CONTINUUM: induction-concurrent chemoradiotherapy with or without sintilimab in locoregionally advanced nasopharyngeal carcinoma
Adding the PD-1 antibody sintilimab to chemotherapy and radiotherapy for advanced, non-metastatic nasopharyngeal cancer raised three-year event-free survival from 76 to 86 percent, with more but manageable side effects.
Overview
Multicentre open-label randomised phase 3 trial at nine hospitals in China: 425 adults with high-risk stage III to IVa nasopharyngeal carcinoma were randomised to gemcitabine-cisplatin induction and concurrent cisplatin radiotherapy with (210) or without (215) 12 cycles of sintilimab.
At a median follow-up of 41.9 months, three-year event-free survival was 86 percent with sintilimab against 76 percent without (stratified hazard ratio 0.59, p 0.019). Grade 3 to 4 adverse events occurred in 74 against 65 percent; grade 3 to 4 immune-related adverse events in 10 percent of the sintilimab group, with two immune-related deaths.
- Three-year event-free survival 86 percent (95% CI 81 to 90) versus 76 percent (70 to 81); hazard ratio 0.59 (0.38 to 0.92), p 0.019.
- Grade 3 to 4 adverse events 74 versus 65 percent; grade 3 to 4 immune-related events 10 percent with sintilimab.
PD-1 blockade added to chemoradiotherapy is a new option for high-risk locoregionally advanced nasopharyngeal carcinoma; longer follow-up will show whether it lengthens survival.
- Chinese population with endemic EBV-related disease; open-label; overall survival immature.
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