TPF induction chemotherapy versus PF adjuvant chemotherapy plus concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma: a multicenter, randomized controlled phase III trial

Abstract

The efficacy and safety of TPF-induced chemotherapy(IC) combined with concurrent chemoradiotherapy(CCRT) compared to CCRT and sequential PF-adjuvant chemotherapy(AC) lack randomized controlled clinical trials for evaluation, so the comparative efficacy and safety between the two approaches remain unclear. In this phase III trial(NCT03574324), 266 patients were enrolled and randomly assigned to either the IC group or the AC group. The IC group received TPF followed by CCRT, while the AC group received CCRT followed by PF. We are reporting on the primary outcome of progression-free survival (PFS) and secondary endpoints of overall survival(OS), locoregional relapse-free survival(LRFS), distant metastasis-free survival(DMFS), and toxicity profile. The 3-year PFS was similar between the two groups, with 79% for the IC group and 74.5% for the AC group (P = 0.454) at a median follow-up of 39 months. Similar findings were observed with no significant disparities in terms of OS, LRFS, and DMFS between the two treatment cohorts. Both groups had similar compliance rates for radiotherapy and chemotherapy, but the IC group experienced fewer toxic effects during CCRT, such as swallowing and dryness (40 [30.53%] vs 56 [43.75%] patients and 58 [44.27%] vs 86 [67.19%] patients, respectively).In this randomized clinical trial, IC did not improve 3-year PFS for LA-NPC patients but it did reduce the incidence rates of swallowing and dry mouth during radiotherapy.