| General information |
| Database: | DB00263 |
| Objective: | For stage II and III head and neck squamous cell carcinoma (HNSCC) treated with radiotherapy alone, locoregional recurrence is the main cause of treatment failure. Strategies to improve locoregional control should not be at the expense of increased late normal tissue toxicity. They investigated doseintensified hypofractionated intensitymodulated radiotherapy (IMRT) with synchronous cetuximab. |
| Authors: | Thomson DJ, et al |
| Title: | Dose intensified hypofractionated intensitymodulated radiotherapy with synchronous cetuximab for intermediate stage head and neck squamous cell carcinoma. |
| Journal: | Acta Oncol. |
| Year: | 2015 |
| PMID: | 25279959 |
| Trial Design |
| Clinical Trial Id: | EudraCT number: 200700074136 |
| 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: | Dose intensified hypofractionated intensitymodulated radiotherapy with synchronous cetuximab |
| Study Type: | a phase I/II trial |
| Key Patients Feature: | patients with UICC stage III or high risk stage II (T2-3N0, T1-3N1) oropharyngeal, laryngeal (stage II glottic laryngeal excluded) or hypopharyngeal squamous cell carcinoma. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Pts received three dose level simultaneous integrated boost IMRT, 62.5 Gy in 25 daily fractions to planning target volume one over five weeks with synchronous cetuximab. |
| Primary End Point: | acute toxicity. |
| Secondary End Point: | late toxicity and quality of life; locoregional control, causespecific and overall survival. |
| Patients Number: | 27 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | there were five (18.5%) locoregional recurrences and the overall causespecific survival was 79% (95% CI 5392). |
| Adverse Event(agent arm): | Grade 3 acute toxicities included: pain (81%), oral mucositis (78%) and dysphagia (41%). There were few grade 3 physicianrecorded late toxicities, including: pain (11%), problems with teeth (8%) and weight loss (4%). At 12 months, only one (4%) patient required a feeding tube, inserted prior to treatment due to dysphagia. The maximal/peak rates of patientreported late toxicities included: severe pain (11%), any dry mouth (89%) and swallowing dysfunction that required a soft/liquid diet (23%). |
| Conclusions: | This regimen is safe with acceptable acute toxicity, low rates of late toxicity and impact on quality of life at 12 months following treatment. Further evaluation is recommended. |