Final Results of a Multi-institutional Phase II Trial of Re-Irradiation with Concurrent Weekly Cisplatin and Cetuximab for Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

Abstract

Background

The optimal regimen of chemotherapy and re-irradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multi-center Phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC.

Methods and Materials

Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS≥70 were eligible for this trial. Cetuximab 400mg/m² was delivered as a loading dose in Week 1 followed by weekly cetuximab 250mg/m² and cisplatin 30mg/m² concurrent with 6 weeks of IMRT to a dose of 60-66 Gy in 30 daily fractions. Patients who previously received both concurrent cetuximab and cisplatin with radiation or who received radiotherapy less than 6 months prior were ineligible.

Results

From 2009 to 2013, 48 patients enrolled on this trial. 2 did not receive any protocol treatment. Of the remaining 46 patients, 34 were male and 12 female, with a median age of 62 years (range 36-85). Treatment was feasible and only 1 patient did not complete the treatment course. Common Grade 3 or higher acute toxicities were lymphopenia (46%), pain (22%), dysphagia (13%), radiation dermatitis (13%), mucositis (11%) and anorexia (11%). There were no Grade 5 acute toxicities. Eight Grade 3 late toxicities were observed, 4 of which were swallowing-related. With a median follow-up of 1.38 years, the 1-year overall survival (OS) was 60.4% and 1-year recurrence-free survival was 34.1%. On univariate analysis, OS was significantly improved with young age (p=0.01). OS was not associated with radiation dose, surgery prior to re-XRT or interval from prior XRT.

Conclusions

Concurrent cisplatin and cetuximab with re-XRT is feasible and offers good treatment outcomes for patients with high-risk features. Younger patients had significantly improved OS.

ClinicalTrials.Gov Identifier

NCT00833261