Trial reportAmerican journal of clinical oncology2026
Evaluation of Neutrophil to Lymphocyte Ratio in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Treated With a Combination of Cetuximab and Nivolumab in a Phase II Clinical Trial.
Trial report in American journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03370276 (A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
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23 authors.
Funding
Abstract
objectivesWe report on the biomarker analyses focusing on neutrophil-to-lymphocyte ratios (NLR) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with combined cetuximab and nivolumab.
methodsData were obtained from a phase II trial (NCT03370276). Peripheral blood NLR was obtained at baseline (B-NLR) and on-treatment (OT-NLR; 1 mo from treatment initiation). Tumor NLR (T-NLR) was determined by staining of immune cells in primary tumors. Patients were stratified into high (≥median) or low NLR (<median). The association between NLR with survival outcomes was evaluated.
resultsWhile B-NLR did not correlate with survival or responses, low OT-NLR was associated with superior overall survival (OS; P <0.0001), progression-free survival (PFS; P =0.0002), and overall response ( P <0.001) compared with high OT-NLR. Multivariable analysis further demonstrated that low OT-NLR was associated with superior OS (HR 0.32, 95% CI, 0.17-0.61) and PFS (HR 0.45, 95% CI, 0.25-0.81). Compared with patients with high OT-NLR, a higher proportion of patients with low OT-NLR had OS≥24 months ( P =0.0001). Low OT-NLR was associated with higher baseline PD-L1 combined positive scores ( P =0.037). Low pretreatment T-NLR was associated with superior OS and PFS in multivariable analysis and correlated with superior overall response ( P =0.011).
conclusionsLow OT-NLR and pretreatment T-NLR correlated with superior treatment outcomes in patients with R/M HNSCC treated with cetuximab and nivolumab. Further evaluation of T-NLR to improve patient selection and peripheral blood OT-NLR as a dynamic biomarker contributing to clinical benefit assessment given cetuximab and nivolumab is warranted.
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