| General information |
| Database: | DB00255 |
| Objective: | Cetuximab is effective in platinumresistant recurrent or metastatic squamouscell carcinoma of the head and neck. They investigated the efficacy of cetuximab plus platinumbased chemotherapy as firstline treatment in patients with recurrent or metastatic squamouscell carcinoma of the head and neck. |
| Authors: | Vermorken JB, et al |
| Title: | Platinumbased chemotherapy plus cetuximab in head and neck cancer. |
| Journal: | N Engl J Med |
| Year: | 2008 |
| PMID: | 18784101 |
| Trial Design |
| Clinical Trial Id: | NCT00122460 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Platinumbased chemotherapy +cetuximab |
| Study Type: | a phase III, randomized trial |
| Key Patients Feature: | eligible patients with untreated recurrent or metastatic squamouscell carcinoma of the head and neck |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy alone |
| Treatment Info: | patients were assigned to receive cisplatin (at a dose of 100 mg per square meter of bodysurface area on day 1) or carboplatin (at an area under the curve of 5 mg per milliliter per minute, as a 1hour intravenous infusion on day 1) plus fluorouracil (at a dose of 1000 mg per square meter per day for 4 days) every 3 weeks for a maximum of 6 cycles and 222 patients to receive the same chemotherapy plus cetuximab (at a dose of 400 mg per square meter initially, as a 2hour intravenous infusion, then 250 mg per square meter, as a 1hour intravenous infusion per week) for a maximum of 6 cycles. |
| Primary End Point: | PFS, OS, toxicity |
| Secondary End Point: | NA |
| Patients Number: | 442 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | the addition of cetuximab increased the response rate from 20% to 36% (P<0.001). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The addition of cetuximab prolonged the median progression free survival time from 3.3 to 5.6 months (hazard ratio for progression, 0.54; P<0.001) |
| Median OS A vs. C: | Adding cetuximab to platinumbased chemotherapy with fluorouracil (platinumfluorouracil) significantly prolonged the median overall survival from 7.4 months in the chemotherapyalone group to 10.1 months in the group that received chemotherapy plus cetuximab (hazard ratio for death, 0.80; 95% confidence interval, 0.64 to 0.99; P=0.04). |
| Adverse Event(agent arm): | The most common grade 3 or 4 adverse events in the chemotherapyalone and cetuximab groups were anemia (19% and 13%, respectively), neutropenia (23% and 22%), and thrombocytopenia (11% in both groups). Sepsis occurred in 9 patients in the cetuximab group and in 1 patient in the chemotherapyalone group (P=0.02). Of 219 patients receiving cetuximab, 9% had grade 3 skin reactions and 3% had grade 3 or 4 infusionrelated reactions. There were no cetuximabrelated deaths. |
| Conclusions: | As compared with platinumbased chemotherapy plus fluorouracil alone, cetuximab plus platinumfluorouracil chemotherapy improved overall survival when given as firstline treatment in patients with recurrent or metastatic squamouscell carcinoma of the head and neck. |