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

• Published in: BMC cancer Vol. 22; no. 1; pp. 1235 - 10
• Main Authors: Luo, Xi, Huang, Xiaodong, Luo, Jingwei, Xiao, Jianping, Wang, Kai, Qu, Yuan, Chen, Xuesong, Zhang, Ye, Wu, Runye, Wang, Jingbo, Zhang, Jianghu, Xu, Guozhen, Gao, Li, Liu, Shaoyan, Wang, Xiaolei, He, Xiaohui, Luo, Dehong, Yi, Junlin
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 29.11.2022; BioMed Central; BMC
• Subjects: 5-Fluorouracil; Cancer; Cancer therapies; Care and treatment; Chemoradiotherapy; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Chemotherapy; Cisplatin; Concurrent chemoradiotherapy; Development and progression; Humans; Hypopharyngeal cancer; Hypopharyngeal Neoplasms - therapy; Induction chemotherapy; Induction Chemotherapy - adverse effects; Induction Chemotherapy - methods; Laryngeal preservation; Larynx; Medical prognosis; Metastases; Methods; Multi-disciplinary treatment; Paclitaxel; Patient outcomes; Patients; Preservation; Progression-Free Survival; Radiation therapy; Radiotherapy; Statistical analysis; Surgery; Survival; Throat cancer; Toxicity; Tumors; China; Hypopharyngeal cancer; Laryngeal preservation; Multi-disciplinary treatment; Induction chemotherapy; Concurrent chemoradiotherapy
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-022-10306-y

Concurrent chemoradiotherapy (CCRT) is a standard treatment choice for locally advanced hypopharyngeal carcinoma. The aim of this study was to investigate whether induction chemotherapy (IC) followed by CCRT is superior to CCRT alone to treat locally advanced hypopharyngeal carcinoma. Patients (n = 142) were randomized to receive two cycles of paclitaxel/cisplatin/5-fluorouracil (TPF) IC followed by CCRT or CCRT alone. The primary end point was overall survival (OS). The secondary end points included the larynx-preservation rate, progression-free survival (PFS), distant metastasis-free survival (DMFS), and toxicities. Ultimately, 113 of the 142 patients were analyzed. With a median follow-up of 45.6 months (interquartile range 26.8-57.8 months), the 3-year OS was 53.1% in the IC + CCRT group compared with 54.8% in the CCRT group (hazard ratio, 1.004; 95% confidence interval, 0.573-1.761; P = 0.988). There were no statistically significant differences in PFS, DMFS, and the larynx-preservation rate between the two groups. The incidence of grade 3-4 hematological toxicity was much higher in the IC+ CCRT group than in the CCRT group (54.7% vs. 10%, P < 0.001). Adding induction TPF to CCRT did not improve survival and the larynx-preservation rate in locally advanced hypopharyngeal cancer, but caused a higher incidence of acute hematological toxicities. ClinicalTrials.gov , number NCT03558035. Date of first registration, 15/06/2018.