A multicenter phase II trial of single-agent cetuximab in advanced esophageal and gastric adenocarcinoma

作者：Chan J A^*; Blaszkowsky L S; Enzinger P C; Ryan D P; Abrams T A; Zhu A X; Temel J S; Schrag D; Bhargava P; Meyerhardt J A; Wolpin B M; Fidias P; Zheng H; Florio S; Regan E; Fuchs C S

来源：Annals of Oncology, 2011, 22(6): 1367-1373.

DOI：10.1093/annonc/mdq604

• cetuximab
• esophageal adenocarcinoma
• gastric adenocarcinoma

Background: Epidermal growth factor receptor (EGFR) is overexpressed in a significant proportion of esophageal and gastric carcinomas. Although previous studies have examined tyrosine kinase inhibitors of EGFR, there remains limited data regarding the role of EGFR-directed monoclonal antibody therapy in these malignancies. We carried out a multi-institutional phase II study of cetuximab, a monoclonal antibody against EGFR, in patients with unresectable or metastatic esophageal or gastric adenocarcinoma.
Patients and Methods: Thirty-five patients with previously treated metastatic esophageal or gastric adenocarcinoma were treated with weekly cetuximab, at an initial dose of 400 mg/m(2) followed by weekly infusions at 250 mg/m(2). Patients were followed for toxicity, treatment response, and survival.
Results: Treatment with cetuximab was well tolerated; no patients were taken off study due to drug-related adverse events. One (3%) partial treatment response was noted. Two (6%) patients had stable disease after 2 months of treatment. Median progression-free survival and overall survival were 1.6 and 3.1 months, respectively.
Conclusion: Although well tolerated, cetuximab administered as a single agent had minimal clinical activity in patients with metastatic esophageal and gastric adenocarcinoma. Ongoing studies of EGFR inhibitors in combination with other agents may define a role for these agents in the treatment of esophageal and gastric cancer.

• 出版日期2011-6