External Beam Radiation Therapy Is Associated With Increased Variability in Retinal Venous Oxygenation

Abstract

Purpose/Objective(s): The prognosis for squamous cell head and neck cancer after surgical treatment and adjuvant chemo radiation is unsatisfactory in cases of close resection margins <5 mm (CM) or extracapsular extent at the lymph nodes (ECE). Therefore, we conducted a multicenter Phase II study to investigate the toxicity and efficacy of adjuvant radiation therapy in combination with concurrent cisplatin, 5-fluorouracil (5-FU), and cetuximab followed by maintenance therapy with cetuximab for 6 months. Here, we present the preliminary results on feasibility and toxicity. Materials/Methods: Patients with squamous cell cancer of the head and neck after primary surgery were eligible for the study, if a CM or ECE was detected. Cisplatin (20 mg/m d1-5 and d29-33) and 5-FU as continuous infusion (600 mg/m d1-d5 + d29-33) were given concurrently to postoperative radiation therapy using an integrated boost IMRT-technique (1.8/ 2.0/2.2 Gy QD) to a total dose of 61.6 Gy. Cetuximab started 7 days prior chemoradiation therapy with a loading dose of 400 mg/m followed by weekly cetuximab (250 mg/m) during chemoradiation therapy. Maintenance cetuximab started after completion of chemoradiation therapy plus cetuximab with 500 mg/m every 2 weeks over a 6-month period. Results: Fifty-five of 80 planned pts (46 male, 9 female, mean age 55.6, range, 29-70 years) have finished chemoradiation therapy, 50 are evaluable for toxicity. Concurrent Chemoradiation therapy plus Cetuximab was associated with grade 3-4 (CTC 3.0) mucositis, radiation dermatitis, and skin reactions outside the radiation portals in 46%, 28%, and 14% of pts, respectively. One toxic death occurred (peritonitis at day 57). Cetuximab was terminated in 10% of all pts (allergic reactions) after the first application. In 22% of all pts Cetuximab was discontinued during the last 2 weeks or at the end of chemo radiation therapy. Of those pts embarking on maintenance therapy, 80% were still on Cetuximab after 3 and 63% after 5 months. 48% completed 6 months maintenance therapy. Conclusions: Adjuvant radio chemotherapy in combination with cetuximab followed by maintenance cetuximab is feasible with toxicity in the expected range. Compliance to maintenance cetuximab was satisfactory during the first 3-5 months. Author Disclosure: C. Matuschek: None. E. Boelke: None. C. Belka: None. U. Ganswindt: None. M. Henke: None. P. Stegmaier: None. M. Bamberg: None. S. Welz: None. J. Debus: None. W. Budach: None.