| General information |
| Database: | DB00279 |
| Objective: | Close resection margins < 5 mm (CM) or extra capsular extent at the lymph nodes (ECE) impair the prognosis of patients with squamous cell cancer of the head and neck (SCCHN) scheduled for adjuvant radiochemotherapy. They conducted a multicenterphase II study to investigate toxicity and efficacy of additional cetuximab administered concomitantly and as maintenance for the duration of 6 months following adjuvant radiochemotherapy., Ppreliminary results on feasibility and acute toxicity on skin and mucosa are presented in this article. |
| Authors: | Matuschek C, et al |
| Title: | Feasibility of 6month maintenance cetuximab after adjuvant concurrent chemoradiation plus cetuximab in squamous cell carcinoma of the head and neck. |
| Journal: | Strahlenther Onkol. |
| Year: | 2013 |
| PMID: | 23824104 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | squamous cell carcinoma of the oropharnyx, larynx, or oral cavity |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | postoperative radiochemotherapy (RCT)+cetuximab |
| Study Type: | A multicenter, uncontrolled openlabelphase II trial |
| Key Patients Feature: | Eligible patients had a diagnosis of histologically confirmed, surgically resected squamous cell carcinoma (SCC) of the oropharnyx, larynx, or oral cavity with high risk of locoregional recurrence, receiving cetuximab in combination with cisplatin and 5FU |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | 61.6 Gy (1.8/2.0/2.2 Gy, days 136) were administered using an integrated boost intensitymodulated radiotherapy (IMRT) technique. Cisplatin (20 mg/m(2), days 15 and days 2933) and 5fluorouracil (5FU) as continuous infusion (600 mg/m(2), days 15 + days 2933) were given concurrently. Cetuximab was started 7 days prior to radiochemotherapy at 400 mg/m(2) followed by weekly doses of 250 mg/m(2). Maintenance cetuximab began after radiochemotherapy at 500 mg/m(2) every 2 weeks for 6 months. |
| Primary End Point: | the rate of patients experiencing grade 3 or 4 acute toxicities on skin and mucosa. |
| Secondary End Point: | the 2year diseasefree survival rate, the incidence of locoregional relapses, progression free survival, overall survival, the rate of patients with secondary primary neoplasm, and the incidence of late toxicity. |
| Patients Number: | 55 |
| Trial Results |
| DLT_MTD: | One toxic death occurred (peritonitis at day 57). Cetuximab was terminated in 5 patients due to allergic reactions after the first application. In addition, 22 % of patients discontinued cetuximab within the last 2 weeks or at the end of radiochemotherapy. Of patients embarking on maintenance treatment, 80 % were still on cetuximab at 3 months and 63 % at 5 months. Concurrent and maintenance treatment with cetuximab could be administered as scheduled in 48 % of patients. |
| Objective Response Rate: | NA |
| 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): | Grade 34 (CTC 3.0) mucositis, radiation dermatitis, and skin reactions outside the radiation portals were documented for 46, 28, and 14 % of patients, respectively. |
| Conclusions: | Adjuvant radiochemotherapy with concomitant and maintenance cetuximab is feasible and acute toxicities are within the expected range. Compliance within the first 35 months is moderate. |