Multicenter phase 3 trial of induction TPF followed by CCRT versus CCRT and adjuvant PF in locally advanced nasopharyngeal carcinoma

A multicenter phase 3 trial in China compared induction with docetaxel, cisplatin, and fluoroacil (TPF) combined with concurrent chemoradiotherapy (CCRT) (IC group) versus CCRT and sequential PF adjuvant chemotherapy (AC group) among patients with locally advanced nasopharyngeal carcinoma (LA-NPC). The primary outcome was progression-free survival (PFS). The trial enrolled 266 patients with median follow-up duration of 39 months (range 3-66). The 3-year PFS rate was similar between the two groups: 79.0% in the IC group and 74.5% in the AC group (HR 0.83; p=0.454). In the subgroup of patients with baseline positive plasma EBV DNA status, 3-year PFS rates were 89.3% in the IC group versus 71.9% in the AC group (p=0.034). The IC group experienced higher incidence rates of grade 3-4 leukopenia, neutropenia, and diarrhea (all p<0.05), while the AC group experienced higher incidence of nausea/vomiting, swallowing problems, and dry mouth during radiotherapy. The authors conclude that among all LA-NPC patients, induction TPF followed by CCRT did not improve PFS compared with CCRT and adjuvant PF and did increase hematological toxicity, but reduced incidence rates of nausea/vomiting, swallowing problems and dry mouth.