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Therapeutic Drug Monitoring in Oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology Recommendations for 5-Fluorouracil Therapy.肿瘤治疗药物监测：国际治疗药物监测和临床毒理学协会关于氟尿嘧啶治疗的建议。
Clin Pharmacol Ther. 2019 Mar;105(3):598-613. doi: 10.1002/cpt.1124. Epub 2018 Sep 11.
2
5-Fluorouracil Response Prediction and Blood Level-Guided Therapy in Oncology: Existing Evidence Fundamentally Supports Instigation.氟尿嘧啶反应预测和肿瘤学中的血药浓度指导治疗：现有证据从根本上支持启动。
Ther Drug Monit. 2020 Oct;42(5):660-664. doi: 10.1097/FTD.0000000000000788.
3
Therapeutic drug monitoring of 5-fluorouracil.5-氟尿嘧啶的治疗药物监测
Cancer Chemother Pharmacol. 2016 Sep;78(3):447-64. doi: 10.1007/s00280-016-3054-2. Epub 2016 May 23.
4
How can we best monitor 5-FU administration to maximize benefit to risk ratio?我们应如何最佳监测 5-FU 的给药以实现效益风险比最大化？
Expert Opin Drug Metab Toxicol. 2018 Dec;14(12):1303-1313. doi: 10.1080/17425255.2018.1550484. Epub 2018 Nov 23.
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Clinical Benefit of Therapeutic Drug Monitoring in Colorectal Cancer Patients Who Received Fluorouracil-Based Chemotherapy.氟尿嘧啶为基础化疗的结直肠癌患者治疗药物监测的临床获益。
Med Sci Monit. 2021 Jul 31;27:e929474. doi: 10.12659/MSM.929474.
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Individual 5-Fluorouracil Dose Adjustment via Pharmacokinetic Monitoring Versus Conventional Body-Area-Surface Method: A Meta-Analysis.通过药代动力学监测与传统体表面积法进行个体5-氟尿嘧啶剂量调整：一项荟萃分析。
Ther Drug Monit. 2016 Feb;38(1):79-86. doi: 10.1097/FTD.0000000000000238.
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Therapeutic drug monitoring in oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology consensus guidelines for imatinib therapy.肿瘤治疗药物监测：国际治疗药物监测和临床毒理学协会伊马替尼治疗共识指南。
Eur J Cancer. 2021 Nov;157:428-440. doi: 10.1016/j.ejca.2021.08.033. Epub 2021 Sep 28.
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Evaluation of 5-fluorouracil pharmacokinetic models and therapeutic drug monitoring in cancer patients.评估癌症患者 5-氟尿嘧啶的药代动力学模型和治疗药物监测。
Pharmacogenomics. 2013 May;14(7):799-811. doi: 10.2217/pgs.13.54.
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Prospective, Multicenter Study of 5-Fluorouracil Therapeutic Drug Monitoring in Metastatic Colorectal Cancer Treated in Routine Clinical Practice.5-氟尿嘧啶治疗药物监测在常规临床实践中治疗转移性结直肠癌的前瞻性多中心研究。
Clin Colorectal Cancer. 2016 Dec;15(4):381-388. doi: 10.1016/j.clcc.2016.04.001. Epub 2016 May 7.
10
[5-fluorouracil therapeutic drug monitoring: Update and recommendations of the STP-PT group of the SFPT and the GPCO-Unicancer].[5-氟尿嘧啶治疗药物监测：法国肿瘤治疗药物监测协会（SFPT）的治疗药物监测与药学治疗小组（STP-PT）及法国国立癌症研究所联盟（GPCO-Unicancer）的更新与建议]
Bull Cancer. 2018 Sep;105(9):790-803. doi: 10.1016/j.bulcan.2018.06.008. Epub 2018 Aug 10.

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Determination of 5-Fluorouracil in Dried Blood Spots for Therapeutic Drug Monitoring and Adverse Event Assessment in Breast Cancer Patients.用于乳腺癌患者治疗药物监测和不良事件评估的干血斑中5-氟尿嘧啶的测定
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Real-world study on fluoropyrimidine-related toxicity outcomes in cancer patients with select DPYD variant alleles that received DPYD genotype-guided dosing.对接受二氢嘧啶脱氢酶（DPYD）基因型指导给药的携带特定DPYD变异等位基因的癌症患者中氟嘧啶相关毒性结果的真实世界研究。
Int J Cancer. 2025 Jun 19. doi: 10.1002/ijc.70005.
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JCO Precis Oncol. 2025 Jun;9:e2500062. doi: 10.1200/PO-25-00062. Epub 2025 Jun 6.
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Pharmaceuticals (Basel). 2025 Apr 29;18(5):653. doi: 10.3390/ph18050653.
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Feasibility and population exposure of 5-fluorouracil using therapeutic drug monitoring (PREDICT-5FU): A multicentre clinical trial.使用治疗药物监测的5-氟尿嘧啶的可行性和人群暴露情况（PREDICT-5FU）：一项多中心临床试验。
Br J Clin Pharmacol. 2025 Jul;91(7):1965-1974. doi: 10.1002/bcp.70006. Epub 2025 Feb 23.
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Thymine as potential biomarker to predict 5-FU systemic exposure in patients with gastro-intestinal cancer: a prospective pharmacokinetic study (FUUT-trial).胸腺嘧啶作为预测胃肠道癌患者5-氟尿嘧啶全身暴露的潜在生物标志物：一项前瞻性药代动力学研究（FUUT试验）。
Cancer Chemother Pharmacol. 2025 Feb 15;95(1):34. doi: 10.1007/s00280-025-04759-8.
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From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology.从前瞻性评估到实践：肿瘤学中基于模型的剂量优化
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Phase I trial of ATR inhibitor elimusertib with FOLFIRI in advanced or metastatic gastrointestinal malignancies (ETCTN 10406).ATR抑制剂埃利穆塞替布联合FOLFIRI用于晚期或转移性胃肠道恶性肿瘤的I期试验（ETCTN 10406）
Cancer Chemother Pharmacol. 2025 Jan 22;95(1):27. doi: 10.1007/s00280-024-04745-6.
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Association Between Changes in Plasma Capecitabine Concentrations and Adverse Events in the Treatment of Colorectal Cancer.血浆卡培他滨浓度变化与结直肠癌治疗中不良事件的关联
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本文引用的文献

