| General information |
| Database: | DB00288 |
| Objective: | To assess the effect on progression free and overall survival from the addition of cetuximab to paclitaxelbased chemoradiation for patients with squamous cell head and neck cancer from Brown University Oncology Group studies. |
| Authors: | Birnbaum A, et al |
| Title: | Cetuximab, paclitaxel, carboplatin, and radiation for head and neck cancer: a survival analysis of a Brown University Oncology Groupphase II study. |
| Journal: | Am J Clin Oncol. |
| Year: | 2014 |
| PMID: | 23275269 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | Cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell cancer of the head and neck without distant organ metastases |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Cetuximab, paclitaxel, carboplatin, + radiation |
| Study Type: | a phase II study |
| Key Patients Feature: | patients with stage III or IV squamous cell head and neck cancer with no previous chemotherapy or radiation therapy. Patients with distant metastases to the noncervical lymph nodes or other organs were ineligible. patients were required to be 18 years or older and have a Karnofsky performance status >=70. |
| Biomarker: | Expression of the epidermal growth factor receptor (EGFR) |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received 4 weeks of induction cetuximab(400 mg/m2 for week 1, then 250 mg/m2/wk for 3 wk) followed by weekly cetuximab, paclitaxel, carboplatin, and concurrent radiation. Recurrence and survival data were compared with previous Brown University studies utilizing the same paclitaxelbased chemoradiation with and without induction chemotherapy. |
| Primary End Point: | PFS, OS, safety |
| Secondary End Point: | NA |
| Patients Number: | 37 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The progression free survival at 3 years for all 37 patients initiating chemoradiation was 54% |
| Median OS A vs. C: | The overall survival at 3 years for all 37 patients initiating chemoradiation was 57% |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of cetuximab to paclitaxel, carboplatin, and radiation achieves overall survival that is virtually identical to prior Brown University Oncology Group studies of paclitaxelbased chemoradiation without cetuximab. Improvements in locoregional control are needed despite the use of 3 agents to enhance the effects of radiation. |