G14 - Intensity-modulated radiotherapy and cetuximab for frail patients with loco-regionally advanced head and neck cancer

Abstract

Background: The combination of radiotherapy (RT) and concomitant cetuximab demonstrated to be superior to RT alone in loco-regionally advanced squamous cell head and neck cancer (SCHNC). The benefit in terms of response rate, progressions-free survival (PFS) and overall survival (OS) has been obtained without increased toxicity. The objective of this study was to evaluate the clinical impact of such approach in frail patients. Methods: From january 2010 to december 2014 15 patients affected by stage III-IV SCHNC (oral cavity, oropharynx, and hypopharynx) not candidate to surgery or chemoradiation according to severe comorbidities or age (> 80 years) were treated with a combination of Intensity-Modulated RT (IMRT) and cetuximab with curative intent. Cetuximab was administered starting one week before IMRT at a loading dose of 400 mg/m2 i.v. followed by 250 mg/m2 i.v. weekly for a total of 8 infusions. Results: In this series the male/female ratio was 1.5 and the median age was 79 years. All patients but one completed IMRT along with 8 cycles of concomitant cetuximab whose median dose intensity was 95%. A complete response was achieved in 11 of 15 patients (73.3%). Three patients had residual nodal disease and underwent salvage neck dissection. Seven patients (46.7%) had loco-regional relapse and five of them developed distant metastases. With a median follow up of 58 months, the duration of locoregional control was 21 months (range, 1-59), median PFS was 16 months and median OS 34 months. Four patients (26.7%) were still alive at five years. Grade 3/4 adverse events occurred in 53.3% of cases, mostly oral mucositis and skin rash. With a careful pre-medication consisting of anti-histamine and steroidal drugs no infusional reactions were documented. One toxic death was registered in a 85-year old woman who died during IMRT as a consequence of severe sepsis. Conclusions: Cetuximab plus definitive IMRT is a feasible and effective treatment for loco-regionally advanced SCHNC. Even in frail patients it can provide good clinical outcomes along with an accettable toxicity profile. This combination allows a chance of cure for a subset of patients not suitable for chemotherapy or major surgery. The results in terms of PFS and OS are clearly inferior if compared to a standard patient population, nonetheless adding cetuximab to IMRT offer some chance of long survivorship to patients in poor clinical conditions, without dramatically altering their quality of life.