Single-center phase 2 trial of toripalimab plus concurrent chemoradiotherapy for recurrent nasopharyngeal carcinoma

A phase 2 trial at Guanxi Medical University Cancer Hospital (Nanning, China) evaluated the combination of toripalimab and concurrent chemoradiotherapy (cCRT) of patients with recurrent nasopharyngeal carcinoma (rNPC). The primary endpoint was objective response rate (ORR). Among 40 patients recruited, the ORR was 87.5% (95% CI 72,0-95.0) with disease control rate 100%. The median progression-free survival (PFS) was 18.1 months (95% CI 15.2-28.8) with 1-, 2-, and 3-year PFS rates of 68.2%, 41.3%, and 15.5%, respectively. The median overall survival (OS) was 28.3 months (95% CI 18.6-NE), with 1-, 2-, and 3- year OS rate of 69.7%, 53.9%, and 44.8%, respectively. The most common acute toxicity were lymphopenia (100%) and anemia (92.5%), whereas most common late toxicities were dry mouth (60.0%) and nasopharyngeal wall necrosis (40.0%). Fatal epistaxis was the cause of death in 22.5% of patients. The authors conclude that toripalimab plus cCRT demonstrated antitumor efficacy in rNPC, with fatal epistaxis as serious treatment-related risk.