Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma.

PURPOSE: Our previous results showed survival benefits of concurrent chemoradiotherapy (CCRT) in treating stage II nasopharyngeal carcinoma (NPC) compared with radiotherapy (RT) alone. Here, we present the updated 10-year survival results and late toxicity profile to assess the ultimate effectiveness of concurrent chemotherapy.
METHODS: Patients with stage II NPC were randomly assigned to RT arm (n = 114) or to CCRT arm (n = 116) with a concurrent weekly cisplatin regimen. The primary end-point was overall survival (OS).
RESULTS: With a median follow-up of 125 months, significant improvements in OS (83.6% vs 65.8%, P = 0.001), progression-free survival (76.7% vs 64.0%, P = 0.014), cancer-specific survival (86.2% vs 71.9%, P = 0.002), distant-metastasis free survival (94.0% vs 83.3%, P = 0.007) were observed in CCRT arm. In point of locoregional-relapse free survival, the impact of CCRT was not remarkable. The findings were in accordance with our previous report. The survival benefits earned by CCRT mainly reflected in T2N1 population. Although CCRT brought more acute toxic effects (P = 0.001), as presented in previous report, the late toxicities and treatment-associated deaths events were comparable between two arms.
CONCLUSIONS: Ten-year outcomes confirmed that CCRT could improve the OS of stage II patients without adding late toxicities compared with conventional RT.

RCT Entities:   Population Interventions Outcomes