| General information |
| Database: | DB00782 |
| Objective: | Therapeutic agents directed against the epidermal growth factor receptor (EGFR) signaling pathway have been effective in the treatment of non small cell lung cancer (non small cell lung cancer). Cetuximab is a monoclonal antibody against the EGFR receptor with antitumor activity in non small cell lung cancer. This study evaluated the efficacy of cetuximab monotherapy after prior treatment with an oral EGFR tyrosine kinase inhibitor (TKI). |
| Authors: | Neal JW, et al |
| Title: | Cetuximab monotherapy in patients with advanced non small cell lung cancer after prior epidermal growth factor receptor tyrosine kinase inhibitor therapy. |
| Journal: | J Thorac Oncol. |
| Year: | 2010 |
| PMID: | 20975380 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | multicenter, singlearm, phase II clinical trial |
| Key Patients Feature: | Eligible patients had stage IIIB, IV, or recurrent non small cell lung cancer with progression on the oral EGFR TKIs gefitinib or erlotinib. |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | Three patients harbored activating EGFR mutations, and one of them had stable disease for nearly 6 months on cetuximab |
| Control Group Info: | single arm |
| Treatment Info: | Cetuximab was administered intravenously at 400 mg/m on day 1 and then 250 mg/m weekly until disease progression or unacceptable toxicity. |
| Primary End Point: | response rate. |
| Secondary End Point: | NA |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 0% |
| Disease Control Rate: | 0.28 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.8 months (95% confidence interval, 1.65.4 months) |
| Median OS A vs. C: | median overall survival was 7.5 months (95% confidence interval, 2.219 months). |
| Adverse Event(agent arm): | Skinrelated treatment related toxicity was the most common adverse event Serious events included interstitial lung disease, anginalike chest pain, headache, and shortness of breath/wheezing |
| Conclusions: | Cetuximab monotherapy administered after prior EGFR TKI treatment in patients with advanced non small cell lung cancer does not yield clinical responses. |