Cetuximab with concurrent chemoradiation for esophagogastric cancer: assessment of toxicity.
OBJECTIVE
To determine the feasibility and toxicity of the addition of cetuximab with paclitaxel, carboplatin, and radiation for patients with esophagogastric cancer on a Phase II study.


METHODS
Patients with locoregional esophageal and proximal gastric cancer without distant organ metastases were eligible. All patients received cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.


RESULTS
Sixty patients were enrolled, 57 with esophageal cancer and 3 with gastric cancer. Forty-eight had adenocarcinoma and 12 had squamous cell cancer. Fourteen of 60 patients (23%) had Grade 3 dermatologic toxicity consisting of a painful, pruritic acneiform rash on the face outside of the radiation field. The rates of Grades 3 and 4 esophagitis were 12% and 3%, respectively. Three patients had Grade 3/4 cetuximab hypersensitivity reactions and were not assessable for response. Forty of 57 patients (70%) had a complete clinical response after chemoradiation.


CONCLUSIONS
Cetuximab can be safely administered with chemoradiation for esophageal cancer. Dermatologic toxicity and hypersensitivity reactions were associated with the addition of cetuximab. There was no increase in esophagitis or other radiation-enhanced toxicity.
Safran
Howard
H
Brown University Oncology Group, Providence, RI, USA. hsafran@lifespan.org
Suntharalingam
Mohan
M
Dipetrillo
Thomas
T
Ng
Thomas
T
Doyle
L Austin
LA
Krasna
Mark
M
Plette
Angela
A
Evans
Devon
D
Wanebo
Harold
H
Akerman
Paul
P
Spector
Jeremy
J
Kennedy
Nancy
N
Kennedy
Teresa
T
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D000068818:Cetuximab; D004342:Drug Hypersensitivity / Q000209:etiology*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D004941:Esophagitis / Q000139:chemically induced; D005148:Facial Dermatoses / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D017239:Paclitaxel; D000068818:Cetuximab