| General information |
| Database: | DB00719 |
| Objective: | They investigated in the firstline setting our previous finding that patients with chemorefractory KRAS G13Dmutated metastatic colorectal cancer (mCRC) benefit from cetuximab treatment. |
| Authors: | Tejpar S, et al |
| Title: | Association of KRAS G13D tumor mutations with outcome in patients with metastatic colorectal cancer treated with firstline chemotherapy with or without cetuximab. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22734028 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | firstline chemotherapy with or without cetuximab |
| Study Type: | retrospective study |
| Key Patients Feature: | patients with chemorefractory KRAS G13Dmutated metastatic colorectal cancer (mCRC) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | cetuximab plus chemotherapy VS chemotherapy alone |
| Treatment Info: | retrospectively revietheyd data from previous clinical trial |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 533 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Within KRAS mutation subgroups, cetuximab plus chemotherapy versus chemotherapy alone significantly improved PFS (median, 7.4 v6.0 months; hazard ratio [HR], 0.47; P= .039) |
| Median OS A vs. C: | 15.4 v 14.7 months; HR, 0.89; P=0.68) in patients with G13Dmutant tumors. |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of cetuximab to firstline chemotherapy seems to benefit patients with KRAS G13Dmutant tumors. Relative treatment effects they were similar to those in patients with KRAS wildtype tumors but with lotheyr absolute values. |