Prognostic factor analysis and long-term results of the TAX 323 (EORTC 24971) study in unresectable head and neck cancer patients
- PMID: 34425403
- DOI: 10.1016/j.ejca.2021.07.034
Prognostic factor analysis and long-term results of the TAX 323 (EORTC 24971) study in unresectable head and neck cancer patients
Abstract
Background: In the TAX 323 (EORTC 24971) phase III trial enrolling patients with unresectable locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), the addition of docetaxel (T) to cisplatin and 5-fluorouracil (PF)-based induction chemotherapy prior to definite radiotherapy significantly improved progression-free survival (PFS) and overall survival (OS).
Methods: The data were updated for PFS, OS and treatment-related long-term side-effects. Baseline clinical and laboratory data of 17 variables were collected and subjected to univariate and multivariate prognostic factor analyses for OS.
Results: All 358 patients randomised between 1999 and 2002 were included in the long-term analysis with a median follow-up of 8.6 years. The primary end-point of PFS remained significantly improved with TPF compared with PF (adjusted hazard ratio [HR], 0.70; 95% CI, 0.56-0.88, p = 0.002), translating into a persisting benefit in OS (adjusted HR, 0.75; 95% CI, 0.60-0.95, p = 0.015). Long-term side-effects in the TPF/PF arms comprised tracheostomy (7%/5%), feeding tube dependency (3%/6%) and gastrostomy (11%/11%). Second malignancy occurred in 8%/3%, respectively. Out of 177 patients randomised to the TPF arm, 160 were included in the multivariate analysis. Grade 2 or more dysphagia (p = 0.002) and grade 2 or more pain (p = 0.004) at baseline were identified as independent negative prognostic factors. In addition, OS differed across primary tumour sites (p = 0.027) and was worse in patients with a higher N-stage (p = 0.025).
Conclusions: In LA-SCCHN patients treated with sequential chemoradiotherapy, TPF induction chemotherapy demonstrated long-lasting efficacy, superior to the PF regimen. Higher-grade dysphagia and pain are unfavourable prognosticators.
Keywords: EORTC 24971/TAX 323 phase III clinical trial; Head and neck cancer; Induction chemotherapy; Late toxicity; Overall survival; Prognostic factor.
Copyright © 2021. Published by Elsevier Ltd.
Conflict of interest statement
Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Petr Szturz: Has had in the last 3 years or has advisory relationships with: Merck-Serono, Servier, and BMS. Marie Vinches has nothing to declare. Éva Remenár has nothing to declare. Carla M L van Herpen: Has had in the last 3 years or has advisory/consultant relationships with: Bayer, Bristol-Myers Squibb, Ipsen, MSD and Regeneron and research grant/funding relationships with: Astra Zeneca, Bristol-Myers Squibb, MSD, Merck, Ipsen, Novartis and Sanofi. Cyril Abdeddaim: Has had in the last 3 years consulting/advisory relationships with GlaxoSmithKline. John S Stewart has nothing to declare. Catherine Fortpied has nothing to declare. Jan B. Vermorken: Has had in the last 3 years or has consulting/advisory relationships with: Immunomedics, Innate Pharma, Merck-Serono, Merck Sharp & Dome Corp, PCI Biotech, Synthon Biopharmaceuticals, Debiopharm, Cue Biopharma, Nanobiotix, and WntResearch and received lecture fees from Merck-Serono, MSD and BMS.