| General information |
| Database: | DB00032 |
| Objective: | a phase 3 study demonstrated that panitumumab, a human monoclonal antiepidermal growth factor receptor antibody, significantly prolonged progression free survival versus best supportive care (BSC) in patients with chemorefractory metastatic colorectal cancer. |
| Authors: | Van Cutsem E, et al |
| Title: | An openlabel, singlearm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. |
| Journal: | Ann Oncol |
| Year: | 2008 |
| PMID: | 17785764 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | An openlabel, singlearm study |
| Key Patients Feature: | patients with metastatic colorectal cancer refractory to standard chemotherapy |
| Biomarker: | Antipanitumumab antibodies |
| Biomark Analysis: | Antipanitumumab antibodies were detected in 3 (4.2%) of 71 patients with a postbaseline sample. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received panitumumab 6 mg/kg every 2 weeks. patients then were randomly assigned to the BSC arm of the phase 3 study received >/=1 panitumumab dose in this extension study. |
| Primary End Point: | safety; efficacy was also evaluated. |
| Secondary End Point: | NA |
| Patients Number: | 176 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | One (0.6%) patient had a complete response; 19 (11%) patients had a partial response; and 58 (33%) patients had stable disease. |
| Disease Control Rate: | 44% (n = 78). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median progression free survival time was 9.4 [95% confidence interval (CI): 8.013.4) weeks. |
| Median OS A vs. C: | Median overall survival time was 6.3 (95% CI: 5.16.8) months. |
| Adverse Event(agent arm): | Panitumumab was well tolerated. The most frequent treatmentrelated adverse events were skin toxic effects. Three (2%) patients had a grade 4 treatmentrelated adverse event. There were no infusion reactions. |
| Conclusions: | These findings are comparable to those from thephase 3 study and support panitumumab monotherapy for chemorefractory colorectal cancer. |