| General information |
| Database: | DB00414 |
| Objective: | Cetuximab can reverse chemotherapy resistance in colorectal cancer. This study evaluated the efficacy and safety of the combination of docetaxel and cetuximab as a secondline treatment in docetaxelrefractory oesophagogastric cancer. |
| Authors: | Tebbutt NC, et al |
| Title: | Docetaxel plus cetuximab as secondline treatment for docetaxelrefractory oesophagogastric cancer: the AGITG ATTAX2 trial. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23412099 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | advanced oesophagogastric cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Docetaxel plus cetuximab |
| Study Type: | nonrandomised, phase II, openlabel, multicentre study |
| Key Patients Feature: | The ATTAX2 study was available for patients who hadparticipated in the ATTAX study, receiving prior weekly docetaxel(Tebbutt et al, 2010) and who progressed either during or within6 months of docetaxelbased chemotherapy according to theResponse Evaluation Criteria in Solid Tumours (RECIST)version 1.0 |
| Biomarker: | KRAS, BRAF or PIK3CA mutations |
| Biomark Analysis: | No KRAS, BRAF or PIK3CA mutations were observed. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received docetaxel 30 mg m(2) on days 1 and 8, every 3 weeks and cetuximab 400 mg m(2) on day 1, then 250 mg m(2) weekly. Biomarker mutation analysis was performed. |
| Primary End Point: | response rate. |
| Secondary End Point: | overall survival (OS), progression free survival (PFS), treatmentrelated toxicity, diseaseassociated symptoms, and quality of life. |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Response rates were PR 6% (95% CI 219%), s.d. 43% (95% CI 2859%) |
| Disease Control Rate: | 0.49 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS was 2.1 months |
| Median OS A vs. C: | median OS was 5.4 months |
| Adverse Event(agent arm): | Main grade 3/4 toxicities were febrile neutropenia, anorexia, nausea, diarrhoea, stomatitis, and acneiform rash. |
| Conclusions: | Cetuximab and docetaxel achieve modest responses rates, but maintain comparable survival times to other salvage regimens with low rates of toxicity. |