| General information |
| Database: | DB00031 |
| Objective: | Panitumumab is a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFR). They compared the activity of panitumumab plus best supportive care (BSC) to that of BSC alone in patients with metastatic colorectal cancer who had progressed after standard chemotherapy. |
| Authors: | Van Cutsem E, et al |
| Title: | Openlabelphase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapyrefractory metastatic colorectal cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17470858 |
| 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 openlabelphase III trial |
| Key Patients Feature: | metastatic colorectal cancer patients with 1% or more EGFR tumor cell membrane staining, measurable disease, and radiologic documentation of disease progression during or within 6 months of most recent chemotherapy |
| Biomarker: | 1% or more EGFR tumor cell membrane staining |
| Biomark Analysis: | NA |
| Control Group Info: | best supportive care alone |
| Treatment Info: | randomly assigned pts to panitumumab 6 mg/kg every 2 weeks plus BSC (n = 231) or BSC alone (n = 232). Tumor assessments by blinded central review were scheduled from week 8 until disease progression. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | objective response, overall survival (OS), and safety. BSC patients who progressed could receive panitumumab in a crossover study. |
| Patients Number: | 463 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rates also favored panitumumab over BSC; after a 12month minimum followup, response rates were 10% for panitumumab and 0% for BSC (P < .0001). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Panitumumab significantly prolonged PFS ([HR], 0.54; 95% CI, 0.44 to 0.66, [P < .0001]). Median PFS time was 8 weeks (95% CI, 7.9 to 8.4) for panitumumab and 7.3 weeks (95% CI, 7.1 to 7.7) for BSC. Mean (standard error) PFS time was 13.8 (0.8) weeks for panitumumab and 8.5 (0.5) weeks for BSC. |
| Median OS A vs. C: | No difference was observed in OS (HR, 1.00; 95% CI, 0.82 to 1.22), which was confounded by similar activity of panitumumab after 76% of BSC patients entered the crossover study. |
| Adverse Event(agent arm): | Panitumumab was well tolerated. Skin toxicities, hypomagnesaemia, and diarrhea were the most common toxicities observed. No patients had grade 3/4 infusion reactions. |
| Conclusions: | Panitumumab significantly improved PFS with manageable toxicity in patients with chemorefractory colorectal cancer. |