An open, multicenter clinical study on cetuximab combined with intensity modulated radiotherapy (IMRT) plus concurrent chemotherapy in nasopharyngeal carcinoma (NPC): Preliminary report.

Abstract

5577 Background: To evaluate the safety and efficacy of cetuximab combined with IMRT + concurrent cisplatin chemotherapy in patients with loco-regionally advanced NPC in a Chinese multicenter clinical study. Methods: Patients with primary stage III – IVb non- keratinizing NPC were enrolled. The planned dose of IMRT to gross tumor volume (GTV) was 66 - 75.9 Gy in 30-33 fractions. Cisplatin (80mg/m2,q3week [w]) and cetuximab (400mg/m2 one w before radiation, and then 250mg/m2/w) were given concurrently for 6 - 7 weeks. The response rate was evaluated according to RECIST, and adverse events (AEs) were graded according to CTCAE v3.0. Results: From July 2008 to April 2009, 100 patients were enrolled with 74 male and 26 female. Median age was 43 years old. The proportion of patients with stage III, IVa and IVb disease was 71%, 22% and 7%, respectively. Actual median dose to GTV was 69.96 Gy. Median dose of cisplatin was 133.17 mg, median first-dose of cetuximab was 690 mg, and median weekly dose was 410 mg. 99% of all included patients finished the planned treatment. AEs were well tolerated and manageable, mainly consisting of acneiform skin eruptions, dermatitis, mucositis, xerostomia and slight ALT elevations (grade 1 - 2). Only one patient had a mild allergic reaction, happening in the first w of cetuximab therapy. 64% of patients had ≥ grade 2 acneiform eruptions, mainly starting at the third week of cetuximab treatment. From the third week of radiotherapy, 58% and 90% of the patients began to suffer from grade 1 dermatitis and ≥ grade 2 mucositis, respectively, while grade 4 mucositis (spontaneous bleeding) was observed in 2% of the patients. 40% of patients experienced ≥ grade 2 xerostomia. Besides mucositis, no other grade 4 AEs were observed. Bone marrow suppression was mild, and only 8%, 4% and 5% patients had ≥ grade 2 decreased ANC, Plt and Hb, respectively. At the third month after treatment, 1 patient died of dysphagia. Clinical remission rate (CR + PR) was 100%. Conclusions: The combined treatment modality of IMRT + concurrent chemotherapy + cetuximab in loco- regionally advanced NPC was well tolerated, with a very encouraging clinical response rate. No significant financial relationships to disclose.