Randomized trial of induction paclitaxel-cisplatin-capecitabine versus cisplatin-fluorouracil for nasopharyngeal carcinoma

A multicenter randomized trial in China compared induction paclitaxel, cisplatin, and capecitabine (TPC) versus cisplatin and fluorouracil (PF) among patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LA-NPC; T4N0-2M0 or T any N3M0). Patients received two 21-day cycles of induction with TPC or PF, followed by concurrent chemoradiotherapy. Primary analysis of the trial found longer failure-free survival (FFS) in the TPC group compared with the PF group. Long-term follow-up of the trial has now been published. Among 238 patients (118 TPC; 120 PF), with a median follow-up of 89.1 months, the 5-year FFS rate was 77.6% in the TPC group and 62.9% in the PF group (HR 0.52; 95% CI 0.34-0.82). At 5 years, the distant metastasis-free survival rate was 87.8% in the TPC group and 78.8% in the PF group (HR 0.51; 95% CI 0.28-0.95), locoregional relapse-free survival rate was 92.0% and 82.1, respectively (0.43; 0.21-0.88), and overall survival rate was 89.6% and 82.2%, respectively (0.51; 0.25-0.95). Among patients with pretreatment Epstein-Barr virus DNA < 300 copies/ml, 5-year overall survival rate was 92.3% in the TPC group and 84.4% in the PF group; among those with higher EBV DNA levels, rates were 84.2% and 81.1%, respectively. Grade 3 or 4 adverse events occurred in 57.6% of patients receiving TPC and 65.8% of patients receiving PF. Treatment adherence was similar in the two groups. The authors conclude that among patients with high-risk LA-NPC, TPC induction chemotherapy was associated with higher 5-year progression-free survival rate than PF induction chemotherapy.