Induction chemotherapy plus camrelizumab combined with concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma in non-endemic areas: a phase 2 clinical trial in North China.

Abstract

Immunotherapy has been confirmed efficient in recurrent or metastatic nasopharyngeal carcinoma (NPC), but its role in the locoregionally advanced setting is undetermined. Previous evidence in non-endemic areas of NPC is also lacking. This study evaluated the efficacy and safety of induction chemotherapy plus camrelizumab followed by concurrent chemoradiotherapy (CCRT) for patients with locoregionally advanced NPC in non-endemic areas. In this phase 2 trial, patients born and living in North China with untreated stage III to IVa NPC were enrolled. All patients received two 21-day cycles of camrelizumab (200 mg) plus docetaxel (75 mg/m²) and cisplatin (75 mg/m²), followed by intensity modulated radiotherapy and concurrent cisplatin (80 mg/m² for two 21-day cycles). After CCRT, patients received camrelizumab maintenance for 12 cycles. The primary endpoint was 3-year disease-free survival (DFS) rate. From February 2021 to September 2023, a total of 57 patients were included for analysis. The objective response rate was 92.8% after induction therapy and 100% after CCRT. With a median follow-up time of 21 months, the 3-year DFS rate was 84%. The 3-year locoregional recurrence-free survival, distant metastasis-free survival, and overall survival rates were 95.8%, 90.9%, and 89.5%, respectively. The most common grade 3 or 4 treatment-related adverse events were leukopenia and neutropenia during induction therapy, and weight loss and lymphopenia during CCRT. Induction immunochemotherapy combined with CCRT shows promising antitumor activity with a manageable safety profile in patients with locoregionally advanced NPC from non-endemic areas, which deserves further validation. ClinicalTrials.gov Identifier: NCT04782765.