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.
KW - Cetuximab
KW - Esophageal
KW - Radiation therapy
KW - Resectable
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U2 - 10.1097/JTO.0b013e3182a46c3b
DO - 10.1097/JTO.0b013e3182a46c3b
M3 - Article
C2 - 24084441
AN - SCOPUS:84886586729
SN - 1556-0864
VL - 8
SP - 1425
EP - 1429
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 11
ER -