Induction TPF followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locally advanced hypopharyngeal cancer: a preliminary result of a randomized phase 2 trial

Purpose: Concurrent chemoradiotherapy (CCRT) was one of the standard treatment choices for locally advanced hypopharyngeal carcinoma. The aim of this study was to investigate whether IC followed by CCRT is superior to CCRT in locally advanced hypopharyngeal carcinoma. Methods and Materials: 142 patients were randomized to receive two cycles of docetaxal /cisplatin/5-fluorouracil (TPF) IC followed by CCRT or CCRT alone. The primary end point was overall survival (OS). Secondary end points included larynx-preservation rate, progression-free survival (PFS), distant metastasis-free survival (DMFS) and toxicities. Results 113 of 142 patients were finally analyzed. With a median follow-up of 45.6 months (IQR 26.8–57.8), the 3-year OS was 53.1% in the IC + CCRT compared with 54.8% in the CCRT (HR, 1.004; 95% CI, 0.573 to 1.761; P = 0.988). There were no statistically significant differences in PFS, DMFS and larynx-preservation rate between the two groups. Grade 3–4 hematological toxicity incidence was much higher in the IC + CCRT group than that in the CCRT group (54.7% vs 10%, P < 0.001). Conclusions Adding induction TPF to CCRT could not improve the survival and larynx-preservation rate in locally advanced hypopharyngeal cancer but in the cost of higher acute hematological toxicities.