An open-label, single-arm phase II clinical study of induction chemotherapy and sequential Nimotuzumab combined with concurrent chemoradiotherapy in N3M0 stage nasopharyngeal carcinoma.

INTRODUCTION

The purpose of this study was to analyze the efficacy and safety of induction chemotherapy and sequential Nimotuzumab combined with concurrent chemoradiotherapy in N3M0 stage nasopharyngeal carcinoma (NPC).

METHODS

This study included 45 N3 stage NPC patients treated with induction chemotherapy, sequential Nimotuzumab plus concurrent chemoradiotherapy. The intensity modulated radiation therapy (IMRT) doses for planning target volume (PTV) were 70-72 Gy for gross disease in the nasopharynx, and 66-70 Gy for positive lymph nodes. The doses for high risk and low risk regions PTV were 60-62 Gy and 54-56 Gy in 31-33 fractions. Induction chemotherapy consisted of 3 cycles of docetaxel (75 mg/m2, day 1) plus lobaplatin (30 mg/m2, day 1). Concurrent with radiotherapy, patients received chemotherapy consisting of lobaplatin 50 mg/m2, day 1. Targeted drug therapy given on the first time of IMRT consisted of Nimotuzumab (200mg, iv weekly for 7 courses). Cycle repetition of chemotherapy was every 21 days.

RESULTS

The efficacy of 3 cycles of induction chemotherapy before the start of concurrent chemoradiotherapy was 100%, and the overall efficacy after the end of chemoradiotherapy was also 100%. Three-year overall survival (OS), distant metastasis-free survival (DMFS), locoregional control (LRC) and progression-free survival (PFS) rates were 85.6, 81.9, 97.8 and 79.5%, respectively. The main adverse reactions were hematologic toxicity, particularly neutropenia (100%), anemia (88.9%) and thrombocytopenia (68.9%). Patients developed a relatively low degree of mucositis and vasculitis. Chronic toxicity was mainly grade I-II radiation-induced xerostomia (18 cases). There were 11 cases of hearing loss and 4 cases of neck skin fibrosis. No cases of treatment-related death and radiation-induced cranial nerve damage or trismus were observed.

CONCLUSION

In N3 stage NPC, induction chemotherapy and sequential Nimotuzumab plus concurrent chemoradiotherapy yielded an excellent survival benefit, and the toxicities were tolerable. Distant metastasis was the main cause of treatment failure.