Biomarkers of response to camrelizumab combined with apatinib: an analysis from a phase II trial in recurrent/metastatic nasopharyngeal carcinoma

卡瑞利珠单抗联合阿帕替尼治疗复发/转移性鼻咽癌的疗效生物标志物:一项II期临床试验分析

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Abstract

BACKGROUND: This study aims to develop a peripheral blood-based model that can predict the response to the combination therapy of camrelizumab and apatinib as a second-line or later-line treatment regimen in patients with recurrent/metastatic nasopharyngeal carcinoma (R/M-NPC). METHODS: We collected peripheral blood routine data from 72 patients with R/M-NPC from two clinical trial studies (NCT04547088, NCT04548271). Utilising the least absolute shrinkage and selection operator Cox regression model, we built a peripheral blood signature and developed a prognostic nomogram through multivariable analysis. Spectral flow cytometry analysed peripheral blood mononuclear cell immunophenotyping. RESULTS: Six indicators (WBC, MCV, HCT, MCHC, P-LCR, MLR) were included to construct the peripheral blood signature. By combining this signature with Epstein-Barr virus DNA, distant lymph node metastasis and previous PD-1 inhibitor treatment, we constructed a peripheral blood-based nomogram that showed favourable performance. High-risk individuals had lower overall survival than low-risk individuals (P < 0.05). Immunophenotyping revealed that the high-risk individuals had increased monocytic myeloid-derived suppressor cells, Tregs and decreased CD8 effector memory cells (P < 0.05). CONCLUSIONS: We established a model that could predict the prognosis of combined therapy. The model could predict outcomes and reflect the systemic immune and inflammatory status, which is beneficial for risk stratification and therapeutic modification.

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