| General information |
| Database: | DB00283 |
| Objective: | They investigated the tolerability of cetuximab plus radiotherapy in Japanese patients with untreated locally advanced squamous cell carcinoma of the head and neck. |
| Authors: | Okano S, et al |
| Title: | Phase II study of cetuximab plus concomitant boost radiotherapy in Japanese patients with locally advanced squamous cell carcinoma of the head and neck. |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23479383 |
| 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: | 4 |
| Therapeutic Combination Content: | cetuximab+ concomitant boost radiotherapy |
| Study Type: | an openlabel, phase II study |
| Key Patients Feature: | Japanese patients with Stage III or IV (Union for International Cancer Control TNM classification) pathologically proven SCC of the oropharynx, hypopharynx or larynx confirmed by magnetic resonance imaging (MRI) and computed tomography (CT) and with tumor EGFR expression and an expected survival of at least 12 months |
| Biomarker: | epidermal growth factor receptorexpressing |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received cetuximab (400 mg/m(2) initial dose then 250 mg/m(2) weekly) for 7 weeks plus concomitant boost radiotherapy (weeks 27: once daily [1.8 Gy] for 3.6 weeks, then twice daily [1.8 Gy morning and 1.5 Gy afternoon] for 2.4 weeks). |
| Primary End Point: | tolerability, the main variable of which was treatment completion rate and the full dose of radiotherapy within 2 weeks over the planned schedule of less than and equal to 8 weeks. |
| Secondary End Point: | the best response 8 weeks after the completion of radiotherapy |
| Patients Number: | 22 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rate 8 weeks postradiotherapy was 82% (95% confidence interval 6095). |
| 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): | The most common grade 3/4 treatmentemergent adverse events were mucosal inflammation (73%); dermatitis (27%); and infection, radiation skin injury and stomatitis (23% each). |
| Conclusions: | Cetuximab plus concomitant boost radiotherapy can be safely administered to Japanese patients with locally advanced squamous cell carcinoma of the head and neck. Tolerability and efficacy they were in line with those reported in thephase III Bonner trial in a theystern population of patients with locally advanced squamous cell carcinoma of the head and neck. |