1
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Dihydropyrimidine Dehydrogenase Genotype and Fluoropyrimidine Dosing: 2017 Update.临床药物遗传学实施联盟（CPIC）关于二氢嘧啶脱氢酶基因型和氟嘧啶剂量的指南：2017 年更新。
Clin Pharmacol Ther. 2018 Feb;103(2):210-216. doi: 10.1002/cpt.911. Epub 2017 Nov 20.
2
Efficacy, safety, tolerability and price of newly approved drugs in solid tumors.新批准用于实体瘤的药物的疗效、安全性、耐受性和价格。
Cancer Treat Rev. 2017 May;56:1-7. doi: 10.1016/j.ctrv.2017.03.011. Epub 2017 Apr 9.
3
Pharmacokinetic dose adjustment of 5-FU in modified FOLFOX7 plus bevacizumab for metastatic colorectal cancer in Japanese patients: a-JUST phase II clinical trial.在日本患者中，改良FOLFOX7联合贝伐单抗治疗转移性结直肠癌时5-氟尿嘧啶的药代动力学剂量调整：a-JUST II期临床试验
Cancer Chemother Pharmacol. 2016 Dec;78(6):1253-1261. doi: 10.1007/s00280-016-3184-6. Epub 2016 Nov 2.
4
Emergency use of uridine triacetate for the prevention and treatment of life-threatening 5-fluorouracil and capecitabine toxicity.尿苷三乙酸酯在预防和治疗危及生命的5-氟尿嘧啶和卡培他滨毒性中的紧急使用。
Cancer. 2017 Jan 1;123(2):345-356. doi: 10.1002/cncr.30321. Epub 2016 Sep 13.
5
FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.FDA 批准：三乙酸尿苷用于氟尿嘧啶或卡培他滨用药过量的患者，或这些药物给药后出现早期严重毒性的患者。
Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11.
6
Prospective, Multicenter Study of 5-Fluorouracil Therapeutic Drug Monitoring in Metastatic Colorectal Cancer Treated in Routine Clinical Practice.5-氟尿嘧啶治疗药物监测在常规临床实践中治疗转移性结直肠癌的前瞻性多中心研究。
Clin Colorectal Cancer. 2016 Dec;15(4):381-388. doi: 10.1016/j.clcc.2016.04.001. Epub 2016 May 7.
7
Therapeutic drug monitoring of 5-fluorouracil.5-氟尿嘧啶的治疗药物监测
Cancer Chemother Pharmacol. 2016 Sep;78(3):447-64. doi: 10.1007/s00280-016-3054-2. Epub 2016 May 23.
8
Pharmacokinetic and Pharmacodynamic Analyses of 5-Fluorouracil in East-Asian Patients with Nasopharyngeal Carcinoma.东亚鼻咽癌患者5-氟尿嘧啶的药代动力学和药效学分析
Clin Pharmacokinet. 2016 Oct;55(10):1205-1216. doi: 10.1007/s40262-016-0395-2.
9
Upfront Genotyping of DPYD*2A to Individualize Fluoropyrimidine Therapy: A Safety and Cost Analysis. upfront 基因分型 DPYD*2A 以实现氟尿嘧啶类药物个体化治疗：安全性和成本分析。
J Clin Oncol. 2016 Jan 20;34(3):227-34. doi: 10.1200/JCO.2015.63.1325. Epub 2015 Nov 16.
10
Evaluation of an oral uracil loading test to identify DPD-deficient patients using a limited sampling strategy.使用有限采样策略评估口服尿嘧啶负荷试验以识别二氢嘧啶脱氢酶缺乏患者。
Br J Clin Pharmacol. 2016 Mar;81(3):553-61. doi: 10.1111/bcp.12821. Epub 2016 Jan 8.

肿瘤治疗药物监测：国际治疗药物监测和临床毒理学协会关于氟尿嘧啶治疗的建议。

Therapeutic Drug Monitoring in Oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology Recommendations for 5-Fluorouracil Therapy.

机构信息

Cancer Therapeutics Program, UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.

Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

出版信息

Clin Pharmacol Ther. 2019 Mar;105(3):598-613. doi: 10.1002/cpt.1124. Epub 2018 Sep 11.

DOI:10.1002/cpt.1124
PMID:29923599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6309286/
Abstract

5-Fluorouracil (5-FU) is dosed by body surface area, a practice unable to reduce the interindividual variability in exposure. Endorsed by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT), we evaluated clinical evidence and strongly recommend TDM for the management of 5-FU therapy in patients with colorectal or head-and-neck cancer receiving common 5-FU regimens. Our systematic methodology provides a framework to evaluate published evidence in support of TDM recommendations in oncology.

摘要

5-氟尿嘧啶（5-FU）按体表面积给药，但这种方法无法降低个体间暴露的变异性。我们评估了临床证据，并强烈推荐治疗药物监测（TDM）用于接受常见 5-FU 方案治疗结直肠癌或头颈部癌症的患者的 5-FU 治疗管理，这一实践得到了国际治疗药物监测和临床毒理学协会（IATDMCT）的认可。我们的系统方法为评估支持肿瘤学 TDM 建议的已发表证据提供了一个框架。