| General information |
| Database: | DB00254 |
| Objective: | Therapy of recurrent/metastatic squamous cell carcinoma of the head and neck results in median progression free survival (PFS) of 2 months. These cancers are rich in epidermal growth factor receptor (EGFR). They wished to determine whether the addition of cetuximab, which inhibits activation of EGFR, would improve PFS. |
| Authors: | Burtness B, et al |
| Title: | Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. |
| Journal: | J Clin Oncol. |
| Year: | 2005 |
| PMID: | 16314626 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cisplatin+cetuximab |
| Study Type: | a randomized, multiinstitutional, phase III, placebocontrolled trial |
| Key Patients Feature: | Patients with recurrent/metastatic squamous cell carcinoma of the head and neck |
| Biomarker: | EGFR |
| Biomark Analysis: | Enhancement of response was greater for patients with EGFR staining present in less than 80% of cells. |
| Control Group Info: | cisplatin plus placebo |
| Treatment Info: | patients were randomly assigned to receive cisplatin every 4 weeks, with weekly cetuximab (arm A) or placebo (arm B). Tumor tissue was assayed for EGFR expression by immunohistochemistry. |
| Primary End Point: | PFS. |
| Secondary End Point: | response rate, toxicity, overall survival, and correlation of EGFR with clinical end points. |
| Patients Number: | 117 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rate was 26% [corrected] for arm A and 10% [corrected] for arm B (P = .03). Enhancement of response was greater for patients with EGFR staining present in less than 80% of cells |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.2 months versus 2.7 months. HR 0.78 (95% CI, 0.54 to 1.12). |
| Median OS A vs. C: | 9.2 months versus 8.0 months (P =0.21). The hazard ratio for survival by skin toxicity in cetuximabtreated patients was 0.42 (95% CI, 0.21 to 0.86). |
| Adverse Event(agent arm): | skin toxicity |
| Conclusions: | Addition of cetuximab to cisplatin significantly improves response rate. There was a survival advantage for the development of rash. progression free and overall survival they were not significantly improved by the addition of cetuximab in this study. |