| General information |
| Database: | DB00710 |
| Objective: | Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor. Results from the primary analysis of a phase 3, randomized, controlled study showed a statistically significant improvement in progression free survival for patients receiving panitumumab; however, overall survival was confounded by best supportive care (BSC) patients that crossed over to panitumumab therapy after disease progression. |
| Authors: | PoulinCostello M, et al |
| Title: | An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer. |
| Journal: | Target Oncol. |
| Year: | 2013 |
| PMID: | 23625191 |
| Trial Design |
| Clinical Trial Id: | NCT00113763 |
| 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, multicenter, phase III trial |
| Key Patients Feature: | eligible patients had documenteddisease progression after failure of fluoropyrimidines, prespecified exposure to oxaliplatin and irinotecan, Eastern Cooperative Oncology Group (ECOG) performance status02, no brain metastases, no systemic chemotherapy, orradiotherapy within 30 days before randomization, and noprior antiEGFR therapy. |
| Biomarker: | KRAS evaluable patients (both WT and MT) |
| Biomark Analysis: | The primary post hoc analysis showed a median overall survival of 6.4 months for all KRASevaluable patients randomized to panitumumab versus 4.4 months for patients with MT KRAS tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.5980.977). Similar results were observed for the two secondary post hoc analyses. |
| Control Group Info: | 463 patients were enrolled and randomized, 231 to panitumumab plus BSC versus 232 to BSCalone. |
| Treatment Info: | Patients were randomized 1:1 to receive panitumumab plus BSC or BSC alone, and randomization was stratified by geographicregion. Panitumumab was administered intravenously over 1 h at 6.0 mg/kg every 2 weeks (Q2W). Treatment was administered until disease progression or unacceptabletoxicity |
| Primary End Point: | the OS treatment effect in both the ITT and WT KRAS populations after discounting the effect of crossover from the BSC group to panitumumab after disease progression. |
| Secondary End Point: | NA |
| Patients Number: | 463 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 6.4 months for all KRASevaluable patients randomized to panitumumab versus 4.4 months for patients with MT KRAS tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.5980.977). |
| Adverse Event(agent arm): | NA |
| Conclusions: | These analyses suggest a positive treatment effect of panitumumab in both the overall and WT KRAS patient populations consistent with an improvement in overall survival relative to BSC. |