| General information |
| Database: | DB00993 |
| Objective: | The FOLFOXIRI regimen developed by the Gruppo Oncologico Nord Ovest (GONO) demonstrated higher activity and efficacy compared with FOLFIRI in metastatic colorectal cancer (mCRC). Panitumumab is effective in some patients with KRAS codon 1213 wildtype mCRC. KRAS codon 61, HRAS, NRAS, and BRAF V600E mutations might predict resistance to antiepidermal growth factor receptor antibodies. |
| Authors: | Fornaro L, et al |
| Title: | FOLFOXIRI in combination with panitumumab as firstline treatment in quadruple wildtype (KRAS, NRAS, HRAS, BRAF) metastatic colorectal cancer patients: a phase II trial by the Gruppo Oncologico Nord Ovest (GONO). |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23666916 |
| Trial Design |
| Clinical Trial Id: | NCT01358812 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | quadruple wildtype (KRAS, NRAS, HRAS, BRAF) advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | FOLFOXIRI + panitumumab |
| Study Type: | a phase II trial by the Gruppo Oncologico Nord Ovest (GONO) |
| Key Patients Feature: | wildtype KRAS, HRAS, NRAS (codon 121361), and BRAF unresectable mCRC patients |
| Biomarker: | quadruple wildtype (KRAS, NRAS, HRAS, BRAF) |
| Biomark Analysis: | Activity and secondary resectability of metastases among RasBRAF wildtype patients are promising |
| Control Group Info: | single arm |
| Treatment Info: | the combination of panitumumab (6 mg/kg on day 1) with a slightly modified GONOFOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, and folinate 200 mg/m2 on day 1, followed by fluorouracil 3000 mg/m2 as a 48h continuous infusion starting on day 1) repeated every 2 weeks as firstline treatment |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 87 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 89% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.3 months (95% CI 9.712.9 months). |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | After amendment, most common grade 3-4 adverse events reported during induction treatment were neutropenia (48%; febrile neutropenia: 5%), diarrhoea (35%), asthenia (27%), stomatitis (14%), and skin toxic effect (14%). One treatmentrelated death was registered. |
| Conclusions: | Adding panitumumab to FOLFOXIRI is feasible decreasing the dose of fluorouracil and irinotecan to reduce the risk of diarrhoea. Activity and secondary resectability of metastases among RasBRAF wildtype patients are promising. |