Head and neck cancer (HNC) requires a multidisciplinary management, especially in locally advanced stage disease. Treatment advances in surgery, radiation therapy (RT) and chemotherapy are partially responsible for improvement in survival. Therefore a superior number of survivors run into acute and long-term consequences of HNC treatment. Physiologic functions preservation becomes paramount. Platinum-based chemotherapy with concomitant RT is the principal non surgical treatment, mainly with the aim of avoiding surgical destructive results. Although approximately 25% of HNC patients are aged 70 years and over, in the the past decades elderly patients were particularly under-represented in the clinical trials, accounting fewer than 10% of participants. Elderly population is highly heterogeneous, due to age-based differences in coexisting comorbidities, global performance status and geriatric syndromes such as cognitive and functional disabilities. Often treatments with curative intent are not offered to elderly, for fear of major side effects , reduced quality of life and death.
We designed a pilot study exclusively for elderly patients. The purpose is to analyze the clinical outcomes and the treatment tolerance of moderate hypofractionated RT with a total dose of 60 Gy in 20 fractions, 5 daily fractions/week, plus concomitant cetuximab, monoclonal antibody against the epidermal growth factor receptor (EGFR), in elderly patients with locally advanced HNC. Cetuximab will be administered at an initial loading dose of 400 mg/m2 one week before RT, followed by weekly injections at 250 mg/m2 during RT. The aim is to achieve a good rate of tumor control without toxicity increase, also thanks to Intensity Modulation Radiotherapy (IMRT) and image-guided RT (IGRT). It is hoped that this study will be potentially useful as a reference in the future for a multi-center randomized controlled clinical trial evaluating the best treatment approach in this setting of patients.
