Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study.

Summary Background To evaluate the clinical efficacies and toxicities of induction chemotherapy followed by concomitant cisplatin-chemoradiotherapy (CRT) or cetuximab-radiotherapy (ERT) in locally advanced nasopharyngeal carcinoma (NPC). Methods Previously untreated patients with stage III–IVb NPC were eligible. They were randomized to CRT arm: intensity modulated radiation therapy (IMRT) with weekly cisplatin (30 mg/m 2 /w) or ERT arm: IMRT with weekly cetuximab (loading dose of 400 mg/m 2 followed by weekly doses of 250 mg/m 2 ). Two cycles of induction chemotherapy (docetaxel 75 mg/m 2 d1 and cisplatin 80 mg/m 2 d1) were administered to both arms. Endpoints were survivals, toxicities and quality of life (QoL). Results Because of the unexpectedly high rates of grade 3/4 mucositis observed in the ERT arm, the study was closed ahead of schedule. A total of 44 patients (23 in CRT arm and 21 in ERT arm) were enrolled. All patients completed the scheduled induction chemotherapy and radical radiotherapy. The results showed better compliance ( P < 0.001) with more oral mucositis, acneiform rash and dysphagia ( P < 0.05) of cetuximab. The 3-year disease-free survival (DFS) were achieved as 78.3% and 85.7% ( P = 0.547) in CRT and ERT arm, respectively. In the analysis of QoL, the addition of cetuximab to radiotherapy temporarily increased the adverse symptoms but did not result in long-term dysfunction. Conclusions ERT was not more efficacious than CRT but was more likely to cause acute adverse events in LA NPC. The recommended treatment modality was still concurrent cisplatin-IMRT. The combination of TP induction chemotherapy and concurrent cetuximab-radiotherapy should only be used in selected patients. [ABSTRACT FROM AUTHOR]