| General information |
| Database: | DB00036 |
| Objective: | To evaluate panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated wildtype (WT) KRAS exon 2 (codons 12 and 13) metastatic colorectal cancer (mCRC). A prespecified secondary objective was to assess treatment effects in an extended RAS analysis that included exons 2, 3, and 4 of KRAS and NRAS. |
| Authors: | Schwartzberg LS, et al |
| Title: | PEAK: a randomized, multicenterphase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wildtype KRAS exon 2 metastatic colorectal cancer. |
| Journal: | J Clin Oncol |
| Year: | 2014 |
| PMID: | 24687833 |
| Trial Design |
| Clinical Trial Id: | NCT00819780 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced/unresectable or metastatic BRAF V600 or NRASmutant melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | panitumumab+ modified fluorouracil, leucovorin, + oxaliplatin (mFOLFOX6) vs. bevacizumab+ mFOLFOX6 |
| Study Type: | PEAK: a randomized, multicenterphase II study |
| Key Patients Feature: | patients with previously untreated, unresectable, wildtype KRAS exon 2 metastatic colorectal cancer. |
| Biomarker: | wildtype KRAS exon 2 |
| Biomark Analysis: | as in the conclusion |
| Control Group Info: | bevacizumab+mFOLFOX6 |
| Treatment Info: | Patients with WT KRAS exon 2 tumors were randomly assigned at a onetoone ratio to panitumumab plus mFOLFOX6 or bevacizumab plus mFOLFOX6. |
| Primary End Point: | progression free survival (PFS); |
| Secondary End Point: | overall survival (OS) and safety. |
| Patients Number: | 278 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | In the WT KRAS exon 2 intenttotreat group, PFS was similar between arms (hazard ratio [HR], 0.87; 95% CI, 0.65 to 1.17; P = .353). In the WT RAS subgroup (WT exons 2, 3, and 4 of KRAS and NRAS), PFS favored the panitumumab arm (HR, 0.65; 95% CI, 0.44 to 0.96; P = .029). |
| Median OS A vs. C: | Median OS was 34.2 and 24.3 months in the panitumumab and bevacizumab arms, respectively (HR, 0.62; 95% CI, 0.44 to 0.89; P = .009). Median OS was 41.3 and 28.9 months (HR, 0.63; 95% CI, 0.39 to 1.02; P = .058) in the panitumumab and bevacizumab arms, respectively. |
| Adverse Event(agent arm): | Treatment discontinuation rates because of adverse events were similar between arms. |
| Conclusions: | PFS was similar and OS was improved with panitumumab relative to bevacizumab when combined with mFOLFOX6 in patients with WT KRAS exon 2 tumors. Patients with WT RAS tumors seemed to experience more clinical benefit with antiepidermal growth factor receptor therapy. |