1. Patients in the sintilimab group reported a significantly greater event-free survival at 36 months compared to the standard therapy group.

2. Grade 3-4 adverse events were slightly more common in the sintilimab group.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Anti-PD-1 therapy is used to treat metastatic and refractory nasopharyngeal carcinoma, yet its role in locoregionally advanced disease remains unclear. Sintilimab, a novel PD-1 inhibitor, has shown some promise when added to the standard chemoradiotherapy regimen, although further evidence is needed. This randomized controlled trial aimed to evaluate whether the addition of sintilimab improves event-free survival compared to standard therapy alone in high-risk non-metastatic stage III–IVa nasopharyngeal carcinoma. The primary outcome of this study was event-free survival from randomization to disease recurrence or death, while a key secondary outcome was the incidence of adverse events. According to study results, sintilimab significantly improved event-free survival compared to standard therapy. Although this study was well done, it was limited by the relatively short follow-up duration to establish long-term efficacy.

Click to read the study in The Lancet

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In-depth [randomized controlled trial]: Between Dec 21, 2018, and Mar 31, 2020, 557 patients were assessed for eligibility across 9 hospitals in China. Included were patients aged 18-65 years with stage III–IVa locoregionally advanced nasopharyngeal carcinoma, meeting specific criteria excluding T3–4N0 and T3N1 stages. Altogether, 425 patients (210 in sintilimab and 215 in placebo) were included in the final analysis. The primary outcome of event-free survival at 36 months was significantly higher in sintilimab than standard therapy (86% vs. 76%, hazard rate [HR] 0.59, 95% confidence interval [CI] 0.38-0.92, p=0.019). The secondary outcome of grade 3-4 adverse events was more common in the treatment group (74% vs. 65%) with stomatitis (33% vs. 30%) and leukopenia (26% vs. 22%) being most frequent. Overall, findings from this study suggest that adding sintilimab to standard chemoradiotherapy improves event-free survival in patients with high-risk locoregionally advanced nasopharyngeal carcinoma.

Image: PD

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