OP0010 Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: Preliminary results of a phase 3 multicentre randomised controlled trial

Abstract

<h3>Background</h3> We aimed to assess the value of induction chemotherapy with cisplatin and fluorouracil plus docetaxel (TPF) plus concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC). <h3>Methods</h3> We did an open-label phase 3 multicentre randomised controlled trial at ten institutions in China. Patients with stage III–IVB (except T3–4N0, UICC/AJCC 7th edition) NPC were randomly assigned to receive induction chemotherapy plus CCRT (investigational group) or CCRT alone (control group). Patients in both groups received cisplatin 100mg/m² every 3weeks for three cycles, concurrently with intensity-modulated radiotherapy (IMRT). The investigational group received docetaxel (60mg/m² on day 1), cisplatin (60mg/m² on day 1), and fluorouracil (600mg/m² per day by continuous intravenous infusion on days 1–5) every 3weeks for three cycles before CCRT. Our primary endpoint was failure-free survival (FFS), and the sample size was 476 patients (238 per treatment group). This trial is registered with ClinicalTrials.gov, NCT01245959. <h3>Findings</h3> 241 patients were assigned to the investigational group and 239 to the control group. After a median follow-up of 18.6months (range 0.8–34months), the estimated 2-year FFS was 82.2% in the investigational group and 75.5% in the control group (hazard ratio [HR]=0.61, 95% confidence interval [CI] 0.39–0.97, <i>p</i>=0.04). The estimated 2-year distant failure-free survival (D-FFS) was 91.3% in the investigational group and 81.7% in the control group (HR =0.51, 95% CI 0.28–0.91, <i>p</i>=0.02). No significant differences in overall survival and locoregional failure-free survival were observed between the two arms. The rates of grade 3–4 neutropenia, diarrhoea, and stomatitis during induction chemotherapy were 35.1%, 7.1%, and 6.3%, respectively. <h3>Interpretation</h3> The preliminary results suggested that compared with CCRT alone, induction chemotherapy with TPF could significantly improve FFS and D-FFS in locoregionally advanced NPC. Long-term follow-up is needed to establish an eventual efficacy of TPF induction chemotherapy.