| General information |
| Database: | DB00328 |
| Objective: | The aim of this investigation was to evaluate elevated tumor EGFR gene copy number as a predictive biomarker in EXTREME study patients. |
| Authors: | Licitra L, et al |
| Title: | Evaluation of EGFR gene copy number as a predictive biomarker for the efficacy of cetuximab in combination with chemotherapy in the firstline treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck: EXTREME study. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 21048039 |
| 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 squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab + chemotherapy |
| Study Type: | phase III |
| Key Patients Feature: | nclusion criteria included age 18 years, untreated R/M SCCHN, ineligibility for local therapy, KarnofskyPerformance Score of 70% and adequate organ function. patients wereexcluded if they had received prior surgery or radiotherapy within 4 weeksof study entry or prior systemic chemotherapy (apart from for locallyadvanced disease). |
| Biomarker: | KRAS Mutation |
| Biomark Analysis: | KRAS mutation status was not significantly associated with any efficacy parameter |
| Control Group Info: | single arm |
| Treatment Info: | Dualcolor FISH was used to determine absolute and relative EGFR copy number. Models of differing stringencies were used to score and investigate whether increased copy number was predictive for the activity of cetuximab plus platinum/5FU. |
| Primary End Point: | overall survival. |
| Secondary End Point: | PFS, best overall response, disease control, timetotreatment failure, duration of response and safety. |
| Patients Number: | 312 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Considering each of the models tested, no association of EGFR copy number with overall survival, progression free survival or best overall response was found for patients treated with cetuximab plus platinum/5FU. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Cetuximab + chemotherapy : FISH+ vs. FISH 6.2 vs 5.7 months (95% CI: 0.58-1.27; P=0.46). Chemotherapy alone: FISH+ vs. FISH 3.1 vs 4.1 months (95% CI:0.71-1.54; P=0.81). |
| Median OS A vs. C: | Cetuximab + chemotherapy : FISH+ vs. FISH 10.5 vs 10.6 months (95% CI: 0.69-1.51; P=0.93). Chemotherapy alone: FISH+ vs. FISH 7.2 vs 7.8 months (95% CI:0.71-1.51; P=0.86). |
| Adverse Event(agent arm): | NA |
| Conclusions: | Tumor EGFR copy number is not a predictive biomarker for the efficacy of cetuximab plus platinum5FU as firstline therapy for patients with RM SCCHN. |