Background Neutrophil/lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and methods Pts enrolled in TRIBE trial were included. TRIBE is a multicentre phase III trial randomizing unresectable and previously untreated mCRC pts to receive FOLFOXIRI or FOLFIRI plus bevacizumab. A cut-off value of 3 was adopted to discriminate pts with low (NLR < 3) versus high (NLR ≥ 3) NLR, as primary analysis. As secondary analysis, NLR was treated as an ordinal variable with three levels based on terciles distribution. Results NLR at baseline was available for 413 patients. After multiple imputation at univariate analysis, patients with high NLR had significantly shorter progression-free survival (PFS) [hazard ratio (HR) 1.27 (95% CI 1.05-1.55), P = 0.017] and overall survival (OS) [HR 1.56 (95% CI 1.25-1.95), P < 0.001] than patients with low NLR. In the multivariable model, NLR retained a significant association with OS [HR 1.44 (95% CI 1.14-1.82), P = 0.014] but not with PFS [HR 1.18 (95% CI 0.95-1.46), P = 0.375]. No interaction effect between treatment arm and NLR was evident in terms of PFS (P for interaction = 0.536) or OS (P for interaction = 0.831). Patients with low [HR 0.84 (95% CI 0.64-1.08)] and high [HR 0.73 (95% CI 0.54-0.97)] NLR achieved similar PFS benefit from the triplet and consistent results were obtained in terms of OS [HR 0.83 (95% CI 0.62-1.12) for low NLR; HR 0.82 (95% CI 0.59-1.12) for high NLR]. Conclusion This study confirmed the prognostic role of NLR in mCRC pts treated with bevacizumab plus chemotherapy in the first line, showing the worse prognosis of pts with high NLR. The advantage of the triplet is independent of NLR at baseline.

中文翻译：

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中性粒细胞/淋巴细胞比率在转移性结直肠癌中的预后和预测作用：GONO对TRIBE研究的回顾性分析。

背景中性粒细胞/淋巴细胞比（NLR）（定义为绝对中性粒细胞计数除以绝对淋巴细胞计数）在几种肿瘤疾病中被认为是不良预后因素，但关于不可切除的转移性结直肠癌（mCRC）患者（pts）的数据很少。我们研究的目的是评估TRIBE试验中NLR的预后和预测作用。包括参加TRIBE试验的患者和方法。TRIBE是一项多中心III期试验，将无法切除且先前未治疗的mCRC患者随机分配接受FOLFOXIRI或FOLFIRI加贝伐单抗治疗。作为主要分析，采用临界值3来区分低（NLR <3）与高（NLR≥3）NLR的点。作为次要分析，NLR被视为基于变量分布的三个等级的序数变量。结果413例患者在基线时可进行NLR。在单因素分析中进行多次估算后，具有较高NLR的患者的无进展生存期（PFS）明显缩短[危险比（HR）1.27（95％CI 1.05-1.55），P = 0.017]和总生存期（OS）[HR 1.56] （95％CI 1.25-1.95），P <0.001]。在多变量模型中，NLR与OS [HR 1.44（95％CI 1.14-1.82），P = 0.014]保持显着关联，而与PFS [HR 1.18（95％CI 0.95-1.46），P = 0.375]则不相关。就PFS（相互作用的P = 0.536）或OS（相互作用的P = 0.831）而言，治疗组与NLR之间没有明显的相互作用作用。低[HR 0.84（95％CI 0.64-1.08）]和高[HR 0.73（95％CI 0.54-0.97）] NLR的患者从三联体中获得了相似的PFS获益，并且在OS方面获得了一致的结果[HR 0。低NLR为83（95％CI 0.62-1.12）；高NLR时，HR为0.82（95％CI 0.59-1.12）。结论该研究证实了NLR在贝伐单抗联合化疗一线治疗的mCRC患者中的预后作用，显示高NLR患者的预后较差。三元组的优势在基线时独立于NLR。