| General information |
| Database: | DB00278 |
| Objective: | On the basis of the promising activity of cetuximab and radiation therapy for head and neck cancers, they evaluated the efficacy of this regimen followed by surgery in patients with resectable esophageal cancer. This was a phase II, openlabel, singlearm, multicenter study of patients with potentially resectable esophageal cancer. |
| Authors: | Becerra CR, et al |
| Title: | a phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G0592. |
| Journal: | J Thorac Oncol. |
| Year: | 2013 |
| PMID: | 24084441 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | surgically resectable esophageal and GE junction carcinomas |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | cetuximab+ radiation therapy |
| Study Type: | a phase II, openlabel, singlearm, multicenter study |
| Key Patients Feature: | age more than 18 years; ECOG performance status of 0 to 2; pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus or GE junction; clinical stages IIA, IIB, III, or IVA with celiac node involvement; |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received two weekly doses of cetuximab followed by weekly cetuximab combined with radiation therapy for 6 weeks. After a 6 to 8week rest, patients' primary tumor was resected. |
| Primary End Point: | the pathologic complete response (pCR) rate. |
| Secondary End Point: | the clinical complete and partial response rates, and overall toxicities. |
| Patients Number: | 39 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The pCR rate was 36.6% by intentiontotreat. The pCR by histology was 6 of 9 (67%) for squamous cell carcinomas and 9 of 32 (28%) for adenocarcinoma. Earlierstage disease was associated with increased pCR (IIA 70%, IIB 29%, III 28%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Four patients died, two from disease progression, one from aspiration pneumonia postsurgery, and one from septic shock. |
| Adverse Event(agent arm): | 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). |
| 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. |