| General information |
| Database: | DB00026 |
| Objective: | The NORDICVII multicenterphase III trial investigated the efficacy of cetuximab when added to bolus fluorouracil/folinic acid and oxaliplatin (Nordic FLOX), administered continuously or intermittently, in previously untreated metastatic colorectal cancer (mCRC). The influence of KRAS mutation status on treatment outcome was also investigated. |
| Authors: | Tveit KM, et al |
| Title: | Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in firstline treatment of metastatic colorectal cancer: the NORDICVII study. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22473155 |
| Trial Design |
| Clinical Trial Id: | NCT00145314 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab+bolus fluorouracil/folinic acid + oxaliplatin (Nordic FLOX) |
| Study Type: | The NORDICVII multicenterphase III trial |
| Key Patients Feature: | Patients eligible for inclusion were 18 to 75 years of age and had previously untreated advanced/metastatic adenocarcinoma of the colon or rectum, at least one measurable lesion according to RECIST criteria |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | 3 arms: Nordic FLOX (arm A), cetuximab and FLOX (arm B), or cetuximab combined with intermittent FLOX (arm C) |
| Treatment Info: | patients were randomly assigned to receive either standard Nordic FLOX (arm A), cetuximab and FLOX (arm B), or cetuximab combined with intermittent FLOX (arm C). |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | Overall survival (OS), response rate, R0 resection rate, and safety |
| Patients Number: | 566 |
| 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 ITT population, median PFS was 7.9, 8.3, and 7.3 months for the three arms, respectively (not significantly different). In patients with KRAS mutations, no significant difference was detected, although a trend toward improved PFS was observed in arm B. |
| Median OS A vs. C: | OS was almost identical for the three groups (20.4, 19.7, 20.3 months, respectively), and confirmed response rates were 41%, 49%, and 47%, respectively. In patients with KRAS wildtype tumors, cetuximab did not provide any additional benefit compared with FLOX alone. |
| Adverse Event(agent arm): | The regimens were well tolerated. |
| Conclusions: | Cetuximab did not add significant benefit to the Nordic FLOX regimen in firstline treatment of mCRC. |