Effects of Induction Docetaxel, Platinum, and Fluorouracil Chemotherapy in Patients With Stage III or IVA/B Nasopharyngeal Cancer Treated With Concurrent Chemoradiation Therapy: Final Results of 2 Parallel Phase 2 Clinical Trials

摘要

BACKGROUND: The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. METHODS: Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC. The induction chemotherapy, which preceded standard intensity-modulated radiation therapy/platinum-based chemoradiation, consisted of 3 cycles of docetaxel (75mg/m(2) on day 1), cisplatin (75mg/m(2) on day 1), and a continuous infusion of fluorouracil (500mg/m(2)/d on days 1-5) every 4 weeks. The primary endpoint for both trials was 5-year overall survival (OS). RESULTS: Between January 2007 and July 2010, 52 eligible patients with stage III NPC and 64 eligible patients with nonmetastatic stage IV NPC were accrued to the 2 trials. With a median follow-up of 67 months, the 5-year OS, progression-free survival, distant metastasis-free survival, and local progression-free survival (LPFS) rates were all improved in comparison with historical benchmarks for patients with stage III or IVA/IVB NPC. Multivariate analyses indicated that T and N classifications (T1/T2 vs T3/T4 and N3 vs N0-N2) were the only significant prognosticators for OS. The number of induction chemotherapy cycles was the only significant prognostic factor for predicting LPFS. CONCLUSIONS: TPF-based induction chemotherapy appears to significantly improve outcomes in comparison with historical data when it is administered before CCRT for locoregionally advanced NPC. A phase 3 trial is currently being performed to confirm this benefit. (C) 2017 American Cancer Society.