| General information |
| Database: | DB00327 |
| Objective: | To explore the response and toxicity of advanced nonmetastatic squamous cell carcinomas of upper aerodigestive tract (SCCUADT) to a combination of cetuximab concomitant with gemcitabine and radiotherapy. |
| Authors: | Granados Garc¨ªa M, et al |
| Title: | Cetuximab concomitant with gemcitabine and radiotherapy in advanced squamous cell carcinomas of upper aerodigestive tract: a pilot study. |
| Journal: | Clin Transl Oncol. |
| Year: | 2011 |
| PMID: | 21324799 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | advanced squamous cell carcinomas of upper aerodigestive tract |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Cetuximab concomitant with gemcitabine and radiotherapy |
| Study Type: | a pilot study |
| Key Patients Feature: | pts with advanced squamous cell carcinomas of upper aerodigestive tract |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients with concomitant treatment of cetuximab (400 mg/m(2) as uploading dose, then 250 mg/m(2), IV) concomitant with gemcitabine (50 mg/m(2)) weekly for seven courses, and radiotherapy in classical fractionation until completion of 70 Gy. |
| Primary End Point: | complete response (CR) to treatment and toxicity. |
| Secondary End Point: | NA |
| Patients Number: | 20 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | CR was 82.4%, overall response was 100%. Neck disease reached CR in 61.5% and partial in 38.5% of patients. The main toxicities were nausea, lymphopenia, neutropenia and mucositis. Grade 3 and 4 side effects were presented in 70.6% of patients, but mucositis, and lymphopenia without clinical repercussions, occurred in 88.2% of patients. Gastrostomy was required in 11.8% of patients to maintain nutrition. Radioepithelitis developed in 76.5%, but only three of these (23.1%) were grade III. Median overall survival was 53 months (range 655 months) and median progression free survival has not yet been reached at the time of evaluation. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Although toxicity is important, this approach has interesting activity and deserves further investigation. |