| General information |
| Database: | DB00431 |
| Objective: | Overexpression of epidermal growth factor receptor in esophageal cancer is associated with poor prognosis. The present study was conducted to evaluate safety and preliminary efficacy of nimotuzumab, a humanized antiEGFR antibody in combination with radiation and chemotherapy in advanced esophageal tumours. |
| Authors: | RamosSuzarte M, et al |
| Title: | Treatment of malignant, nonresectable, epithelial origin esophageal tumours with the humanized antiepidermal growth factor antibody nimotuzumab combined with radiation therapy and chemotherapy. |
| Journal: | Cancer Biol Ther. |
| Year: | 2012 |
| PMID: | 22555809 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | malignant, nonresectable, epithelial origin esophageal tumours |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | nimotuzumab combined with radiation therapy and chemotherapy |
| Study Type: | not a clinical trial |
| Key Patients Feature: | patients with nonresectable, epithelial origin esophageal cancer |
| Biomarker: | Epidermal growth factor receptor expression, KRAS mutation status |
| Biomark Analysis: | Response and disease control rate were higher in patients with EGFR overexpressing tumors. |
| Control Group Info: | single arm |
| Treatment Info: | a phase II clinical trial was conducted, where patients received cisplatin, 5fluorouracil, and radiotherapy, either alone or combined with six weekly infusions of nimotuzumab at the dose of 200 mg. |
| Primary End Point: | Safety. |
| Secondary End Point: | antitumoral objective response rate. Epidermal growth factor receptor expression, KRAS mutation status and antiidiotypic response were also evaluated. |
| Patients Number: | 63 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rate was 47.8 % (nimotuzumab group) and 15.4 % (control group). Disease control rate was 60.9 % (nimotuzumab group) and 26.9 % (control group). Response and disease control rate were higher in patients with EGFR overexpressing tumors. |
| Disease Control Rate: | 60.9% (nimotuzumab group) and 26.9% (control group). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | All nimotuzumab related adverse events were categorized as grade 1 or 2 (nine) and consisted on fever (11.1%), headache (22.2%), high blood pleasure (11.1%), nausea (11.1%), phlebitis (22.2%), deglution pain (22.2%). None of the nimotuzumab treated patients had allergic reactions or skin rash. In summary, toxicity of chemoradiotherapy was not exacerbated by the addition of the humanized antiEGFR mAb. |
| Conclusions: | Nimotuzumab plus chemoradiotherapy was safe and provided statistically significant objective response. Aphase III in patients with similar characteristics will be launched. |