| General information |
| Database: | DB00029 |
| Objective: | Panitumumab improves progression free survival (PFS), is approved as monotherapy for patients with chemotherapyrefractory metastatic colorectal cancer (mCRC). The Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) was designed to evaluate the efficacy and safety of panitumumab plus infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as initial treatment for mCRC. |
| Authors: | Douillard JY, et al |
| Title: | Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as firstline treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 20921465 |
| Trial Design |
| Clinical Trial Id: | NCT00364013 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | panitumumab + infusional fluorouracil, leucovorin, + oxaliplatin (FOLFOX4) |
| Study Type: | a Randomized, phase III trial |
| Key Patients Feature: | patients with no prior chemotherapy for mCRC, Eastern Cooperative Oncology Group performance status of 0 to 2, and available tissue for biomarker testing |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | FOLFOX4 alone |
| Treatment Info: | patients were randomly assigned 1:1 to receive panitumumabFOLFOX4 versus FOLFOX4. |
| Primary End Point: | PFS; |
| Secondary End Point: | overall survival (OS) was a secondary end point. Results were prospectively analyzed on an intenttotreat basis by tumor KRAS status. |
| Patients Number: | 1183 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | In the WT KRAS stratum, the RR was 55% for panitumumabFOLFOX4 and 48% for FOLFOX4 (stratified odds ratio, 1.35; P = .068). In the MT KRAS stratum, the RR was 40% in each arm. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | In the wildtype (WT) KRAS stratum, panitumumabFOLFOX4 significantly improved PFS compared with FOLFOX4 (median PFS, 9.6 v 8.0 months, respectively; hazard ratio [HR], 0.80; 95% CI, 0.66 to 0.97; P = .02).In the mutant KRAS stratum, PFS was significantly reduced in the panitumumabFOLFOX4 arm versus the FOLFOX4 arm (HR, 1.29; 95% CI, 1.04 to 1.62; P = .02) |
| Median OS A vs. C: | A nonsignificant increase in OS was also observed for panitumumabFOLFOX4 versus FOLFOX4 (median OS, 23.9 v 19.7 months, respectively; HR, 0.83; 95% CI, 0.67 to 1.02; P = .072).In the mutant KRAS stratum, median OS was 15.5 months versus 19.3 months, respectively (HR, 1.24; 95% CI, 0.98 to 1.57; P = .068). |
| Adverse Event(agent arm): | Adverse event rates were generally comparable across arms with the exception of toxicities known to be associated with antiEGFR therapy. |
| Conclusions: | This study demonstrated that panitumumabFOLFOX4 was well tolerated and significantly improved PFS in patients with WT KRAS tumors and underscores the importance of KRAS testing for patients with mCRC. |