| General information |
| Database: | DB00420 |
| Objective: | They carried out a multiinstitutionalphase II study of cetuximab, a monoclonal antibody against EGFR, in patients with unresectable or metastatic esophageal or gastric adenocarcinoma. |
| Authors: | Chan JA, et al |
| Title: | A multicenterphase II trial of singleagent cetuximab in advanced esophageal and gastric adenocarcinoma. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 21217058 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer or gastric cancer |
| Cancer Subtype: | advanced esophageal or gastric adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | multicenterphase II trial |
| Key Patients Feature: | The study population consisted of patients with histologically confirmedunresectable or metastatic esophageal or gastric adenocarcinoma who hadexperienced treatment failure with one to two prior chemotherapyregimens |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with weekly cetuximab, at an initial dose of 400 mg/m(2) follotheyd by weekly infusions at 250 mg/m(2). Patients were follotheyd for toxicity, treatment response, and survival. |
| Primary End Point: | the response rate. . |
| Secondary End Point: | PFS and overall survival (OS), toxic effects |
| Patients Number: | 35 |
| Trial Results |
| DLT_MTD: | the most commonly reported adverse events of allgrades were acnelike rash (77%), fatigue (63%), anemia(49%), hypomagnesemia (40%), anorexia (40%), and nausea(40%). Grade 3 toxicity was uncommon, and no grade 4adverse events were noted |
| Objective Response Rate: | One (3%) partial treatment response was noted. Two (6%) patients had stable disease after 2 months oftreatment. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.6 months |
| Median OS A vs. C: | 3.1 months. |
| Adverse Event(agent arm): | Overall, treatment with cetuximab was well tolerated. Across all grades of toxicity, the most commonly reported adverse events of all grades were acnelike rash (77%), fatigue (63%), anemia (49%), hypomagnesemia (40%), anorexia (40%), and nausea (40%). Grade 3 toxicity was uncommon, and no grade 4 adverse events were noted. Fatigue was the most common grade 3 treatmentrelated toxicity, observed in 6% of patients. No patients required dose reduction of cetuximab for treatment related toxicity. One patient experienced a delay in treatment due to grade 3 acneiform skin rash but was able to continue treatment without dose modification. |
| Conclusions: | 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. |