Phase II trial of concurrent chemoradiotherapy with S-1 versus weekly cisplatin for locoregionally advanced nasopharyngeal carcinoma

Abstract

This is a prospective randomized trial performed to compare the efficacy of concurrent chemoradiotherapy (CCRT) + S‐1 (oral fluoropyrimidine) with that of CCRT + cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma. A total of 105 eligible patients were randomly assigned to receive CCRT with S‐1 (S‐1 arm, n=50) or cisplatin weekly (control arm, n=55). Patients in the S‐1 arm received CCRT plus S‐1 (40‐60 mg, twice daily for 4 consecutive weeks. Patients in the control arm received standard CCRT with weekly cisplatin. All the patients were included in an intention‐to‐treat survival analysis. Our results demonstrated that the S‐1 and control arms did not differ significantly in terms of complete response, partial response, progression‐free survival or overall survival (all P‐values >0.05). However, the two arms varied significantly regarding certain grade 3‐4 toxicities, including leukopenia, 5.5 vs. 22.0% (P=0.013); mucositis, 20.0 vs. 46.0% (P=0.004); dermatitis, 15.5 vs. 32.7% (P=0.011); and nausea, 9.1 vs. 41.6% (P<0.001) for the S‐1 and control arms, respectively. In conclusion, CCRT with S‐1 was found to be similar in efficacy but superior in terms of toxicity compared to the standard CCRT with weekly cisplatin.