Induction chemotherapy combined with immunotherapy in locally advanced head and neck squamous cell carcinoma

BACKGROUND: This study aimed to explore the efficacy and safety of sintilimab combined with induction chemotherapy (IC) in locally advanced head and neck squamous cell carcinoma (HNSCC) patients. METHODS: A total of 163 patients were prospectively enrolled; 98 patients received IC only, and 65 patients received IC with sintilimab. Following neoadjuvant therapy, patients either underwent surgery (31.9%) or chemoradiotherapy (68.1%). Objective response rate (ORR), progression free survival (PFS), overall survival (OS), and toxicities between the two groups were compared. RESULTS: The ORR in the IC group was significantly lower than that in the IC with sintilimab group (68.4% vs 84.6%, P = 0.019). Grade 3 or higher acute toxicity occurred in 15 (15.3%) and 12 (18.5%) patients in the IC and IC with sintilimab groups, respectively. However, this difference was not significant (P = 0.596). After follow-up with a median time of 28.0 months, the IC group had a 2-year PFS rate of 27% (95%CI: 18–36%), whereas the IC with sintilimab group had a 2-year PFS rate of 44% (95%CI: 32–56%), and this difference was significant (P = 0.041). The 2-year OS rates in the IC and IC with sintilimab groups were 61% (95%CI: 52–70%) and 70% (95%CI: 60–80%), respectively, the difference was not significant (P = 0.681). CONCLUSIONS: Addition of sintilimab to IC could provide longer PFS time than traditional chemotherapy regimen, without increasing the toxicity events.