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实体瘤患者化疗周期 2-6 期间发热性中性粒细胞减少症的周期特异性风险评分的制定和验证:FENCE 评分。

Development and validation of a cycle-specific risk score for febrile neutropenia during chemotherapy cycles 2-6 in patients with solid cancers: The FENCE score.

机构信息

Centre for Health, Immunity and Infections (CHIP), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, University College London, London, United Kingdom.

出版信息

Int J Cancer. 2020 Jan 15;146(2):321-328. doi: 10.1002/ijc.32249. Epub 2019 Mar 28.

DOI:10.1002/ijc.32249
PMID:30839100
Abstract

The absolute risk reduction by prophylaxis in chemotherapy-induced febrile neutropenia (FN) is largest in patients at highest underlying risk. Therefore, reliable predictive models are needed. Here, we develop and validate such a model for risk of FN during chemotherapy cycles 2-6. A prediction score for risk of FN during the first cycle has recently been published. Patients with solid cancers initiating first-line chemotherapy in 2010-2016 were included. Cycle-specific risk factors were assessed by Poisson regression using generalized estimating equations and random split sampling. The derivation cohort included 4,590 patients treated with 15,419 cycles, wherein 326 (2.1%) FN events occurred. Predictors of FN in multivariable analyses were: higher predicted risk of FN in the first cycle, platinum- or taxane-containing therapies, concurrent radiotherapy, treatment in cycle 2 compared to later cycles, previous FN or neutropenia and not receiving granulocyte colony-stimulating factors. Each predictor added between -2 and 8 points to each patient's score (median score 4; interquartile range, 1-6). The incidence rate ratios for developing FN in the intermediate (score 1-4), high (score 5-6) and very high risk groups (score ≥7) were 7.8 (95% CI, 2.4-24.9), 18.6 (95% CI, 5.9-58.8) and 51.7 (95% CI, 16.5-162.3) compared to the low risk group (score ≤0), respectively. The score had good discriminatory ability with a Harrell's C-statistic of 0.78 (95% CI, 0.76-0.80) in the derivation and 0.75 (95% CI, 0.72-0.78) in the validation cohort (patient n = 2,295, cycle n = 7,670). The Cycle-Specific Risk of FEbrile Neutropenia after ChEmotherapy score is the first published method to estimate cycle-specific risk of FN.

摘要

预防性治疗在化学疗法引起的发热性中性粒细胞减少症(FN)中的绝对风险降低幅度在风险最高的患者中最大。因此,需要可靠的预测模型。在这里,我们开发并验证了一种用于预测第 2-6 个化疗周期 FN 风险的模型。最近发表了一种用于预测第 1 个化疗周期 FN 风险的预测评分。纳入了 2010 年至 2016 年间接受一线化疗的实体瘤患者。使用广义估计方程和随机分割抽样的泊松回归评估周期特异性危险因素。推导队列包括 4590 名接受 15419 个周期治疗的患者,其中 326 例(2.1%)发生 FN 事件。多变量分析中 FN 的预测因子为:第 1 个周期 FN 风险预测较高、含铂或紫杉烷类药物治疗、同期放疗、与后续周期相比在第 2 周期治疗、既往 FN 或中性粒细胞减少症和未使用粒细胞集落刺激因子。每个预测因子为每位患者的评分增加 2 到 8 分(中位数评分 4;四分位距,1-6)。在中等风险(评分 1-4)、高风险(评分 5-6)和极高风险(评分≥7)组中,发生 FN 的发病率比为 7.8(95%CI,2.4-24.9)、18.6(95%CI,5.9-58.8)和 51.7(95%CI,16.5-162.3)与低风险组(评分≤0)相比。该评分在推导队列中的 Harrell's C 统计量为 0.78(95%CI,0.76-0.80),在验证队列中的为 0.75(95%CI,0.72-0.78),具有良好的区分能力(患者 n=2295,周期 n=7670)。该模型是首个用于评估化疗后 FN 风险的预测评分。

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