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.