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

Background 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). Methods 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 100 mg/m 2 every 3 weeks for three cycles, concurrently with intensity-modulated radiotherapy (IMRT). The investigational group received docetaxel (60 mg/m 2 on day 1), cisplatin (60 mg/m 2 on day 1), and fluorouracil (600 mg/m 2 per day by continuous intravenous infusion on days 1–5) every 3 weeks 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. Findings 241 patients were assigned to the investigational group and 239 to the control group. After a median follow-up of 18.6 months (range 0.8–34 months), 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, p  = 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, p  = 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. Interpretation 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.