Entry Detail
General information | |
Database: | DB00034 |
Objective: | Panitumumab is a fully human antiepidermal growth factor receptor (EGFR) monoclonal antibody that improves progression free survival (PFS) in chemotherapyrefractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status. |
Authors: | Peeters M, et al |
Title: | Randomizedphase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as secondline treatment in patients with metastatic colorectal cancer. |
Journal: | J Clin Oncol |
Year: | 2010 |
PMID: | 20921462 |
Trial Design | |
Clinical Trial Id: | NCT00339183 |
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+fluorouracil, leucovorin, + irinotecan (FOLFIRI) |
Study Type: | a Randomizedphase III study |
Key Patients Feature: | Patients with mCRC, one prior chemotherapy regimen for mCRC, Eastern Cooperative Oncology Group performance status 0 to 2, and available tumor tissue for biomarker testing |
Biomarker: | KRAS status |
Biomark Analysis: | KRAS status was available for 91% of patients: 597 (55%) with wildtype (WT) KRAS tumors, and 486 (45%) with mutant (MT) KRAS tumors. |
Control Group Info: | FOLFIRI alone |
Treatment Info: | patients were randomly assigned 1:1 to panitumumab 6.0 mg/kg plus FOLFIRI versus FOLFIRI every 2 weeks. |
Primary End Point: | PFS and overall survival, prospectively analyzed by KRAS status |
Secondary End Point: | NA |
Patients Number: | 1186 |
Trial Results | |
DLT_MTD: | NA |
Objective Response Rate: | response rate was improved to 35% versus 10% with the addition of panitumumab. In patients with MT KRAS, there was no difference in efficacy. |
Disease Control Rate: | NA |
Median Time to Progression: | NA |
Median PFS A vs. C: | In the WT KRAS subpopulation, when panitumumab was added to chemotherapy, a significant improvement in PFS was observed (hazard ratio [HR] = 0.73; 95% CI, 0.59 to 0.90; P = .004); median PFS was 5.9 months for panitumumabFOLFIRI versus 3.9 months for FOLFIRI |
Median OS A vs. C: | A nonsignificant trend toward increased OS was observed; median OS was 14.5 months versus 12.5 months, respectively (HR = 0.85, 95% CI, 0.70 to 1.04; P = .12); |
Adverse Event(agent arm): | Adverse event rates were generally comparable across arms with the exception of known toxicities associated with antiEGFR therapy. |
Conclusions: | Panitumumab plus FOLFIRI significantly improved PFS and is welltolerated as secondline treatment in patients with WT KRAS mCRC. |