Concurrent chemotherapy for older patients with locoregionally advanced nasopharyngeal carcinoma: A randomized clinical trial.

INTRODUCTION: We aimed to evaluate the efficacy of two different radiotherapy strategies in elderly patients with locally advanced nasopharyngeal carcinoma (NPC) using geriatric assessment. MATERIALS AND METHODS: We conducted a randomized phase 2 trial for older patients (>/= 65 years) with stage III-IVA NPC. Patients were randomized into either intensity-modulated radiotherapy (IMRT) alone (RT Arm) or concurrent chemoradiotherapy (CCRT Arm). The primary endpoint was therapeutic success. The secondary endpoints were survival, safety and geriatric assessment. RESULTS: Between June 1, 2017 and June 11, 2019, 22 patients were allocated to the RT arm and 19 to the CCRT arm. There was therapeutic success in 11 patients (57.9 %) in the CCRT arm and 18 patients (81.8 %) in the RT arm. The median follow-up time was 60.4 months (interquartile range [IQR], 49.8-67.8) months. The five-year locoregional relapse-free survival, cancer-specific survival, and overall survival rates for patients in the CCRT and RT arms were 93.8 % and 85.7 % (p = 0.77), 93.8 % and 80.7 % (p = 0.12), 78.9 % and 56.8 % (p = 0.09), respectively. The five-year distant metastasis-free survival rates for patients in the CCRT and RT arms were 100.0 % and 76.6 % (p = 0.002), respectively. Compared with the CCRT arm, lower incidence of acute toxicities was observed in the RT arm, including grade 1 or higher vomiting, nausea, anemia, and leukopenia (p < 0.05). DISCUSSION: CCRT was not more efficacious than IMRT alone but was more likely to cause acute toxicities in older patients with locally advanced NPC. CCRT should only be used in selected older patients with locally advanced NPC.