A phase III randomized study comparing neoadjuvant chemotherapy with concurrent chemotherapy combined with radiotherapy for locoregionally advanced nasopharyngeal carcinoma: updated long-term survival outcomes.

OBJECTIVE: To determine whether concurrent chemoradiotherapy (CCRT) can improve survival rates compared to the neoadjuvant chemotherapy (NACT) regimen in locoregionally advanced nasopharyngeal carcinoma (NPC) patients. MATERIALS AND METHODS: A total of 338 patients with biopsy-proven NPC were randomly assigned to receive NACT followed by radical radiotherapy (RT) then adjuvant chemotherapy (AC) or CCRT followed by AC. RESULTS: With a median follow-up of 60 months, the 5-year overall survival (OS) rate did not differ significantly between two groups (75.5% vs 79.4% in CCRT and NACT group respectively, P=0.47, HR=0.84, 95%CI 0.53-1.33). Metastasis-free survival (MFS) rate was significantly improved by the CCRT (79.0% vs 86.9%, P=0.05, HR=0.59, 95%CI 0.35-1.00). Subgroup analysis indicated that the benefit of CCRT was derived from N0/N1 tumors (78.0% vs 93.5%, P=0.05, HR=0.35, 95%CI 0.12-0.99). Higher rates of mucositis (52.4% vs. 35.9% P=0.02) and vomiting (13.7% vs. 4.7% P=0.00) were noted in the CCRT arm. Late toxicities were similar in two groups. CONCLUSIONS: The updated results demonstrated no significant survival benefit of CCRT over NACT in patients with locoregionally advanced NPC. CCRT only showed significant MFS efficacy in T3-4N0-1 populations.