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

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.