Multicenter phase 3 trial of induction chemotherapy followed by radiotherapy versus chemoradiotherapy for nasopharyngeal carcinoma

Induction chemotherapy (CT) followed by concurrent chemoradiotherapy (CCRT) is recommended for locoregionally advanced nasopharyngeal carcinoma (LRA NPC) but is associated with high rates of acute toxic effects and low compliance. A phase 3 trial at five centers in China evaluated de-escalation of this therapy. LRA NPC patients were randomized to induction CT followed by radiotherapy alone (IC-RT group) versus induction CT followed by CCRT (IC-CCRT group). The noninferiority margin for three-year progression-free survival rate was established at 10%. The 3-year PFS rate was 76.2% with IC-RT versus 76.8% with IC-CCRT (p=0.01 for noninferiority). Incidence of grade 3 to 4 short-term toxic effects was lower in the IC-RT group compared with the IC-CRT group. No differences were observed for late toxic effects. The authors conclude that the results of this trial suggest that after induction CT for LRA NPC, RT alone was noninferior to CCRT in terms of 3-year PFS (graphical abstract).