Induction TPF versus adjuvant PF after CCRT in locally advanced nasopharyngeal carcinoma: A multicenter, randomized controlled phase III clinical 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 phase III randomized controlled clinical trials for evaluation, so the comparative efficacy and safety between the two approaches remain unclear. This randomized clinical phase III trial recruited patients from May 2018 to July 2021,at 4 institutions in China(NCT03574324), 266 patients were enrolled and randomly assigned to either the IC or AC groups. 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 OS, LRFS, and DMFS between the two treatment cohorts. Both groups had similar compliance rates for radiotherapy and chemotherapy. However, the IC group experienced fewer grade toxic effects during CCRT, such as nausea/vomiting, swallowing, and dryness (101[77.10 %] vs. 114[89.06 %] patients,40 [30.53 %]vs56 [43.75 %] patients and 58 [44.27 %]vs86 [67.19 %] patients, respectively). However,3-4 grade leukopenia and neutrophilia patients were increased(58 [44.27 %]vs28 [21.88 %] patients and 78 [59.54 %]vs24 [18.75 %]) in the IC group. In this randomized clinical trial, IC did not improve 3-year PFS for LA-NPC patients and increased hematological toxicity. Still, the advantage of it is that it did reduce the incidence rates of nausea/vomiting, swallowing, and dry mouth during radiotherapy.